cyrilzakka/clinical-trials huggingface dataset:
Isometric Core Muscle Endurance in Healthy Active and Non-active Working Age Populations

Objectives: The purpose of this study was to investigate a possible correlation between core muscle endurance and participants' age in healthy adult population. Secondary purpose was to identify other dependent variables influencing isometric core muscle endurance (e.g. low back pain, physical activity, gender, body mass index).

Methods: 48 (35 females, 13 males) healthy adults (aged 21-66 years) performed 4 isometric core muscle endurance tests- Biering-Sorensen, McGill V-sit, right and left side plank. A correlation between core endurance and age, gender, lower back pain (LBP), physical activity level (PAL), and body mass index (BMI) was calculated.

This is the first study to investigate the core muscle endurance of different age groups and genders with all four endurance tests of the core.

Since strength and endurance are key to keeping healthy as we age and National Institute for Health and Care Excellence (NICE) and European guidelines advocate them, this study aims to look at the 3 main measurements of core endurance namely flexor, extensor and lateral muscles, and the possible correlations with age, PAL, existence of LBP, BMI and gender. Each participant performed 4 isometric core endurance tests in the same order- 1. Biering-Sorensen, 2.-3. side plank on both sides, and 4. McGill V-sit. All participants were tested by the same tester to reduce potential differences in procedure and testing error. The four tests were each measured using a stopwatch and documented in seconds. Each participant was told the time they had reached during testing to improve their motivation. Pain during testing was documented.

Based on the normative data of abdominal muscle endurance for young adults Null hypothesis (H0)- There is no significant difference in endurance tests for age, presence of LBP or PAL. Hypothesis (H1)- Any significant difference in endurance tests for age, presence of LBP or PAL are due to chance factors. This is a two-tailed hypothesis, as previous evidence shows conflicting results. Pearson's correlation and Independent T-test in SPSS (The Statistical Package for the Social Sciences) were used to confirm or reject the possible correlations between the core muscle endurance and age, LBP, PAL, gender, BMI, and participants' job.

Eligibility Criteria:
Inclusion Criteria:

* aged 20-70 (working age population)
* healthy
* active and non-active
* with or without non-specific lower back pain

Exclusion Criteria:

* all serious pathologies and diagnosis that could affect the ability to perform the tests safely including acute pain, neurological, musculoskeletal, cardiovascular diseases, spinal pathologies (e.g. spondylitis, acute herniated disc, cauda equina, hypertension, epilepsy, tumour, previous fracture or surgery in trunk, structured deformity, osteoporosis)
* sudden change in health
* personal reasons
* severe pain during testing
* competing in any sports higher than amateur level
Individualized Treatment of Patients With Advanced NSCLC: Potential Application for Circulating Tumor Cells (CTC) Molecular and Phenotypical Profiling

The purpose of this study is to determine the percentage of CTC-positive patients and total CTC numbers in patients with advanced Non Small Cell Lung Cancer .

The primary aim of the Project is to determine the percentage of CTC-positive patients and total CTC numbers in advanced NSCLC at baseline, before starting treatment.

To valuate CTC count modifications as an early predictor of response to treatment a prospective observational study will be conducted, consecutively enrolling 150 patients regardless of type or line of therapy, which will be reevaluated for disease status and CTC count depending on the type and schedule of treatment.

Furthermore, purified CTC will be obtained by automated platform and DNA sequencing will be performed to assess sensitizing mutations in advanced NSCLC patients. The EGFR mutations or EML4-ALK fusion gene detected in CTC will be compared with those reported for the tumor specimen using standard sequencing.

In parallel, the CTC count assay will be integrated with mAb targeting EGFR or EML4-ALK fusion gene, to test whether assaying the quote of EGFR-positive and ALK-positive CTC provides a more sensitive marker for rating pharmacodynamic effects in patients compared with total CTC counts.

Moreover, it was reported that NSCLC cells with EGFR mutations manifest activation of the PI3K (phosphatidylinositol 3-kinase)-AKT and MEK-ERK (extracellular signal-regulated kinase) signaling pathways under the control of EGFR, and exposure of such cells to EGFR-TKIs blocks signaling by both pathways and induces apoptosis 13. To evaluate whether live vs. apoptotic CTC changes under treatment may be used as predictor of tumor response, M30-positive CTC will be quantified as previously 8.

