cyrilzakka/clinical-trials huggingface dataset:
Effects of Neurodynamics on Lower Extremity Spasticity - a Study in Chronic Stroke

Post-stroke spasticity in the lower extremity affects balance and gait, leading to decreased mobility and functional independence. Therefore, effective intervention for reducing spasticity is crucial in stroke rehabilitation. Recently, neurodynamics, though originally designed for pain management in orthopedic patients, has also been applied for treating spasticity in patients with neurological disorders. However, previous studies focused mainly on treating the upper extremity spasticity, but not on lower extremity spasticity, and not on possible neurophysiological changes. The present study aims to investigate the immediate effects of neurodynamics in reducing lower limb spasticity and neurophysiological changes in people with chronic stroke.

Sample size calculation: There was no reference for the effect size of neurodymanics on reducing lower extremity spasticity, and the effect size of neurodynamics treatment for improving knee range of motion was between 0.89 to 2.55. We set the effect size of 0.6 (moderate effect size) with an alpha level of 5%, power at 80%, and a paired t-test model to calculate the sample size.

Statistical analysis: Paired t-test will be used for within condition (experimental or control condition) comparisons. The change values between pre and post in each condition will be calculated and compared by paired t-test for between condition comparisons. The significance is set at p\< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of first-ever stroke with unilateral lesion for more than 6 months
* demonstrating calf muscle spasticity as indicated by modified Ashworth scale equal to or greater than 1
* with passive ROM of ankle dorsiflexion at least to neutral position (defined as 0°)
* ability to walk at least 10m independently without a walking device or ankle-foot orthosis (AFO)
* sufficient cognition (mini-mental state examination, MMSE score of 24 or higher)

Exclusion Criteria:

* contraindications to nerve conduction tests
* other orthopedic and neurological disorders interfering participating in the study
Profiling the Endocannabinoid Response to Hedonic Eating

Study into the endocannabinoid response to consuming a palatable versus a neutral food.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (self-report)
* Dutch
* Evaluating one of the used foods as palatable
* Evaluating one of the used foods as neutral
* Hb value between 8.1 and 11.0 mmol/L at screening

Exclusion Criteria:

* restraint eating
* lack of appetite
* difficulties eating/swallowing
* endocrine disorders
* energy restricted diet two months prior to study
* weight change \> 5 kg in two months prior to study
* stomach or bowel disease
* taste or smell disorders (self-report)
* not consuming foods used in the study
* smoking \> 1 cigarette per day
* drinking \> 21 units alcohol per week
Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With ARDS

Evaluate the safety, tolerability, efficacy and pharmacodynamics\&pharmacokinetic properties of CT303 in patients with ARDS.

This study is a multi-center, open-label, dose-escalation and dose-finding phase 1 clinical trial.

The primary purpose is to evaluate the safety and tolerability of CT303 and the Secondary purpose is to evaluate the efficacy of CT303 in patients with ARDS. And the exploratory purpose is to evaluate pharmacodynamics properties pharmacokinetic properties of CT303 in patients with ARDS.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 19 years old
* Patients who meet the ARDS criteria according to the Berline definition

  1. within 1 week of a known clinical insult or new or worsening respiratory symtoms
  2. Bilateral opacities not fully explained by effusions, loar/lung collapse, or nodules
  3. Respiratory failure not fully explained by cardiac failure or fluid overload
  4. oxygenation corresponding to mild, moderate, severe
* Patients requiring positive pressure ventilation using an endotracheal tube
* Patients or legal representative signed Informed consent form

Exclusion Criteria:

* Greater than 96 hours since first meeting ARDS criteria
* Patients who was previously administered mesenchymal stem cell therapy products or other cell therapy products
* Patients with the following medical history or comorbid condition

  1. medical history

     1. Patients who had an organ transplant or bone-marrow transplantation
     2. Patients who had a pneumonectomy
     3. a maligant tumor within 5 years
     4. a deep vein thrombosis or pulmonary embolism with in 6 months
     5. a trauma within 7 days
  2. comorbid condition

     1. Patients with AST or ALT exceeding 5 times the upper limit of the normal range
     2. eGFR ≤ 29mL/min or Patients requiring continuous renal replacement therapy
     3. severe chronic respiratory disease
     4. WHO functional assessment class III/IV pulmonary hypertension
     5. Severe cardiac insufficiency
     6. QTc \> 480msec
     7. chronic underlying diseases
* viral hepatitis type B or type C, or positive HIV test
* Patients using extracorporeal life support devices or high-frequency oscillatory ventilation
* Moribund patients expected to die within 48 hours
* Patients who refuse or are likely to refuse life-sustaining treatment
* Fertile women or men who disagree a continence and a contraception
* Patients with a history of hypersensitivity reaction
* Patients participating in clinical trials within 4 weeks
* Patients determined by the investigator to be inappropriate to participate in this clinical trial
Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers

The purpose of this study is to test whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers.

