cyrilzakka/clinical-trials huggingface dataset:
Lumber Spine Mobilization and Spinal Traction on Lumber Radiculopathy.

Lumber radiculopathy, also known as sciatica, is a condition that causes pain in the lower back and legs due to irritation or compression of the spinal nerves. group between 20 and 50 years old. This study will explore the effects of lumbar spine mobilization with leg movement and spinal traction with and without belt in patients with pain and functional limitations due to lumbar radiculopathy. A randomized control trial will be conducted at Atta Jaspal Hospital and Trauma Center through convenient sampling technique on 44 patients, which will be allocated through simple random sampling through sealed opaque envelopes into groups A and B. Group A will be treated with SMWLM, conventional electrotherapy, and traction without a belt, and Group B will be treated with SMWL, conventional electrotherapy, and lumbar traction with a belt. A pretreatment baseline will be set for pain, ROM, and disability at the lumbar spine by using the NPRS, inclinometer, and ODI questioner. Follow-up will be conducted after 4 weeks of post-treatment sessions. The intensity of pain, range of motion, and disability index will be evaluated using the NPRS, inclinometer, and ODI questionnaire. The data will be analyzed using SPSS software version 26. The conclusion of the study will be based on either accepting or rejecting the null and alternate hypotheses.

Low back pain (LBP) is one of the primary causes of disability worldwide. Most people-between 50% and 80%-experience LBP at some point in their life. It limits the ability to perform daily activities, such as walking, standing, or lifting objects. It can also lead to decreased mobility, reduced work productivity, and increased healthcare costs. Radiating pain is commonly caused by lumbar intervertebral disk abnormalities, which are linked with nerve root irritation and affect 3% to 10% of people with generalized low back pain. Sciatica, another name for lumbar radiculopathy, is a disorder marked by pain, weakness, numbness, or tingling sensations that radiate down the lower back along a nerve root, frequently into the buttock, thigh, and lower leg. One or more lumbar nerve roots are usually compressed, irritated, or inflamed as a reason.

Eligibility Criteria:
Inclusion Criteria:

* Age of 16-50 years of both sexes, unilateral radiculopathy in the distribution of specific nerve with positive straight leg raise (SLR).
* Mild to moderate disability and pain on a scale of NPRS \< 7, minimum chronicity of 1 month, and maximum 6 months

Exclusion Criteria:

* Patients with previous spinal surgery'
* Any bony or soft tissue systemic disease.
* Patients with diagnosed case of co morbidities such as malignancies , RA or fractures that causes bilateral leg pain
Registry for Molecular Testing, Treatment and Outcome of Patients With Solid Tumors Harboring a NTRK Gene Fusion

The objective of this registry is to analyze treatment reality and outcome of patients with locally advanced or metastatic solid tumors harboring a fusion of NTRK1, NTRK2 or NTRK3

The REALTRK registry will provide data on treatment reality of patients with locally advanced or metastatic solid tumors harboring NTRK1, NTRK2 or NTRK3 gene fusions, thereby generating real world evidence. It will identify factors that influence treatment decisions after receiving the diagnosis of a NTRK (Neurotrophic Tyrosine Receptor Kinase) fusion-positive cancer. All treatment lines administered before and after the molecular diagnosis of a NTRK fusion-positive cancer, irrespective of the type of antineoplastic treatment, will be documented. Data will be assessed at least 36 months per patient (i.e. until 36 months after inclusion of the last patient in the study). This approach will allow a description of TRK fusion protein-targeted therapies and other therapy strategies regarding effectiveness and disease-related symptomology within the limitations of non-randomized studies in terms of comparative analyses. Intra-individual and inter-individual comparisons (for the latter, provided that a sufficient number of patients with a NTRK fusion-positive cancer are not treated with a TRK inhibitor) could be performed.