Data obtained with the CTC assay will be correlated with common prognostic factors.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old, males or females;
* Patients with NSCLC confirmed by histopathology or cytology;
* Life expectancy \> 6 months;
* Patients are voluntary to participate and sign the informed contents

Exclusion Criteria:

* Any condition which might hamper compliance to the schedule of assessments
Sensory Stimulation in Fibromyalgia

The purpose of this study is to investigate the effectiveness of low-intensity and prolonged vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.

The trial will last up to 8 weeks for each subject and includes:

Three weeks treatment 1 (sham or actual) Two week washout Three weeks treatment 2 (sham or actual) Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate, low intensity and long daily duration.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Rheum, 1990;33:160-172)
* Clinical symptoms are not a consequence of other medical disorder (although the presence of other disorders is not an exclusion criterion)
* Diagnoses established by an expert on fibromyalgia.
* Stable treatment of chronic use.
* Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent.

Exclusion Criteria:

* Generalized inflammatory articular or rheumatic disease.
* Heavily exercise for 12 hours prior to fMRI assessment
* Severe, non-stable medical, endocrinological or neurological disorder.
* Psychotic disorder or drug abuse.
Hyperpolarized Carbon C 13 Pyruvate Magnetic Resonance Spectroscopic Imaging in Predicting Treatment Response in Patients With Prostate Cancer

This phase II trial studies how well hyperpolarized carbon C 13 pyruvate magnetic resonance spectroscopic imaging works in predicting treatment response in patients with prostate cancer. Hyperpolarized carbon C 13 pyruvate magnetic resonance spectroscopic imaging may help to accurately predict how prostate cancer patients will respond to standard therapy (abiraterone and apalutamide).

PRIMARY OBJECTIVE:

I. To assess reproducibility of quantitative spectroscopic and imaging parameters in hyperpolarized 13-C pyruvate magnetic resonance spectroscopic imaging (MRSI), including key performance indicator (kpl), which assesses the rate of conversion of 13-C pyruvate to 13-C lactate in the tissue of interest, using a test-retest study design.

SECONDARY OBJECTIVE:

I. To provide initial assessment of the sensitivity and specificity of hyperpolarized 13-C-pyruvate MRSI performed pre-therapy for detecting high risk localized prostate cancer.

OUTLINE:

Patients receive hyperpolarized carbon C 13 pyruvate intravenously (IV) over 10-20 seconds and undergo MRSI over 2-3 minutes at 6 and 8 weeks.

After completion of study, patients are followed up at 1 day and then for up to 3 years.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven high risk prostate adenocarcinoma, or de novo metastatic previously untreated naive prostate cancer (patients who have initiated gonadotrophin releasing hormone \[Lhrh\] analog or antagonist within the past 4 weeks are eligible)
* Gleason \>= 8 OR Gleason 7 + \>= cT2b + prostate specific antigen (PSA) \> 10 ng/ml
* Prior prostate biopsy must have been performed at least 4 weeks prior

Exclusion Criteria:

* Contraindication to MRI
* Estimated glomerular filtration rate (eGFR) \< 30
* Allergy to gadavist intravenous contrast
* History of cardiac arrhythmia
* Since they do not get prostate cancer, women are excluded; thus, pregnancy is not an issue
Physiotherapy and Capsulitis

Multicenter randomised study, on parallel groups to compare recovery of functional amplitude following shoulder dilatation with auto rehabilitation in one group and physiotherapy in the other group.


Eligibility Criteria:
Inclusion Criteria:

* Primary idiopathic phase 2 capsulitis
* Diagnosis of capsulitis confirmed by shoulder dilatation
* Patients between 18 and 70 years of age
* Exclusion Criteria:
* Secondary capsulitis
* Shoulder pain of other etiology
* Cognitive disorders
* Patients less than 18 years, and more than 70 years of age
Study of Capsaicin Patch for the Management of Peripheral Neuropathic Pain

The efficacy and safety of the low concentration \[0.65% (50 µg/cm2) and 1.25% (100 µg/cm2)\] capsaicin patches and compared them to conventional 0.075% capsaicin cream and placebo patch in patients suffering from peripheral neuropathy


