cyrilzakka/clinical-trials huggingface dataset:
Translation, Cultural Adaptation and Validation of Urdu Version of VISA-A Questionnaire

This study is designed to translate and validate the VISA-A questionnaire to the Urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of Pakistan. The translated version of the gold standard tool will be used by the local population as well as Urdu-speaking immigrants across the globe to better understand and report the severity of their symptoms. Hence, to improve quality of life across cultures, there is a need of standard outcome measures in Urdu language.


Eligibility Criteria:
Inclusion Criteria:

* Individuals aged over 18 years and both genders.
* Athletic population with the diagnosis of unilateral mid-portion or insertional Achilles tendinopathy, paratendinosis, partial tendon rupture with or without retrocalcaneal bursitis.
* With positive Painful arc sign and Royal London Hospital Test.
* Healthy individuals.

Exclusion Criteria:

* Complete rupture of Achilles tendon,
* Pregnant women and those with any history of radicular pain or lower extremity injury
* Previous surgery
Subcutaneous Peripheral Nerve Stimulation (PNS) as "Hybrid Stimulation" After Failure of Spinal Cord Stimulation (SCS) to Control the Back Pain Component in Failed Back Surgery Syndrome (FBSS) Patients.(CUMPNS Study)

Despite globally favourable outcomes of Spinal Cord Stimulation (SCS), a significant proportion of Failed Back Surgery Syndrome (FBSS) patients do not obtain adequate coverage of low back pain. Peripheral Nerve Stimulation (PNS) has obtained the European Conformity mark for the treatment of chronic refractory neuropathic pain and is now commonly used in some countries to target back pain. However, the potential value of combining SCS and PNS as "hybrid stimulation" remains poorly described with only isolated case reports or limited experience in various indications.

The "CUMPNS" comparative randomized study is designed to demonstrate the potential analgesic efficacy of PNS in addition to previously implanted SCS, to treat the residual low back pain component pain in refractory FBSS patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 80 years.
* History of FBSS after one or more surgical procedures on the spine, treated with SCS,
* Failure of well conducted conservative treatment (drug or non-drug).
* Patients implanted with a single-column or multicolumn SCS lead providing significant relief of the radicular pain component.
* Persistent failure on the low back pain component despite the efficacy of SCS on the radicular pain component.
* Patients with documented residual neuropathic low back pain (DN4, sensorimotor studies, clinical examination, pain characteristics, etc.).
* Patients with significant residual low back pain with mean intensity on Visual Analogue Scale (VAS) ≥ 40 mm) despite Conventional Medical Management (CMM) and SCS (mean measure calculated on daily VAS scores on 5 consecutive days).
* Positive response to Transcutaneous Electrical Nerve Stimulation (TENS) trial on the back pain component.
* Patients understanding and accepting the study constraints.
* Patients covered by French national health insurance.
* Patients have signed the Informed Consent Form after being provided with clear and honest information about the study.
* Absence of active psychosis or serious psychotic history requiring hospitalisation.
* Absence of active cancer.

Exclusion Criteria:

* Age \< 18 years and \> 80 years.
* Back pain amenable to further aetiological biomechanical surgery (discogenic pain, spinal instability, spinal deformity, etc.).
* Surgical, psychiatric or anaesthetic contraindication to PNS lead implantation.
* Negative response to TENS trial.
* Absence of signature of the informed consent form.
* Patients not covered by French national health insurance.
* Subjects requiring closer protection, i.e. minors, pregnant women, nursing mothers, subjects deprived of their freedom by a court or administrative decision, subjects admitted to a health or social welfare establishment, major subjects under legal protection, and finally patients member of a high-risk population.
* Women of childbearing age not using effective contraception.
Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy

The investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing Nerve Restoring (NR) Robotically assisted laparoscopic radical prostatectomy (RALP). During this study a total of 10 patients who are undergoing robotic prostatectomy will have their surgery performed utilizing a novel technique, NR-RALP, which incorporates a genitofemoral (GFN) nerve graft designed to try to improve the erectile function and recovery of men undergoing standard of care robotic prostatectomy while minimizing additional morbidity of the procedure

Patients will have baseline evaluation with International Index of Erectile Function-5 (IIEF-5) questionnaire and the Short Form McGill Pain Questionnaire (SF-MPQ)1, which will be re-evaluation at time of their standard of care post-operative visits at 4 weeks, 3-, 6-, 12- and 18-months. Post-operative safety will be assessed by recording any clinically detected complications during their peri- and post-operative care.

