cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment

Abstract

Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee.

A 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with OA of the knee will be randomized to receive 1 intra-articular monthly injection of 5 mL of one of the following: 75 mg/mL of Kondrium, 82.5 mg/mL of Kondriumf or 8 mg/mL of methylprednisolone once a month during 3 months. The primary efficacy variable will be the change from baseline to final assessment in the Western Ontario and McMaster University OA index (WOMAC subscale score for pain), and Lequesne´s functional index.

The WOMAC osteoarthritis index is a validated, multidimensional, disease specific, health status measure. It probes clinically important patient relevant symptoms in the areas of pain, stiffness and physical function in patients with hip and/or knee osteoarthritis. It consists of 24 questions in three separated subscales (5 questions on pain subscale, 17 questions on physical function subscales and 2 questions on stiffness subscale), each scored in analog scale from 0 to 10 points (0 representing no pain, 10 representing extreme pain). Each subscale score was weighed 10 points, thus 30 was the maximum punctuation for WOMAC total score.

The Lequesne index is a 10-question interview-style survey given to patients with osteoarthritis of the knee. It has 5 questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and 4 questions about daily activities. The total questionnaire is scored on a 0 to 24 scale, with lower scores meaning less functional impairment.

Eligibility Criteria:
Inclusion Criteria:

* age \> 40 years
* symptomatic evidence of OA in the knee for at least 1 year
* radiographic evidence of Kellgren and Lawrence grade II to IV OA of the knee
* no intra-articular injection of corticosteroids within the last 3 months

Exclusion Criteria:

* any history of adverse reaction to the study drugs
* current pregnancy status
* uncontrolled hypertension
* active infection
* undergone surgery/arthroscopy within three months
* diagnosis of radiographic OA of Kellgren and Lawrence grade I
BioTechCOACH-ForALL: Development of Mental and Physical Exercise Systems, Clinical Recording, Supervisory Analytical Large-scale Data and Virtual Guidance of Vulnerable Population Groups

This would be a single center, parallel, two group randomized controlled pilot study that is designed to assess the feasibility and efficacy of the Virtual Coach Program in elderly patients with heart failure.

This would be a single center, parallel, two group randomized controlled pilot study that is designed to assess the feasibility and efficacy of the Virtual Coach Program in elderly patients with heart failure. Sixteen (16) subjects will be enrolled to allow 8 subjects to be randomly assigned to each arm. The study will be conducted in Thessaloniki/Greece. The study is expected to complete enrollment in approximately 3 months. Participants will be randomly randomized to either the intervention group (use of Virtual Coach program and usual care) or the control group (use of usual care alone) after successfully fulfilling all inclusion and exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged \>55 years old with any of the following conditions, diagnosed according to appropriate international guidelines criteria

   a) Heart failure of any etiology, with either reduced or preserved ejection fraction
2. Subjects must be in WHO Functional Class II-IV
3. Subjects must be on stable clinical condition and on stable medical treatment for the underlying disease for at least three months prior to randomization
4. Willing and able to comply with scheduled visits, treatment plan, and trial procedures
5. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

1. Patients with heart conditions other that those listed above
2. Subjects who have unstable disease with evidence of decompensation, recent hospitalization or undergoing investigation for clinical deterioration
3. Subjects with recent history of chest pain, palpitations, lightheadedness, dizziness, or syncope on exertion
4. Subjects with contraindications to physical activity or with physical obstruction to perform the prescribed training program (eg patients confined on wheel chair etc)
5. Subjects with any severe acute or chronic medical or psychiatric condition that may increase the risk associated with trial participation or may interfere with the interpretation of trial results
6. Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator
7. Subjects participating in any other experimental studies
8. Subjects not willing to provide signed informed consent.
Impact of COVID-19 Pandemic on Orthopaedic Practice

The COVERT Collaborative is led by a group of academic surgeons that is looking into the impact of the unprecedented COVID-19 pandemic on Trauma and Orthopaedic practice. This will involve both trauma and elective procedures, as well as mortality rates, operative and anaesthetic case mix. The information will help to shape service reconfiguration and enhance patient-specific treatment especially in the threat of potential subsequent waves and future pandemics.

In response to the health crisis, it is the responsibility of clinicians to audit and collaborate in order to observe the impact of the pandemic on clinical practice. With the restructure of the health infrastructure, there is likely to be changes to the nature of acute referrals to Trauma and Orthopaedics, operative and anaesthetic casemix, polytrauma and open fractures as well as the role of technology to reduce viral transmission. Patient safety ought to be prioritised at all times but a national narrative is required to equip healthcare services to counter the pandemic at various time intervals post-social distancing and lockdown at 1.5, 3, 6, 12, 18 and 24 months. This will act as an audit to compare and contrast if the reconfiguration of healthcare services is abiding by the governmental, DoH, NHS, WHO, RCS and BOA (BOAST) policies and guidelines.