The associated biomarker profiling module of the REALTRK registry will aim to set up a decentralized biobank for future research on molecular alterations.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic solid tumor with a documented NTRK gene fusion, based on a validated assay (according to current ESMO recommendations), or the provision of tumor material for central retesting
* Molecular pathology or molecular diagnostics report with details on NTRK gene fusion testing must be available
* Aged ≥ 18 years
* Signed and dated informed consent form (ICF) (only if patient is alive at time of data entry into the project; not applicable for inclusion of deceased patients' data)

Exclusion Criteria:

* Treatment with a TRK inhibitor prior to Sept 19th, 2019 (Germany) or May 28th, 2020 (Switzerland)
* Participation in a clinical trial with a TRK inhibitor before or at enrolment (liv-ing patients) or before inclusion (deceased patients)
* Deceased patients who have explicitly contradicted further use of data
Usefulness of Light Wand-guided Insertion of Flexible Reinforced Laryngeal Mask Airway

Flexible LMA (Laryngeal mask airway) is very useful for variable situation but it is hard to insert in correct position because of it's flexible structure. Especially in classical way of manual LMA insertion, when the index finger could not guide the flexible LMA to the optimal position, we could not guarantee the correct position of the LMA. Therefore several studies have been investigated to improve this.

The light wand is a kind of stylet which have a light on the tip. Recently some studies demonstrated the usefulness of the light wand which could be used for indicating correct position of the LMA. We hypothesised there will be two advantages if the light wand is used as a stylet of the flexible LMA. First the stylet could support the mildness of the flexible LMA, and second the lightness could confirm the correct position of the flexible LMA.


Eligibility Criteria:
Inclusion Criteria:

* The patient need general anesthesia using LMA and belonged to the ASA(American society of Anesthesiologist) class I or II

Exclusion Criteria:

* The patient who has URI(upper respiratory infection) symptom within 14 days or
* The patient's BMI(body mass index) exceeds 35 kg/m2
* The patient has severe GERD(gastroesophageal reflux disease) or hiatus hernia
* The patient who has any contraindication for LMA insertion
Ketamine Sedation in Mechanically Ventilated Patients

* Adequate sedation is of paramount importance to avoid stress and pain in mechanically ventilated patients. It is usually achieved by infusing sedatives (benzodiazepine) and analgesic (opiate) drugs.
* This combined sedation may not be sufficient in some instances.
* The aim of this study is to evaluate whether addition of a third substance, ketamine, allows the achievement of better sedation and avoids the use of neuromuscular blocking agents.

* Mechanical ventilation is widely used in critically ill patients. Sedation is used in most instances to alleviate symptoms of pain and distress. It usually consists of an association of opiates and benzodiazepines.
* In some instances, pain and agitation persist despite this combined sedation regimen. In such cases, the clinicians have the choice between increasing dosage of these 2 substances which may increase their adverse effects (mainly hypotension) and/or adding a neuromuscular blocking agent which is not devoid of adverse effects (mainly the onset of neuromyopathy of critical illness).
* This study will assess the safety, efficacy and cost-effectiveness of adding ketamine, a well known anesthetic agent, to a combination of midazolam and sufentanil when this combination is not sufficient to reach acceptable sedation target.

Eligibility Criteria:
Inclusion Criteria:

* Mechanically ventilated patients who receive adequate dosing of sedative agents (midazolam \> 0.15 mg/kg/h plus sufentanil \> 0.3 mcg/kg/h)
* Persistence of agitation indicating that sedation is not appropriate, as assessed by validated sedation scales (Harris scare; Motor Activity Assessment scale).

Exclusion Criteria:

* Pregnancy
* Patient who already receives neuromuscular blocking agents
Multicenter, Prospective Study for Urinary Exosomal Biomarkers of Kidney Allograft Tubulointerstitial Fibrosis

The investigators aim to identify urinary exosomal biomarkers that represent the extent of graft fibrosis from deceased donor kidney transplantation. Urinary samples will be collected from deceased kidney donors at the time of procurement and zero-day kidney graft biopsy will be performed at the time of transplant. The association between urinary exosomes and the degree of graft fibrosis will be analyzed to identify biomarkers that represent fibrosis. The correlation between these biomarkers and graft long term outcomes will be investigated.