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by any of:

   1. Gleason grade ≥8
   2. PSA ≥20
   3. \>pT2 on preoperative MRI imaging
2. Patients must have preoperative erectile function with a baseline IIEF score of ≥17

Exclusion Criteria:

1. Patients with previous pelvic surgery
2. Patients with previous pelvic radiotherapy
3. Patient with previous focal therapy for prostate cancer
4. Patients aged \< 18 years at diagnosis
5. Legally incapable patients
6. Patients who are unable to complete questionnaires and have no companion to help complete them
7. Patients undergoing a concomitant cancer surgery
8. Patients with pre-existing neurologic disease
Fever and Neutropenia in Pediatric Oncology Patients

It is possible to distinguish between pediatric oncology patients who are at high or low risk for serious infection during periods of fever and treatment related neutropenia based on clinical parameters. Patients with low risk can be safely treated as outpatients primarily using oral antibiotics. It is possible to improve methods of risk stratification through the addition of genomic and proteomic factors.

Outpatient management of patients considered to be at low risk for serious bacterial infection has been explored using risk stratification schema based on clinical parameters. First, patients will be stratified based on a clinical risk stratification schema. Patients stratified to the low risk group will be randomized between treatment using standard inpatient intravenous antibiotic therapy or outpatient antibiotic therapy using primarily an oral regimen. Second, an evaluation of proteins important to the innate immune system will be performed to provide a molecular characterization of episodes based on etiology. Third, single nucleotide polymorphisms in genes important for innate immunity will be evaluated to determine effect of each on infection risk during treatment induced neutropenia. Finally, we will develop a bank of both plasma and DNA specimens correlated with clinical outcomes for future use.

Eligibility Criteria:
Inclusion Criteria:

1. Any pediatric patient age \<21 years with an oncology diagnosis who is undergoing therapy and is expected to have treatment related neutropenia.

Exclusion Criteria:

1. Any patient who has previously undergone autologous or allogeneic bone marrow transplant will be excluded from study enrollment. If a patient is expected to undergo autologous or allogeneic bone marrow transplant as part of therapy at some point after enrollment in the study he/she will be removed from the study at the start of their bone marrow transplant.
2. Any patient with a documented allergy to Levofloxacin or any other fluoroquinolone will be excluded.
3. Patients with a known pregnancy will be excluded.
4. Any patient with an underlying chronic musculoskeletal condition (ie Juvenile rheumatoid arthritis, Systemic lupus erythematosis etc) which may make evaluation for joint toxicity related to quinolone treatment difficult.
Tirelizumab Combined With Chemotherapy in the Treatment of HER-2 Negative Locally Advanced Gastric Cancer

This study objectively analyzes the safety and survival evaluation of perioperative immunotherapy combined with chemotherapy in locally advanced gastric cancer patients through a prospective randomized controlled trial research method; By comparing the pathological response rate, disease-free survival rate, and incidence of adverse events between the combination therapy and chemotherapy alone group, we aim to verify the efficacy and safety of tirelizumab combined with SOX/XELOX chemotherapy in disease control of locally advanced gastric cancer patients, laying the foundation and providing a basis for large-scale multicenter clinical research.


Eligibility Criteria:
Inclusion Criteria:

* The subjects voluntarily joined this study and signed an informed consent form
* Locally advanced gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology as HER-2 negative (cT2-4N+M0 Phase II-III)
* The primary lesion can be surgically removed, and the patient is willing to receive surgical treatment
* There are measurable solid tumors (efficacy evaluation standard: RECIST 1.1)
* Tumor evaluation should be conducted through CT scanning or MRI within 28 days before treatment
* ECOG score 0-1
* Life expectancy ≥ 12 months.

Exclusion Criteria:

* Preoperative imaging examination indicates distant or peritoneal metastasis in patients
* Subjects with any known active autoimmune disease
* Serious cardiovascular disease
* The serum of the subjects tested positive for HIV
* Active hepatitis B (HbsAg positive and HBV-DNA ≥ 10 \^ 3copies/mL) or active hepatitis C (HCV antibody positive and HCV-DNA positive, requiring antiviral treatment at the same time)
* Known subjects with previous allergies to macromolecular protein formulations/monoclonal antibody components, or other contraindications to immunotherapy or chemotherapy
* Have a history of alcohol, drug, or substance abuse
* Individuals with a clear history of neurological or mental disorders, such as epilepsy, dementia, and poor compliance
Photobiomodulation and Platelets Rich in Growth Factors (PRGFs)-Assisted Flap Surgery in Treating Stage III Periodontal Defects

Stage 3 periodontitis is a condition marked by swift and severe destruction of periodontal tissues. To effectively regenerate osseous defects resulting from periodontal disease, it is crucial to leverage the intrinsic regenerative potential of the periodontium via meticulously formulated therapeutic strategies

The main treatment methods of periodontal diseases involve scaling and root planning (SRP), and periodontal surgery. Periodontopathogens, can penetrate deep by crossing the epithelial barrier which may be difficult to be remove by nonsurgical periodontal therapy (NSPT) alone. A multitude of grafted and non-grafted approaches have been used in the management of Intra-bony defects. However, they do not provide predictable periodontal regeneration.