Eligibility Criteria:
Inclusion Criteria:

* patients who are 18 years of age or older aged having chronic peripheral neuropathy related with a diagnosis of either PHN or DPN
* patients with chronic peripheral neuropathic pain for more than 3 months with an 11-pointed Numeric Rating Scale (NRS) pain score ≥ 4
* patients with a diagnosis of PHN were eligible if at least 3 months had elapsed since shingles vesicle crusting
* patients with DPN and well controlled diabetes were asked to maintain a stable dose of oral hypoglycemic or insulin during the study period
* patients taking concomitant pain medications such as anticonvulsants, antidepressants, anxiolytics, and opioids including tramadol were required to maintain a stable dose for at least 4 weeks before the study enrollment
* any conservative therapies such as TENS, physical therapy, chiropractic, massage, biofeedback, or yoga were stopped at least 5 weeks before the enrollment
* women of childbearing age were required to have a negative pregnancy test and were to be willing to use an effective method of contraception for at least 28 days after the last exposure to study medication

Exclusion Criteria:

* diffusely distributed neuropathic pain resulting from spinal stenosis, postoperative origin, complex regional pain syndrome, or genetic neurological disease, or significant pain outside the target area
* significant pain of an etiology other than PHN or DNP
* other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or with investigational product administration or may interfere with compliance or the interpretation of study results andin the judgment of the investigator would make the subject inappropriate to participate in the study
* painful PHN areas located on the face or above the scalp hairline
* an implanted medical device for the treatment of neuropathic pain
* use of topically applied agents including capsaicin-containing products, a 5% lidocaine patch or similar products, local anesthetics, or steroids within the past 21 days
* hypersensitivity known to capsaicin; current use of any class 1 anti-arrhythmic drug; and uncontrolled diabetes mellitus or uncontrolled hypertension
* If patients have taken oral NSAID or COX2 Inhibitor, it should be stopped at least2 weeks before randomization; however acetaminophen for pain control was allowed up to 4g per day
A MRI Study of Visual and Motor Pathways in Premature Infants

Approximately 30,000 babies annually are born with extremely low birth weight (ELBW) in the US. These babies often have motor and/or visual problems when they grow up. It is very important to identify high risk ELBW infants as early as possible, so that the investigators can treat them earlier to prevent poor development. Neurological examination at early age is not good enough to identify high risk ELBW infants. One the other hand, some magnetic resonance imaging (MRI) methods such as diffusion tensor imaging (DTI) and resting state functional MRI (rfMRI) have shown great sensitivity to brain injury which may cause motor and visual problems. Therefore, the investigators propose to use DTI and rfMRI on ELBW infants at a very early age to predict long-term outcome and to identify infants who are at high risk of having motor and/or visual problems when they grow up.


Eligibility Criteria:
Inclusion Criteria:

* ELBW infants with birth weight 401-1000 g (gestational age \<30 weeks)

Exclusion Criteria:

* Complex congenital anomalies
* Central nervous system malformations,
* Chromosomal abnormalities, or hydrops fetalis
Performance and Safety Evaluation of an Intradermal Delivery Device

The purpose of this study is to evaluate whether an investigational vaccine delivery device (the ID adapter) can safely and precisely inject liquid into the intradermal layer of the skin.


Eligibility Criteria:
Inclusion Criteria:

* Female and male participants ages 18 to 55 years.
* Healthy enough to participate in the clinical trial per site investigator assessment.
* Healthy skin on the upper deltoid region of both arms.
* Able to provide signed informed consent and understand study procedures per ICH/GCP guidelines.
* Literate in English.
* Available by telephone 48 hours after the study visit.

Exclusion Criteria:

* Skin abnormalities on upper deltoid region of either arm (scars, rash, infection) or other skin conditions that would interfere with the ability to visualize an intradermal injection in the opinion of the investigator.
* Unable to understand the study purpose or procedures.
Long-term Monitoring of Growth and Development of Pediatric Patients Previously Treated With Everolimus

The primary objective of CRAD001M2305 was to report the long-term effects of everolimus treatment on height, weight and sexual development (using Tanner Stages) in children and adolescents with Tuberous Sclerosis Complex (TSC)-associated with Subependymal Giant Cell Astrocytoma (SEGA). The study monitored the growth and development of pediatric patients with TSC-associated SEGA, previously enrolled in CRAD001M2301 (NCT00789828) until they reach Tanner Stage V, or until age 16 for females or 17 for males whichever occurred first.