Eligibility Criteria:
Inclusion Criteria:

* anyone presenting with orthopaedic trauma to the Emergency Department who has been referred to the on-call Trauma and Orthopaedic team for further management.

Exclusion Criteria:

* spinal trauma
Cognitive Testing Online in Parkinson's Disease

This is a feasibility and pilot study. Though large-scale online neurocognitive testing is increasingly being done in psychiatry, there are no such efforts in Parkinson's research. Thus a large part of this pilot study will be to demonstrate feasibility and reliability, and use this experience to develop a feasible protocol for ongoing research. The specific short-term objectives are:

1. To establish the feasibility of performing large-scale deep cognitive phenotyping using online cognitive testing.
2. To demonstrate that online neurocognitive testing is valid and reliable in a smaller sample of locally recruited participants tested both in-lab and online.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Parkinson's disease by neurologist or healthy individual with no diagnosis of any neurological illness

Exclusion Criteria:

* Psychotic spectrum disorders, active uncontrolled depression, advanced dementia (i.e. needing assistance with daily activities such as dressing or bathing), major stroke, major head injury, epilepsy requiring anti-seizure medications
A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America

Data from niraparib treatment is not available in real-world setting in Latin America. The present study aims to collect data from patients treated with niraparib within the Latin America Expanded Access Program (EAP) in clinical practice in Brazil and Argentina and who meet the eligibility criteria for this study, without additional intervention.

This is a multicenter, retrospective and prospective (bi-directional) patient chart review, observational (non-interventional) study, in the patients treated within the Latin America EAP. The study is planned to be conducted at oncology services distributed in Argentina and Brazil. Its multicenter nature aims to improve the representativeness of the study population in the region. Patient's medical records will be screened by local clinical staff to assess for eligibility according to selection criteria in the sites previously involved in the EAP. The follow-up data collection will be performed using a combination of medical records and patients' interviews. For patients that had interrupted the treatment before study start, the study comprises a single study visit with retrospective data collection from medical charts, followed by follow-up overall survival status, progression-free survival and time to next treatment performed by medical chart review or by phone call at month 12, month 24 and month 36 from the first dose of niraparib. For those that were still in treatment, data collection will be performed during the regular visits to the services involved in the study, using a combination of medical records abstraction and patient's interviews.

Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced OC in response following first line platinum-based chemotherapy who were treated with niraparib within the EAP in Argentina and Brazil;
* Patients who have received at least one dose of niraparib in the EAP.

Exclusion Criteria:

* Patients without medical record available (lost, empty or irretrievable clinical information).
Levobupivacaine Prolonged Wound Infusion for Postoperative Pain Relief After Breast Surgery

The aim of the study is to evaluate efficacy and safety of long term (14 days) wound infusion with levobupivacaine in patients with breast cancer undergoing mastectomy with immediate breast reconstruction: this is a double blind, randomized, parallel group study. The study moves from the concept that nociceptive stimulus last further than 48 hours after surgical intervention: long term analgesia is necessary to provide a real benefit to the patient and provide central sensitization. Intralesional catheter is placed at the end of surgery. In the first 24 postoperative hours we provide continuous wound infusion with levobupivacaine 0,25% 5ml/h with morphine Patient Controlled Analgesia (PCA) when NRS \>4. From the second postoperative day morphine PCA is removed and patients are randomized to receive levobupivacaine 0,25% or saline, released with 5 ml boluses and lock-out of 2 hours, with rescue analgesia with tramadol 37,5 mg + acetaminophen 325 mg oral fix combination (Patrol). Intralesional catheter is taken off 14 days after surgical intervention or after 36 hours of non-use.

Pain evaluation (NRS at rest and movement) and oral rescue doses consumption are performed; pain physicians also care about any catheter-related or drug-related side effect, registering number of total boluses. Patients are provided with a home diary for pain scores to be filled and brought back when surgical visit is performed. A phone interview at 1 and 3 month is performed to investigate pain chronicization.

Surgical evaluation is provided, also to establish any catheter-related infective or healing complication.

Physiatric evaluation before the intervention and 1 and 3 months is provided to ensure rehabilitation process.