A systematic review on the use of platelet-rich fibrin (PRF) for managing periodontal defects highlights its promising potential in periodontal regeneration. It forms a fibrin matrix that promotes angiogenesis and enhances healing at defected sites. The review emphasizes PRF's ability to sustain the release of growth factors, which are crucial for osteoblastic proliferation, migration, and adherence. This makes PRF an effective scaffold for cellular elements, facilitating periodontal tissue regeneration.

Laser photobiomodulation (PBM) has emerged as a promising adjunctive treatment as it stimulates cellular processes, enhancing the natural regenerative capabilities of periodontal tissues. Recent studies have demonstrated that PBM, particularly with diode, significantly improves clinical outcomes when combined with conventional periodontal treatments. It promotes osteoblastic proliferation, migration, and adherence, thereby facilitating bone regeneration and reducing periodontal pocket depth. Additionally, PBM enhances angiogenesis and modulates the release of growth factors, creating an optimal healing environment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PPD =5 mm and clinical attachment loss of ≥3 mm;
* Presence of 2 walled or 3 walled infra-bony defects posterior segments;
* Evidence of ≥3 mm of intra-bony defect depth evaluated by the visualization of peri-apical radiographs.

Exclusion Criteria:

* Patients requiring antibiotic prophylaxis before the periodontal examination;
* Patients diagnosed with malocclusion at the site of the defect;
* Patients with systemic disease and/or on drugs that contraindicate periodontal surgery;
* Patients with a history of smoking and pan chewing;
* Sites with advanced class II \& III furcation involvement.
A Research Study, Looking at How Tresiba® Works in People With Type 2 Diabetes in Local Clinical Practice in Saudi Arabia

The purpose of the study is to collect information on how Tresiba® works in real world patients. Patients will get Tresiba® as prescribed to them by their study doctor. The study will last for about 6 to 8 months. Patients will be asked questions about their health and diabetes treatment as part of their normal study doctor's appointment.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* The decision to initiate treatment with commercially available Tresiba® has been made by the patient/legally acceptable representative and the treating physician before and independently from the decision to include the patient in this study
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes and treated with any antihyperglycaemic medication(s), except Tresiba®, for at least 26 weeks prior to Informed consent and Initiation Visit (Visit 1)
* Available and documented HbA1c value measured within the last 12 weeks prior to initiation of Tresiba® treatment

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Hypersensitivity to the active substance or to any of the excipients as specified in the Tresiba® local label
Use of Wii Fit (TM) to Increase Compliance With Home Exercises in Treating Patellofemoral Syndrome

To determine the utility of the Wii Fit TM interactive video game program in patellofemoral symptom resolution, development of increased muscle strength and flexibility as a result of increased compliance with home exercises in adolescent females with patellofemoral syndrome.

Patellofemoral syndrome (PFS) is a very common diagnosis amongst adolescents and young adults. Symptoms can be chronic in nature and interfere with sporting activity and activities of daily living. Current treatment consists of home exercises to increase muscular strength and flexibility. Adolescents are known to have poor compliance with treatments for chronic illnesses.

There is a paucity of published literature surrounding the Wii TM Interactive Video Game. There has been one published report of the use of Wii Fit TM in rehabilitation where participants used the Wii Fit TM to train proprioception after ankle injury. Individuals that participated in the Wii Fit TM group found improvement in their balance on objective measures as well as increased enjoyment with their treatment plan. One anecdotal report used the Wii TM video game in physiotherapy treatments of a college athlete and found a dramatic increase in attendance compliance after introduction of the video game.

This randomized controlled study will determine if using the Wii Fit TM for home exercise completion will increase compliance and subsequently improve symptoms related to patellofemoral syndrome in adolescent females.

Eligibility Criteria:
Inclusion Criteria:

* Female between ages of 11 and 17 years of age
* A diagnosis of patellofemoral syndrome with one or more of the following symptoms: anterior knee pain, positive theater sign, stairs provoking knee pain.
* No physiotherapy or regular, structured home exercise program is being followed
* Parental/guardian consent to participate
* Patient assent to participate

Exclusion Criteria:

* Patients participating in physiotherapy at the time of initial assessment or have had physiotherapy in the last 6 months for patellofemoral syndrome
* Patients performing regular home exercise program prescribed by physician, physiotherapist, or other allied health professional for patellofemoral syndrome at time of initial assessment
* Patients who have additional knee pathology (e.g. acute patellar dislocation; acute internal knee derangement (i.e. meniscal, ligament injury); osteochondritis dissecans; severe apophysitis or tendinitis) that could interfere with rehabilitation exercises due to pain or instability from these conditions
* Individuals with history of knee surgery
* Individuals that have a Wii Fit TM video game at home
* Individuals for whom consent and assent is not obtained
The Integration of Sensor Technology Into Incontinence Materials: a Single-group Pretest-posttest Study in a Nursing Home Environment

The smart diaper aims to (1) detect humidity, (2) be capable of sending real-time indication of the saturation to the healthcare workers when urine loss occurs and (3) generate alerts when the diaper requires changing. Potential benefits of the smart diaper compared to incontinence management products without sensor technology include: workload reduction, increased comfort for residents and staff, more person-centred care, increased quality of care, less skin damage and economic (e.g. less costs due to less excessive diaper changes), and/or environmental (e.g. less waste) gains.


Eligibility Criteria:
Inclusion Criteria:

* Resident of nursing home
* Urinary incontinence or double incontinence (Katz score incontinence ≥ 3) by day and night. (Score assessed in one week interval before start study period 1 and 2 "D1")
* Wearing adult diapers as incontinence material, size M.
* Unable to change diaper independently when saturated or leaking (Katz score toileting ≥ 3). (Score assessed in one week interval before start study period 1 and 2 "D1")
* Written informed consent from resident or resident's legal representative.
* Dutch speaking

Exclusion Criteria:

* Residents who are receiving end-of-life care
* Residents with a Mini-Mental State Examination (MMSE)-score of \< 24
* Residents with a dominant belly sleeping position
Efficacy Study of a Urine DEK ELISA for Diagnosis of Bladder Cancer

The objective of this study is to use a DEK ELISA to quantitatively measure DEK protein in the urine of patients suspected of having bladder cancer. The measurement of urine DEK protein, relative to an established cut-off, is correlated with the presence or absence of bladder cancer.

Sample Collection:

Urine samples used in the study will be collected immediately prior to the urological evaluation procedure and stored at -80 oC. Urine samples will be sent to sponsor and remain at -80o C until analysis.

Clinical Data Collection:

All subject and clinical information will be recorded on the form in section 9.3. Enrollment Checklist and Case Report Form (CRF). Information regarding the history of hematuria and urine cytology will be recorded. In addition, non-identifying information including age, sex, race, smoking history, alcohol consumption, occupational exposure to chemicals or dyes, history of urologic disorder or disease, history of irritative voiding symptoms, history of urinary tract infection, history of pelvic irradiation, and analgesic abuse will be recorded. The Investigators will also be asked to provide information from the subjects' medical records for up to one (1) year after their enrollment and sample collection. In particular, diagnosis of TCC, other malignant diseases, or non-malignant urogenital conditions will be provided.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least twenty-five (25) years of age with hematuria, dysuria or other irritative voiding symptoms, without evidence of other causative factors such as infections or stones.

Exclusion Criteria:

* Females who are pregnant (ascertained by history)
* Females who are menstruating or within three (3) days of their last menstruation
* Patients who have undergone invasive procedures of the urogenital tract in the past two (2) months
* Patients with a history of transitional cell carcinoma (TCC) of the urinary tract
Validation of the 3D-CAM Turkish Version

3D CAM into Turkish validity and reliability on postoperative delirium will be test as a prospective diagnostic study. After approval by Dr. Edward R. Marcantonio, (15) will translation and back-translation. The original 3D-CAM will translate into Turkish by two medical doctor .The two translational versions will be discussed and merged into a final version. Back translation will performed in regardless of any information from its original version by another two medical doctor. Both the translated and back translated versions will sent to Dr. Marcantonio for approval. Eligibility and the documentation of consent will be confirmed at the preoperative visit. During this visit, patients will provide demographic and historical medical information, including information regarding medication usage. The Mini-Mental State Exam (MMSE) will be performed.

Delirium assessment

Delirium assessment with the 3D-CAM Before the study period, all researchers will participate online training program on 3D CAM. Delirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days.

Delirium assessment with the DSM-5 The psychiatrist investigator who was blinded to the 3D-CAM assessment results, will evaluate the patients according to the criteria of DSM-5 within 3 min after the 3D-CAM assessment.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* ASA Physical Status 1-3
* Admitted to the ICU after surgery with a predicted length of stay for more than 48 h
* MMSE ≥ 20 (to exclude dementia)

Exclusion Criteria:

* Refused to participate
* Patients with severe visual or auditory disorder/handicaps or endotracheal intubation which might impede communication
* Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, Alzheimer or dementia, Parkinsonism
* Deep sedation or coma
* ASA physical status IV or V