This single site, open label, two arm randomized control trial aims to evaluate whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers. Optimal turning procedures will be obtained with the use of a patient monitoring system (Leaf Healthcare, Inc.) and compared to standard preventative care practices.

Sensors were placed on all participants as they were admitted to ICU. A nurse's user dashboard was turned on for participants in the Optimal Turning Group, but was not turned on for participants in the Standard Care group.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years of age)
* Admission to Intensive Care Unit

Exclusion Criteria:

* Children (\<18 years of age)
* Adhesive allergy
* Physical limitation for sensor application
Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients

The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 years of age with type 1 or type 2 diabetes.
* Subjects with peripheral occlusive arterial disease (PAOD) and a neuropathy disability score (NDS) of \>3

Exclusion Criteria:

* Subjects who have undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Subjects with an ulcer grading of 0 or 3 and staging of A, B or D according to the University of Texas wound classification system.
* Subjects with a known bleeding disorder or evidence of active bleeding.
Impact Evaluation of Incisional Hernia on Muscular and Postural Function

Purpose of study is to assess perioperative functional parameters of the anterior abdominal wall muscles and postural control status in patients with large and giant incisional hernias in a controlled diagnostic study.

The study involved 95 patients (100% completed) with a large or giant incisional hernia of the anterior abdominal wall. The participants were divided into three groups by type of hernia repair: bridged hernia repair, Rives-Stoppa procedure, or TAR technique. Perioperative functional parameters of the anterior abdominal wall muscles were assessed by tension dynamometry. The postural balance assessments were made by raster photostereography.


Eligibility Criteria:
Inclusion Criteria:

* big and giant incisional hernia
* hernia without recurrence
* age 18-75

Exclusion Criteria:

* acute infection diseases
* cancer
* orthopedic diseases
* terminal status
* BMI\>39,9
Music After Stroke To Enhance Rehabilitation

Music that is familiar and preferred by patients has been shown to heighten neuroplasticity and can mitigate these disabilities. Therefore, this study seeks to explore the effect of providing patient preferred music to patients in the very early post stroke period (within 24 hours of a left cerebral artery stroke \[LMCA\]event) as a complementary modality to usual stroke care.

Aim I. The primary aim of MASTER is to identify whether a potential relationship exists between an intervention of participant preferred music, when initiated within the first 24 hours following a left middle cerebral artery stroke, and a reduction in the following disabilities: Expressive aphasia, right hand functional deficit and post stroke depression. This aim will serve to address the first research hypothesis and address the relationship between These disabilities are well known sequalae among patients diagnosed with the most common form of stroke, a LMCA stroke. Participant preferred music within the first 24 hours following a LMCA stroke and a reduction in: Expressive aphasia, right hand functional deficit and post stroke depression, as these disabilities are well known sequalae among LMCA stroke patients.

Aim II. The second aim of MASTER is to identify if a relationship exists between an intervention of audible books, when initiated within the first 24 hours following a LMCA stroke, and a reduction in the following disabilities: Expressive aphasia, right hand functional deficit and post stroke depression.

Sufficient evidence exists to suggest that although listening to books stimulates cognitive function, the effect of melody and participant engagement in music is far superior to listening to words alone as the inherent rhythmicity of patient-favored music has been shown to strengthen synchronous neuronal connectivity, by modulating dopamine and inducing fine grained neuroanatomical changes in a recovering brain.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of LMCA stroke within prior 24 hours
* Not identified as critically ill
* Glascow Coma Scale \> 8 at time of consent
* Resident of a home with a land line or cell phone
* Able to speak in English or Spanish prior to stroke event
* Presence of expressive aphasia at time of enrollment.

Exclusion Criteria:

* Stroke diagnosis other than LMCA territory stroke
* Unable to provide consent by patient or legally accountable person acting on behalf of the patient (healthcare proxy, healthcare power of attorney), Patient/ representative
* Does not speak English or Spanish prior to stroke event
* Have a diagnosis of end stage cancer, or other medical conditions that dramatically increase a risk of mortality within one year
* Any pre-existing communication disorder (including dementia)
* Patients that are deemed critically ill will not be included
Study of Out of Specification for Tisagenlecleucel

This study will evaluate the safety of tisagenlecleucel that is out of specification( OOS) for release as commercial product. Specifically, this study will evaluate the safety of CTL019 in the patients treated within the approved label by Japan Health Authority in Part 2. Only for Part 1, in addition to safety, key efficacy of CTL019 will also be evaluated.

