cyrilzakka/clinical-trials huggingface dataset:
Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain

The purpose of the proposed study is to evaluate the efficacy of the InterX 5000 in relieving chronic neck and shoulder pain. This study will focus on the efficacy of treating patients who have functional limitations in activity because of chronic/recurrent neck or shoulder pain.

H1: InterX therapy will have a moderate effect to reduce pain.

H2: Functional gains will be greater in patients receiving InterX therapy compared to those who received placebo treatment.

H3: Chronic neck and shoulder pain is more prevalent in patients who exhibit radiographic evidence of degenerative spondylosis/arthrosis of the cervical spine.

Electrical stimulation modalities of various types have been used as a therapeutic intervention for years in a wide variety of applications. Individuals with neck and shoulder pain represent a significant segment of the pain population seeking relief. However, there is a paucity of data from quality studies published in mainstream peer-reviewed journals supporting the effectiveness of this intervention. No well-designed prospective, randomized, controlled trials investigating the efficacy or effectiveness of this intervention in patients with chronic neck and shoulder pain have been reported. The need for such work is becoming increasingly important considering the progressively greater demands for evidence-based medicine to justify reimbursement for care.

Eligibility Criteria:
Inclusion Criteria:

* chronic or recurrent neck or shoulder pain of at least 3 months duration with or without arm pain
* willing to sign consent for study participation
* able/willing to comply with treatment schedule

Exclusion Criteria:

* clinically significant herniated disc (defined as positive radicular arm pain aggravated by head position change or neural stretch signs from provocative arm movement, this will not exclude patients with any imaged herniation as this is a common finding in all populations)
* spinal fracture
* previous electrical stimulation treatment for this episode
* recent cervical spinal or shoulder surgery or implanted instrumentation/prostheses.
* patients with cardiac pacemaker or spinal cord stimulator, epilepsy, pregnancy, recent (3 months) chemotherapy/radiotherapy, phlebitis, cortisone use (30 days)
Cardiac Biomarkers After Marathon Running and Coronary Atherosclerosis

This study evaluates cardiac biomarkers and their association to coronary artery disease in marathon runners.

The MaraCat study is an observational prospective study evaluating the association between cardiac biomarkers and coronary artery disease in 43 runners participating in the 2018 Paavo Nurmi Marathon. The study participants were recruited according to two age criteria - under 35 years and over 44 years of age. Comprehensive laboratory samples were collected immediately after the run, while the control workup was done in a separate visit with no significant physical excercise in the preceding two weeks. In the under 35 years -group, the control workup included an echocardiography, ecg and blood samples. In the over 44 years group, the control studies included coronary CT, echocardiography, ecg and laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Age under 35 years or over 44 years
* Participant of Paavo Nurmi Marathon 2018
* Informed consent signed

Exclusion Criteria:

* No informed consent
* existing coronary artery disease
BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect

This single center, double-blind, randomized study with up to 11 treatment groups evaluates the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of single ascending doses of BAY2328065


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, aged 18 - 45 years
* Body mass index (BMI): 18 ≤ BMI ≤ 30 kg/m²
* Smoking less than 10 cigarettes / day
* Signed informed consent
* Use of an accepted method of contraception for the duration of the study.

Exclusion Criteria:

* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders, thyroid disorders or malignant tumors
* Known severe allergies, non allergic drug reactions, or multiple drug allergies
* Medication history: any regular medication, esp. drugs known to induce/inhibit liver enzymes or transporters
* Clinically relevant findings in physical examination; ECG, blood pressure; laboratory values
Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen

This study is an uncontrolled, central registration system, open-label, multicenter observational study in patients using Kesimpta for the labeled indication.

This is a primary data collection-based special drug-use surveillance to be conducted in accordance with the GPSP ordinance.

Observational period will last 24 months from the start of treatment with Kesimpta.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must provide written consent to cooperate in this study before the start of treatment with Kesimpta
2. Patients using Kesimpta for the first time for the following indication Indication: prevention of relapses and and prevention of physical disability progression in the following patients

   * Relapsing-remitting MS
   * Active SPMS

Exclusion Criteria:

1. Patients with a history of treatment with a drug containing the same ingredient as Kesimpta (investigational drug or post-marketing clinical study drug)
2. Patients with a history of hypersensitivity to any of the Kesimpta ingredients
Machine Learning to Predict Factors Affecting Rehabilitation Length of Stay and Healthcare Costs for Neurological Rehabilitation

The aim of this retrospective study is to ascertain total direct costs, rehabilitation length of stay (RLOS) and factors associated with RLOS for neurological inpatient rehabilitation at the tertiary care hospital.

The aim of the study is to identify factors that influence RLOS and the correlated costs for neurological rehabilitation in tertiary rehab using data extracted from EPIC. It is also aimed to identify the median direct costs to find out the main contributors to the costs in the local population. Lastly, the study aims to utilise artificial intelligence or machine learning to analyse the compiled data to develop a predictive model. The model aspires to understand factors associated with extended RLOS and to predict RLOS of patients who require neurological rehabilitation, aiding preemptive measures.