Interstitial fibrosis and tubular atrophy (IFTA), previously known as chronic allograft nephropathy (CAN), is diagnosed by pathologic changes involving all parts of the renal parenchyma and is one of the factors impacting graft survival and outcome. Currently, there is no standard to predict allograft fibrosis status at the time of procurement. Noninvasive biomarkers are necessary to monitor allograft status and to predict long-term outcomes.

The investigators aim to conduct a multicenter prospective study to identify urinary exosomal biomarkers that represent the extent of graft fibrosis from deceased donor kidney transplantation. Urinary samples will be collected from deceased kidney donors at the time of procurement and zero-day kidney graft biopsy will be performed at the time of transplant. The zero-day biopsy tissue will be stained with Masson's Trichrome staining, Collagen I, III, IV immunostaining to evaluate the degree of fibrosis. Also, by ultracentrifuge, we will extract urinary exosomes and perform proteomics analysis and RNA-sequencing. The association between urinary exosomes and the degree of graft fibrosis will be analyzed to identify biomarkers that represent fibrosis. The correlation between these biomarkers and graft long term outcomes will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* end-stage renal disease patients receiving kidney transplantation from deceased donors who have the ability to provide content for this study

Exclusion Criteria:

* multi-organ transplantation candidate or history of previous transplant, history of extra-renal solid organ or bone marrow or stem cell transplant, active infection, history of recent intoxication of alcohol or substance abuse within 24 weeks
68Ga-HTK03149 for Use as a Diagnostic Radiopharmaceutical

This is a preliminary evaluation of a radiotracer's biodistribution in human subjects. It is a prospective, single-centre, open-label, single group assignment interventional study.

Prostate cancer is very common, and PSMA imaging is currently the most accurate means of localizing these tumours.

The goal is to evaluate the biodistribution and safety of \[68Ga\]HTK03149 PET/CT for prostate cancer imaging.

Each subject will have a PET/CT scan using \[68Ga\]HTK03149 . The \[68Ga\]HTK03149 radioactive tracer is manufactured for this study under a Clinical Trial Application filed with Health Canada.

After providing informed written consent subjects will complete a medical history questionnaire.

Monitoring of adverse events There will be short-term evaluation of adverse events by comparison of vital signs before and after administration of \[68Ga\]HTK03149 . Eighteen to seventy-two hours after \[68Ga\]HTK03149 administration the participant will return to the imaging department to perform a follow up safety assessment and routine blood draw. The study coordinator will ask the participant if they have experienced any adverse events during that time period and complete the adverse event questionnaire.

Follow-up Assessments

The following information will be collected up to 12 months following the PET/CT scans:

Initiation of a new treatment, Laboratory results and pathology reports, Results of imaging studies, Final clinical diagnosis by physician and relevant clinical notes. The study is expected to take up to 1 year for accrual.

Eligibility Criteria:
Inclusion Criteria:

* Participants with newly diagnosed or documented prostate cancers (PCa), with at least one measurable lesion based on CT, MR or at least one visualised lesion on PET/CT imaging (either from an 18F-DCFPyL or 68Ga-PSMA-11 PET).
* ECOG performance status of 2 or less.

Exclusion Criteria:

* Medically unstable (eg. acute illness, unstable vital signs)
* Unable to lie supine for the duration of imaging
* Unable to provide written consent
* Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
* Patients with widespread liver metastases occupying more than 50% of the liver volume will not be eligible to participate in this study as this would preclude assessment of normal liver activity for dosimetry purposes.
* Patients with baseline ALT or AST higher than 5× ULN or 250 U/L.
* Patients with elevated baseline levels of total bilirubin (higher than 1.2× ULN, or 1.3 mg/dL, (with exception of Gilbert's syndrome), with INR \>1.2, or platelet count below the lower limit of normal (typically \<150 000/μL.
* Patients with elevated alkaline phosphatase (ALP), equal to or higher than 2× ULN or 250 U/L, unless the ALP elevation is not from a hepatic origin.
A Study to Evaluate the Effects of Lithium and Valproic Acid on the Pharmacokinetics of KarXT and Effects of KarXT on the Pharmacokinetics of Lithium and Valproic Acid in Healthy Participants