CRAD001M2305 was a prospective, multi-center phase IIIb/IV study. This study investigated if the physical and sexual development of pediatric patients was affected by previous or ongoing treatment with everolimus. The study monitored the growth and development of pediatric patients with TSC-associated SEGA, previously enrolled in CRAD001M2301(NCT00789828) until they reached Tanner Stage V, or until age 16 for females or 17 for males whichever occurred first. Continued treatment with everolimus was at investigator discretion and was not required for participation in CRAD001M2305. Growth (height, weight), and sexual development (Tanner Stages, sex hormone levels, age at menarche, thelarche (females) and adrenarche (males)), and brain development (assessed by TAND Checklist, dates of brain MRI) of patients participating in this long-term follow-up study was followed at annual visits to the site until patients achieve Tanner Stage V or age 16 (females), age 17 (males) whichever occurred first. Adverse events, concomitant medication, appearance of menarche, were monitored and data collected every 3 months ("3-monthly"). Unless clinically indicated these 3-monthly visits were performed per telephone.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric female patients who were on study treatment in study \[CRAD001M2301\] within the past 6 months and have not reached Tanner Stage V or age 16 at the time of completion of \[CRAD001M2301\] or
* Pediatric male patients who were on study treatment in study \[CRAD001M2301\] within the past 6 months and have not reached Tanner Stage V or age 17 at the time of completion of \[CRAD001M2301\]
* Written informed consent according to local guidelines

Exclusion Criteria:

* Pediatric female patients who were on study treatment in CRAD001M2301 and have not reached Tanner Stage V but are within 3 month of turning age 16 or
* Pediatric male patients who were on study treatment in CRAD001M2301 and have not reached Tanner Stage V but are within 3 months of turning age 17
* Any patient who was pregnant prior to start of CRAD001M2305
Standard IV Cannula Aspiration (SIVCA): A Novel, Efficient and Minimally Invasive Testicular Sperm Aspiration Technique

Study question:

Can enough testicular tissue be aspirated for sperm retrieval in non-obstructive azoospermia (NOA), using a wide bore 14-G Standard IV cannula in comparison to micro-TESE?

Summary answer:

Standard IV cannula Aspiration (SIVCA) can yield an ample amount of testicular tissue sufficient for sperm retrieval through a single puncture site on the scrotum.

What is known already:

The current conventional method of testicular sperm aspiration is fine needle aspiration (FNA). FNA has the advantage of being a cost-effective and minimally invasive procedure compared to open testicular sperm extraction (TESE). But FNA with its conventional 23-G needle may not always yield enough testicular tissue for sperm retrieval. Furthermore, FNA may require multiple punctures on the scrotum to retrieve enough tissues from different areas of the testis.

Study design, size, duration:

A 24 months prospective cohort study conducted at a specialized IVF center. A total of 130 men aged from 22 to 53 years old (35.03 +/- 9.04) with NOA and normal testicular volume (≥ 12ml) were enrolled in the study. The men had testicular biopsies taken at the day of their partners' ovum pick-up. On each patient, the testes were randomized to undergo SIVCA on one testis followed by micro-TESE on the contralateral testis.

Participants/materials, setting, methods:

After local anesthesia, a wide bore 14-G standard IV cannula was introduced near the lower pole of the testis. The needle was withdrawn and the catheter introduced into the testicular tissue. A 20-ml syringe was secured to the catheter and constant negative pressure applied and secured with a clamp. Back and forth motions were performed covering as many areas of the testis as possible. Micro-TESE was then performed on the contralateral testis.Sperm retrieval rates (SRR) will be compared between the two techniques using McNemar χ2 test. A P-value of less than 0.05 was considered to be statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Non Obstructive Azoospermia
* Normal Sized testes (Above 12ml in volume)

Exclusion Criteria:

* Obstructive Azoospermia
* Small sized testes
Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)

The primary objective is to evaluate the safety and feasibility of using M118 as an anticoagulant in the target population of subjects with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI).

The secondary objectives are to evaluate the effect of M118 on procedural indices including procedure success, abrupt closure, post-procedure TIMI flow, and catheter thrombus.