This is a single-arm, open-label, multicenter, interventional Phase IIIb study in pediatric/young adult patients with relapsed/refractory (r/r) B-cell acute lymphoblastic leukemia (pALL) and adult patients with r/r large B-cell lymphoma (LBCL) including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B cell lymphoma, and DLBCL arising from follicular lymphoma for Part 1 and and r/r ALL and r/r non-Hodgkin's lymphomas (NHL) for Part 2

Patients whose final manufactured tisagenlecleucel patient-specific batch does not meet the approved local commercial release specifications are eligible for inclusion. Each case will be individually assessed and approved by the Novartis manufacturing facility and the Novartis global medical team (including Patient Safety). Following a single infusion of CTL019, the patient will be followed for 3 months for Part 1, and 1 day for Part 2.

Eligibility Criteria:
Key inclusion criteria:

* Signed informed consent/assent must be obtained for this study prior to participation in the study.
* Patients for whom the final manufactured tisagenlecleucel product does not meet the commercial release specifications.
* Not excluded from commercial manufacturing under the Health Authority-approved tisagenlecleucel prescribing information for their respective country/region.
* OOS material has not been deemed to pose an undue safety risk to the patient.
* Patient is suffering from a serious or life-threatening disease or condition.
* Repeat leukapheresis is not clinically appropriate per the investigator assessment.

Key exclusion criteria:

For part 1, patients meeting any of the following criteria are not eligible for inclusion in this study:

* Human immunodeficience virus (HIV) positive patients.
* Patients with active replication of Hepatitis B virus (HBV) or Hepatitis C virus (HCV).
* Patients with primary central nervous system (CNS) lymphoma.
* History of hypersensitivity to any drugs or metabolites of similar chemical classes as tisagenlecleucel.
* Uncontrolled active infection or inflammation.
* Any medical condition identified by the investigator that may impact the assessment of the safety or efficacy outcomes in relation to study treatment.
* Pregnant or nursing (lactating) women. For part 2, exclusion criteria are not set; however, administration should be performed in accordance with the latest versions of the package insert of CTL019.
A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

This is a phase 3, open-label, randomized, multi-center study assessing the efficacy and safety of DZD9008 versus platinum-based doublet chemotherapy in participants with locally advanced or metastatic NSCLC with EGFR Exon20ins mutation, who are newly diagnosed or have not received prior systemic therapy in advanced stage.

Primary objective of this study is to assess the efficacy of DZD9008 versus platinum-based doublet chemotherapy using by BICR-assessed PFS per RECIST 1.1 as primary endpoint. Approximately 320 participants are estimated to be randomized into the study. Participants enrolled will be randomized to DZD9008 or platinum-based doublet chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without).


Eligibility Criteria:
Inclusion Criteria:

1. Aged at least 18 years old (or per local regulatory/IRB requirement).
2. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy.
3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
4. At least 1 measurable lesion per RECIST Version 1.1
5. Life expectancy ≥ 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Adequate organ and hematologic function

Exclusion Criteria:

1. Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
2. Spinal cord compression or leptomeningeal metastasis.
3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
4. History of stroke or intracranial hemorrhage within 6 months before randomization.
5. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses (i.e., hemophilia and Von Willebrand disease).
The Assessment of POCD After TURBT Under Spinal Anesthesia

This study evaluates the influence of premedication on cognitive functions in patients undergoing transurethral resection of bladder tumor under spinal anesthesia. The aims of premedication are anxiolysis, analgesia and the reduction of perioperative risk among the patients with comorbidities. The patients will be randomly allocated to receive premedication either with opioid solely or with benzodiazepine combined with opioid. The anesthetic technique is standardized.

Trans-urethral resection of bladder tumor (TURBT) is the basic endoscopic procedure for management of bladder cancer and if there are no contraindications, it is performed under spinal anesthesia. The condition usually occurs among elderly patients, every 9 of 10 is older than 55 years. At this age the postoperative cognitive dysfunction (POCD) is a common complication as the risk increases with age. There are some studies indicating that using benzodiazepines during the perioperative period can also increase the number of registered POCD in patients undergoing anesthesia. Postoperative cognitive dysfunction (POCD) occurs after operations under regional and general anesthesia as well. The study was planed to evaluate the risk of POCD among urological patients and to asses whether combining benzodiazepines with opioids for premedication increases this risk.

The participants after giving the informed consent can participate in the study. The Beck Depression Inventory is performed to rule out the patients with depression. The cognitive functions are tested with Montreal Cognitive Assessment before the surgery and subsequently in the first 24 hours after surgery, three weeks later (while patients come back to receive histopathological examination), and finally six months after surgery (during control cystoscopy).

During anesthesia, the patients will be randomly allocated to receive premedication either with opioid solely or with benzodiazepine combined with opioid. The anesthetic technique is standardized. If the premedication is needed before the surgery the hydroxyzine will be administrated.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* transurethral resection of the bladder tumor
* spinal anesthesia

Exclusion Criteria:

Exclusion Criteria:

* patients' refusal
* contraindications for spinal anesthesia
* skin lesions at injection site
* depression
Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With PCV10

The aim of the study are to assess the persistence of immunity against vaccine serotypes (VSTs) and vaccine-related serotypes in PCV10 vaccinated children in Finland.