A validated questionnaire (short form 36/ SF-36) must be filled by all patients, to understand differences in return to a normal quality of life and to social activities between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* F; age 18 to 70
* American Society of Anesthesiologists (ASA) I e II;
* breast cancer ( DIN 2 e 3, o LIN 2 e 3 sec. Tavassoli) scheduled for nipple-sparing mastectomy, simple mastectomy, skin-sparing mastectomy, skin-reducing mastectomy c, lymphnode biopsy and axillary dissection;
* immediate sub-pectoral prosthetic reconstruction;
* signed informed consent.

Exclusion Criteria:

* preexisting pectoral, axillar, thoracic homolateral pain
* habitual opioid consumption;
* drug-alcoholics addiction ;
* ICU postoperative recovery;
* kidney failure (creatinin \> 2 g/dl, creatinin \<clearance 30 ml/h) and/or hepatic failure (cholinesterase \< 2000 UI);
* cardiac arrhythmias o;
* Epilepsy;
* Psychiatric, cognitive disorders, mental retardation;
* Coagulopathies (INR \> 2, activated partial thromboplastin time - aPTT\>44 sec);
* platelet count less than 100.000/mm3;
* BMI \> 30;
* Allergies to study drugs.
Cognitive Rehabilitation and Exposure-based Class for Compulsive Hoarding

The purpose of this protocol is to investigate the effectiveness of a manualized, 20-week group cognitive rehabilitation (CR) and exposure therapy (ET) course for compulsive hoarding. The overarching aim is to understand whether this course will decrease the core symptoms of hoarding and associated features.


Eligibility Criteria:
Inclusion Criteria:

* Include:

  * Individuals who exhibit subclinical and clinical levels of hoarding disorder, as determined by the SCID interview conducted at the screening assessment, will be eligible to participate in the study. Individuals may also display clinically relevant symptoms of hoarding as indicated by scores on the Hoarding Rating Scale Interview (HRS-I) and/or on the Saving Inventory-Revised (SIR).
  * Comorbid mood and anxiety disorders are permitted.
  * English-speaking
  * Pregnant women

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Individuals who are over the age of 85
* Individuals with cognitive or physical impairments that would interfere with their participation (e.g., Dementia, uncorrected hearing)
* Participants who have current or past psychotic symptoms or current or past alcohol/substance abuse/dependence may also be excluded.
* Participants may also be excluded if they are currently in other forms of psychotherapy.
* Participants may be excluded if they have had a change in psychotropic medications within three months of the baseline assessment/first class.
* Participants may be excluded if hoarding is not their primary diagnosis.
* Prisoners
Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants

Multiple Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ESK-001 in Healthy Participants

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

Eligibility Criteria:
Inclusion Criteria:

* Participant is a man or woman between the ages of 18 and 60years, inclusive, at the Screening Visit
* Participant is healthy as determined by medical history, physical examination, vital signs, and routine laboratory parameters
* Other inclusions as specified in the protocol

Exclusion Criteria:

* Participant has a prior exposure to ESK-001
* Participant has a history of hypersensitivity to any of the ingredients of ESK-001
* Other exclusions as specified in the protocol
Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability

The study hypothesis is that nurses and doctors can use a transcutaneously powered ultrasonic flow sensor to make repeatable and accurate hydrocephalic shunt flow measurements.

The study participants will align the flowmeter probe with a flow sensor hidden under a thick saline pad that simulates skin. A hidden pump will provide a known flow through the flow sensor as the participants make their measurements. Each participant will repeat these measurements over a period of weeks, and the data will tell whether operator skill influences flow measurement accuracy.

The study hypothesis is that a transcutaneously powered ultrasonic flow sensor for hydrocephalic shunts can be repeatedly and accurately read by medical personnel ranging from nurses to senior neurosurgeons.

The test will involve a prototype implantable hydrocephalic shunt flow sensor and readout electronics. The readout electronics use a pickup coil to transcutaneously operate the sensor once the coil is aligned with sensor's inductive coupling coils.

During the test, the shunt flow sensor will be hidden under a thick saline gel pad whose thickness approximates the skin thickness of an older pediatric patient. A syringe pump will provide a known flow rate through tubing connected to the sensor, but the study participants will not know the pump flow setting.

Three neurosurgeons and six floor nurses will perform this study. Each will use the Transonic flowmeter readout to align the pickup coils of the flowmeter with the hidden sensor to make flow measurements.

Each participant will repeat this measurement multiple times over non-consecutive days.

The recorded data will quantify measurement accuracy and repeatability between different operators, and will determine whether operator skill influences flow measurement accuracy.