The purpose of this study is to evaluate the effects of lithium and valproic acid on the single-dose pharmacokinetics (PK) of KarXT and the effect of KarXT on the single-dose PK of lithium and valproic acid in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female \[individual not of childbearing potential (INOCBP)\] participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory determinations.
* BMI of 18.0 to 32.0 kg/m2, inclusive.

Exclusion Criteria:

* History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results. Note: Any grade of hepatic impairment (Child-Pugh Grade A or higher) is excluded.
* Parts B and D only: History of pancreatitis.
* Any significant acute or chronic medical illness, in the opinion of the investigator.
* History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma or known history of prostate hypertrophy or nocturia.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Retrospective TMS Therapy for Adults With MDD

Examine change in the magnitude of antidepressant effects as a function of number of TMS sessions and to determine whether extended treatment courses, beyond 30 and beyond 36 TMS sessions, result in improved efficacy.

The efficacy of TMS in major depressive disorder (MDD) has markedly improved since the pivotal sham-controlled trials. While this enhanced efficacy has been attributed to use of longer treatment courses, the impact of number of treatment sessions on efficacy has not been adequately evaluated. The study device is the Neuronetics, Inc. NeuroStar® TMS Therapy System (K160703, K201158).The study is a retrospective analysis of real-world data from commercial centers. The data will be gathered from the Neuronetics database called TrakStar which collects records of each patient's treatment. The data will be used only as applicable to the objectives of this study.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female.
2. At least 18 years of age.
3. Treatment with NeuroStar TMS Therapy.
4. Treatment date of November 01, 2008 or later.
5. Patient received at least one treatment with NeuroStar TMS Therapy according to standardized NeuroStar TMS Therapy treatment protocols.
6. Primary diagnosis of Major Depressive Disorder (MDD) with no comorbid diagnosis.
7. PHQ-9 scores available at baseline (pre-treatment).
8. Moderate or greater depression prior to the initial treatment course with NeuroStar TMS Therapy, defined as baseline score on the Physician Health Questionnaire-9 (PHQ- 9) ≥ 10.
Effect Of Exercises On Kinesiophobia, And Other Symptoms Related to Osteoporosis

Aim: Investigating the effects of Clinical Pilates Exercise on kinesiophobia, pain, functional status and quality of life of the patients diagnosed with osteoporosis.

Method: 47 patients were assessed and randomly divided into 2 groups. Exercise group patients joined exercise program regularly that was held 3 times a week, 1 hour a day, during 6 weeks with physiotherapist. Control group patients continued their normal daily lives without any exercise. After 7 patients quit the study for various reasons, 40 women with primary osteoporosis (control group n=20, exercise group n= 20), completed the study and were assessed at the beginning and at the end of 6 weeks. As assesment' measurements Tampa Kinesiophobia Scale (TKS), Visual Analog Scale (VAS), Short Form McGill (SF-McGill), Pain Disability Index (PDI), Oswestry Disability Index (ODI), Berg Balance Test (BBT), Timed Up- Go Test (TUG), Chair Sit-Stand Test (CSST), Chair Sit and Reach Test (CSRT), Back Scratch Test (BST), Quality of life Questionnaire European Foundation for Osteoporosis (QUALEFFO-41), Hospital Anxiety and Depression Scale (HADS), Satisfaction with Life Scale (SLS) and Health Assesment Questionnaire (HAQ) were performed.