The primary objective is to evaluate the long-term persistence of humoral immunity to vaccine-related pneumococcal serotypes after vaccination with PCV10.

Eligibility Criteria:
Inclusion Criteria:

* Completed PCV10 vaccination with 3 or 4 doses (2+1 or 3+1 schedule) before blood sampling at age of 13 months
* Age at sample collection 13 months, 2 years or 3 years
* PCV10 vaccination received 2-6 weeks before sample collection at the age of 1 year
* Informed consent obtained covering the planned analyses

Exclusion Criteria:

* PCV13 or PPV23 dose received
* Informed consent withdrawn
Intrawound Administration of Vancomycin in TKA

The purpose of this study is to determine the intra-articular and serum levels of vancomycin over the first 24 hours postoperatively after intra-articular administration of a standard dose of vancomycin in primary total knee arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 50 and 80
2. Total knee arthroplasty for primary osteoarthritis. Primary diagnosis of knee osteoarthritis

Exclusion Criteria:

1. Diminished mental capacity
2. Vancomycin allergy
3. Chronic kidney disease stage III and stage IV
Added Value of SVC Isolation in Patients With Pulmonary Vein Reconnection Undergoing Repeat Ablation for Recurrent Paroxysmal AF

Redo procedures after CLOSE-guided pulmonary vein isolation (PVI) for atrial fibrillation (AF) occur in 10% of patients. In case of pulmonary vein (PV) reconnection, electrophysiologists may re-isolate the pulmonary veins with or without the ablation of other commonly known PV-triggers. The superior vena cava (SVC) is one of the most common non PV-triggers for atrial tachyarrhythmias. SVC electrical isolation can be reached by circular radiofrequency-ablation under close monitoring of the phrenic nerve. However, it's added value remains unclear.

With this prospective, randomized, controlled, unblinded, mono-center study, the investigators aim to evaluate the 1-year recurrence rate in paroxysmal AF patients with reconnected pulmonary veins during a redo ablation with PV re-isolation or PV re-isolation with SVC isolation.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients scheduled for a repeat ablation of PAF after a previous PVI
* PV reconnection (in ≥1 PV's) found during procedure at the time of randomization

Exclusion Criteria:

* Patients with persistent AF
* Patients with durable PVI (no PVR)
* Previous ablation with isolation of the SVC, roofline, mitral line or previous vein of Marshal ethanol infusion
* Left atrial thrombus. LAA thrombus can be determined by preprocedural imaging: CT, TEE or MRI.
* Left ventricular ejection fraction \<35%.
* Cardiac surgery within the previous 90 days.
* Expecting cardiac transplantation or other cardiac surgery within 180 days.
* Coronary PTCA/stenting within the previous 90 days or myocardial infarction within the previous 60 days.
* Documented history of a thromboembolic event within the previous 90 days.
* Diagnosed atrial myxoma.
* Significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms.
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
* Women who are pregnant or who plan to become pregnant between signing the informed consent form and the index ablation.
* Acute illness or active infection at time of index procedure
* Advanced renal insufficiency
* Unstable angina.
* History of blood clotting or bleeding abnormalities.
* Contraindication to anticoagulation.
* Life expectancy less than 1 year.
* Presence of a condition that precludes vascular access.
* INR greater than 3.5 within 24 hours of procedure - for patients taking warfarin.
* Patient cannot be removed from antiarrhythmic drugs for reasons other than AF.
* Unwilling or unable to provide informed consent.
Shave Margins in Breast Conservation Therapy

The investigators propose a randomized controlled superiority trial of standard breast-conserving surgery (BCS) versus BCS with cavity shave margins (CSM). The main objectives of this trial will be to evaluate prospectively the impact of routine standardized CSM on margin status following primary surgery for early stage breast cancer (Stage 0 - II), on post-operative patient satisfaction and cosmetic outcomes, and on general intraoperative time and operative costs. A parallel group format will be implemented to compare this modified surgical therapy - BCS with CSM - with BCS alone, which is the current standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, biopsy-proven stage 0-II breast cancer.
* Planning to undergo breast-conserving surgery.
* At least 18 years of age and no more than 85 years of age.
* Female.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Prior surgical treatment for this diagnosis.
* Undergone neoadjuvant chemotherapy.
* History of prior chest radiation therapy.
* Known metastatic disease.
* Pregnant.
* Preference for mastectomy instead of breast-conserving surgery.
* History of ipsilateral breast cancer.
* Goggle assessment substudy: Iodine or seafood allergies.