Substudy Primary Objective The primary objective of the substudy is to characterize the pharmacokinetic and pharmacodynamic profile of M118 among subjects with stable coronary artery disease undergoing elective PCI.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 19 years
* Ability to give informed consent
* Documented stable CAD with a significant lesion in a native coronary artery amenable to PCI with one stent
* Planned single vessel intervention

Exclusion Criteria:

* Myocardial infarction or unstable angina within the prior 7 days
* Target lesion is a chronic total occlusion (present for longer than 3 months)
* Target lesion with angiographically visible thrombus or in-stent thrombosis
* Target lesion is in a bypass graft
* Planned use of a GP IIb/IIIa inhibitor or planned use of atherectomy including directional, rotational, or laser
* Known allergies or sensitivities to heparin, pork, or pork-containing products
* History of HIT
* Hemodynamic instability
* Stroke or Transient Ischemic Attack (TIA) in the prior 3 months
* Active bleeding or bleeding diathesis
* Trauma or major surgery in the preceding month or planned surgery or PCI within the 30 days after the index PCI
* Suspected aortic dissection
* Receiving oral anticoagulation therapy
* Receipt of LMWH or of UFH (except for that used during the diagnostic portion of the index procedure) within the prior 7 days
* ACT \> 200 prior to study drug administration
* Severe, untreated hypertension at the time of the index PCI procedure (systolic blood pressure of \> 180 mm Hg, diastolic blood pressure \> 90 mm Hg)
* Hemoglobin level of less than 10.0 g/dl or a hematocrit below 30%
* Platelet count of less than 100,000 per cubic millimeter or more than 600,000 per cubic millimeter
* Creatinine clearance \< 30 mL/min
* Any malignancy within the prior 5 years with the exception of non-melanoma skin cancers
* Prior enrollment in EMINENCE trial or currently receiving other experimental therapy
* Pregnant or lactating if subject is female

Substudy:

Inclusion:

* Ability to give informed consent
* Participation in the main study protocol

Exclusion:

-Inability to provide the blood specimens required by the substudy protocol
A Study of Combination Therapy With Amivantamab and Docetaxel in Participants With Metastatic Non-small Cell Lung Cancer

The purpose of this study is to identify the recommended Phase 2 (combination) dose (RP2CD) of the amivantamab and docetaxel combination therapy in participants with metastatic non-small cell lung cancer (NSCLC) in Phase 1 (combination dose selection); and to evaluate the antitumor effect of the combination at the selected RP2CD in participants with NSCLC without oncogenic driver mutations with disease progression on platinum-based chemotherapy and immune checkpoint inhibitor, in the Phase 2 (expansion).


Eligibility Criteria:
Inclusion Criteria:

* Participant must have histologically or cytologically confirmed NSCLC and must have metastatic NSCLC at the time of enrollment
* Participant must have at least 1 measurable lesion, according to RECIST v1.1, that has not been previously irradiated
* May have brain metastases only if previously definitively treated, and participant is clinically stable and asymptomatic for \>2 weeks and is off or receiving low-dose corticosteroid treatment (\<=10 mg prednisone or equivalent) for at least 2 weeks prior to start of study treatment
* May have a prior malignancy (other than the disease under study) if the natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)
* Have an ECOG performance status of 0 or 1

Exclusion Criteria:

* For Phase 2 only: Participant has known oncogenic driver mutations (EGFR, MET, HER2, ALK, ROS1, NTRK, BRAF, RET, or KRAS) as detected by local testing or by central ctDNA testing
* Participant has received radiotherapy for palliative purposes less than 14 days prior to the first dose of study treatment
* Participant has: a.(Or has a history of) leptomeningeal disease (carcinomatous meningitis); b. Spinal cord compression not definitively treated with surgery or radiation.
* Medical history of (non-infectious) ILD/pneumonitis, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening- Participant has history of any significant drug allergy (such as anaphylaxis, hepatotoxicity, or immune-mediated thrombocytopenia or anemia) or has known allergies, hypersensitivity, or intolerance to: a. amivantamab or amivantamab excipients (refer to the amivantamab IB); b.docetaxel, docetaxel excipients or to other drugs formulated with polysorbate and paclitaxel