Eligibility Criteria:
Inclusion Criteria:

* Woman diagnosed with osteoporosis between the ages 50-75 within the last year

Exclusion Criteria

* History of fractures
* Joint replacements or fixation of the joints at the lower extremities or the spine
* Any neurological or muscle diseases
* Inability to continuously attend the exercise program
* Any secondary diseases resulting in decreased mobility or functional status
* Visual, hearing or mental problems that could prevent communication
A Comparison of Measurements of Ketone Body Flux Versus Ketone Body Concentration as a Pharmacodynamic Marker of Hepatic Fatty Acid Oxidation (0000-110)

This study will compare two approaches to the measurement of fatty acid oxidation (ketone body flux and ketone body concentration) and determine which method demonstrates superior sensitivity and variability in the detection of moderate increases in ketogenesis rates.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a Body Mass Index of 18-25 kg/m2 OR 29-40 kg/m2
* Subject has been a nonsmoker or has not used nicotine for the past 6 months

Exclusion Criteria:

* Subject has a history of diabetes mellitus
* Subject has a history of stroke, chronic seizures, or other neurological disorder
* Subject has a history of cancer, except certain skin cancers
* Subject consumes more than 3 alcoholic beverages per day
* Subject consumes more than 6 servings of caffeinated beverages per day
* Subject has multiple and/or severe allergies to food or drugs
* Subject has allergy or sensitivity to eggs or soy
* Subject regularly uses illicit drugs or has a history of drug or alcohol abuse
Comparative Study of Ceftaroline vs. Vancomycin Plus Aztreonam in Adult Subjects With Complicated Skin Infections

The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Additional purpose of this study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Eligibility Criteria:
Inclusion Criteria:

* Skin and skin structure infection (SSSI) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease.

Exclusion Criteria:

* Prior treatment of current complicated skin and skin structure infection (cSSSI) with an antimicrobial.
* Failure of vancomycin or aztreonam as therapy for the current cSSSI, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.
Neoneur Feeding System Functionality in the Clinic

Prospective data collection using the Neoneur Feeding System to demonstrate device functionality, correlation to historic data, and prepare for a more extensive phase II SBIR trial

The consented infant's assigned Speech Language Pathologist will use the Neoneur Feeding System 2-3 times a week from initiation of oral feeding until discharge, if oral feeding is prescribed. It can be used either as a special consult, or during routine care. The feeding is performed by the Speech Language Pathologist assigned to the infant. There will be no change in the infant's feeding plan. For infants consented to participate in the study, their feeding will include the Neoneur feeding system inserted between the nipple and bottle. When the Neoneur is inserted, it will capture both the suck and swallow changes (oral cavity pressure), and respiration (temperature changes) patterns.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants: requiring tube assisted feeding while in the NICU, gestational age at birth =\<34 week, extubated by term
* Infants with CHD: requiring surgery during the first month of life, gestational age \> 37 weeks

Exclusion Criteria:

* Premature infants: craniofacial anomalies, infants with grade IV intraventricular hemorrhage, apgar \< 5 at 5 minutes, short gut syndrome, history of NEC
* Infants with CHD: no other congenital anomalies, no history of major neurologic insult , listed for heart transplant, history of ECMO, intubated for \> 4 weeks, requiring additional surgery
Progressive Exercise After Operation of Rotator Cuff Rupture and Anterior Labrum Rupture

The purpose of this study is to evaluate the effectiveness of progressive strength training after rotator cuff and labrum operation of the shoulder joint.


Eligibility Criteria:
Inclusion Criteria:

* rupture of rotator cuff
* rupture of anterior labrum
* age 18 to 65 years
* motivated to continue in work life
* motivated for rehabilitation

Exclusion Criteria:

* former operation in the same joint
* major arthrosis in the same joint
* cervical disk herniation
* concised spinal cord
* conditions after cervical spine operations
* rheumatic diseases
* fibromyalgia
* pregnancy
* severe depression
* alcoholism
* misusing of drugs
* disease that prevents progressive exercise eg. back pain, heart disease