Eligibility Criteria:
Inclusion Criteria:

* neurosurgeon
* nurse

Exclusion Criteria:

* none
Randomised Trial of Two Educational Intervention for Improving Evidence-based Practice Knowledge, Atttitudes and Practice

This pragmatic randomised controlled trial (RCT) used a two-group parallel design with matched-pair stratification by type (clinician/manager) and knowledge score. The trial aimed to: 1) determine whether an IE was more effective than a DE for improving EBP knowledge, skills and use at 12 weeks, and 2) to investigate the feasibility of conducting a RCT with occupational therapists in a public health setting. Occupational therapists employed by the Western Cape Department of Health (DOH) form,ed the study population(N=98). Fifty-eight consented to participate and were randomly allocated to either an interactive (IE) or a didactic (DE) educational intervention using coin tossing. Data was collected at baseline and 12 weeks The primary outcome was increased EBP knowledge at 12 weeks shown by an improved total knowledge score. Secondary outcomes were improved attitudes and behaviour. Data were collected at the health facilities where participants were employed. Raters for the audit were blinded but participants and the provider could not be blinded.

Thirty participants were allocated to receive the IE and 28 the DE. Twenty-five participants in the IE and 21 in the DE completed the trial and were included in the 12 week analysis. Results revealed no significant difference between the groups in the primary knowledge outcome at 12 weeks. Examination of within-group changes revealed significant improvements in knowledge in both groups (IE: T=4.0, p\<0.001; DE: T=12.0, p=0.002), but the IE also showed a significant increase in behaviour (T=64.5, p=0.044) and attitudes on one sub-scale (T=33.0, p=0.039). As the study was powered at 43%, it may have failed to detect significant differences at 12 weeks. Conducting a high-quality RCT was feasible and the risk of bias was assessed as low. The OTEBP trial adds strength to the existing evidence that both didactic and interactive educational interventions can improve knowledge, but it seems that interactive interventions may be more effective for changing behaviour. High-quality pragmatic trials can feasibly be conducted within the public health service


Eligibility Criteria:
Inclusion Criteria:

* Occupational therapists employed by the Western Cape Department of Health (DOH)
* Working at least 20 hours per week

Exclusion Criteria:

* Working at a distance of more than 1½ hours from Cape Town
* Therapists who would be leaving the DOH before December 2008 or taking leave during the time of the intervention
The Predicted Potential of Quantitative T Cell Repertoire(TCR) in Anti-PD-L1 Treatment in NSCLC Patients

This study is designed to evaluate the predicted potential of quantitative T cell repertoire (TCR) of T cell receptor chains using next-generation sequencing (NGS) in the treatment of the anti-programmed death-ligand 1 (PD-L1) antibody atezolizumab in participants with locally advanced or metastatic NSCLC who have progressed during or following a platinum-containing regimen. Treatment may continue until disease progression or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented, locally advanced or metastatic NSCLC
* Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens available or at least 12 unstained, freshly cut serial sections with associated pathology report that are evaluable for PD-L1 expression and epidermal growth factor receptor (EGFR) mutation status prior to enrollment, except for known sensitizing EGFR mutations in which case 10 unstained slides are required and there is no need for central testing of EGFR mutation status
* Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable, inoperable, or metastatic NSCLC, or disease recurrence within 6 months of treatment with a platinum-based adjuvant and/or neoadjuvant regimen or combined modality with curative intent
* Measurable disease per RECIST Version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy greater than or equal to (\>/=) 12 weeks
* Adequate hematologic and end organ function
* Agreement to remain abstinent or use contraceptive methods among women of childbearing potential or male partners of women of childbearing potential
* Recovery from all acute toxicities from previous therapy

Exclusion Criteria:

* Active or untreated central nervous system (CNS) metastases
* Spinal cord compression not definitively treated or not clinically stable
* Leptomeningeal disease
* Uncontrolled pleural or pericardial effusions or ascites requiring recurrent drainage
* Uncontrolled tumor-related pain
* Uncontrolled hypercalcemia
* Malignancies other than NSCLC within 5 years prior to randomization, except for those curatively treated with negligible risk of metastasis or death
* Pregnant or lactating women
* Significant cardiovascular, pulmonary, or autoimmune disease
* Severe infection or major surgery within 4 weeks, or antibiotic treatment within 2 weeks prior to randomization
* Prior treatment with or hypersensitivity to study drug(s) or related compounds
* Inability to discontinue strong cytochrome P450 (CYP) 3A4 inhibitors
* Prior allogeneic bone marrow or solid organ transplant
* Known PD-L1 expression status from other clinical studies
* Positive human immunodeficiency virus (HIV) or hepatitis B or C
* Receipt of a live attenuated vaccine within 4 weeks prior to randomization
* Treatment with systemic immunomodulators within 4 weeks or five half-lives (whichever is shorter) prior to randomization
* Treatment with systemic corticosteroids within 2 weeks prior to randomization