Eligibility Criteria:
Inclusion Criteria:

• All patients who completed inpatient rehabilitation with the index conditions in their discharge summaries

Exclusion Criteria:

• Did not complete inpatient rehabilitation as they are discharged against medical advice
Treatment of Renal Angiomyolipomas in Tuberous Sclerosis by Beta-blockers

Treatment of angiomyolipomas is based on invasive techniques such as surgery or embolization. Development of anti-angiogenic therapies is a major and growing field of research in hypervascularized tumors. Angiomyolipomas have been shown to regress after prolonged treatment with mTOR inhibitors (Sirolimus), but with a large proportion of secondary effects. We showed recently that beta-blockers were able to induce regression of infantile hemagiomas. Consequently, we looked for and found, histologically, in a few cases of angiomyolipomas the presence of beta2 receptors.

The aim of the study is to estimate if beta-blockers could induce regression or stabilization of renal angiomyolipomas in tuberous sclerosis in a pilot study.


Eligibility Criteria:
Inclusion Criteria:

* Tuberous sclerosis patients with one or several angiomyolipomas of a size of at least 4 cms.

Exclusion Criteria:

* Patients whom CT or MR scan shows one or several intra-lesional aneurisms requiring a preventive embolization.
* Patients with a retroperitoneal hemorragic complication requiring a preventive embolization.
* Patients whom biopsy will show an adenocarcinoma, hypertension non controlled, renal failure and severe liver.
* Diabetic subjects insufficiently controlled.
* Beta-blockers contra-indication.
* Psychosis, severe mental disorder.
* Patient already treated with beta-blockers or mTOR inhibitors.
* Pregnant or nursing women.
Contribution of a Video Support to Inform the Patient Before a Complementary Examination in Infectious Diseases

The purpose of this study is that a video tool coupled with standardized information can increase the patient's understanding of the information and thus optimize their medical care

Patients admitted to the Infectious and Tropical Diseases Department (MIT) undergo a large number of complementary examinations. In view of their specificity, justified by the often lengthy diagnostic process, as well as by the complexity and diversity of the pathologies, the site of infection and the patient's background (adolescents and adults, migrant patients, immunocompromised patients, Human Immunodeficiency Virus, primary immunodeficiencies, organ transplants, patients with haemopathies, marrow transplants, among others). As a matter of practice, the doctor informs the patient of the prescribed examinations, explaining their purpose and procedure, and outlining any benefits and risks.

The intention is to introduce a tool that complements the information usually provided, and that can be of high quality to improve the patient's perception of understanding. To this end, investigators hypothesize that a tool in video format, built in collaboration with the experience of various technical platforms, could make the experience of understanding information more complete and more accessible to all patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years
* French speaking language
* Hospitalized in the Department of Infectious and Tropical Diseases at Hôpital Necker- Enfants malades
* Prescription, for the first time in its medical history, of one of the following complementary examinations:

  * Bronchial FibroscopyIRM
  * PICC line insertion
  * PET Scanner
* No expressed oral opposition

Exclusion Criteria:

* Patients with dementia or cognitive impairment
* Non-French-speaking patient

Caregivers' inclusion Criteria:

* Caregiver belonging at nurse or doctor's category
* Caregiver working in the Infectious and Tropical Diseases Department at Necker Hospital
* No expressed oral opposition
* Caregivers who are not in contact with patients
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)

The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating strong correlation between the AHI of diagnostic PSG and AL.

All subjects with suspected Sleep Disordered Breathing (SDB) scheduled for diagnostic polysomnography (PSG) will be invited to participate in the study to be tested to determine if they have Sleep Disordered Breathing (SDB), using the ApneaLink (AL) Sleep Screener. Subjects initially will be tested for SDB in the home environment. Following an AL home test, subjects will undergo a simultaneous, attended diagnostic polysomnography (PSG) sleep study and ApneaLink test for the purpose of confirming and comparing the results between diagnostic PSG and the AL device.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ( greater than 18 years of age) of either gender or any race
* Suspected sleep disordered breathing
* Untreated sleep disordered breathing
* Willingness to use AL at home within 2 days of receipt and instruction on the AL
* Willingness to use AL at home and undergo PSG within 2 to 4 weeks of completing the at home AL test

Exclusion Criteria:

* Any subject requiring home oxygen therapy
* Any subject currently receiving positive airway pressure therapy
New Imaging Biomarkers for Muscular Diseases - Multispectral Optoacoustic Imaging in Spinal Muscular Atrophy

This study aims to refine the capability of MSOT to characterise muscle tissue and to determine non-invasive, quantitative biomarkers for the disease assessment in patients with spinal muscular atrophy (SMA) using Multispectral Optoacoustic Tomography (MSOT).

SMA is an autosomal-recessive disorder, characterized by progressive muscle weakness and atrophy with an incidence of 1/10,000. The condition is caused by a homozygous deletion or mutation in the survival motor neuron 1 (SMN1), resulting in reduced expression of the survival motor neuron (SMN) protein. This leads to the degeneration of motor neurons in the spinal cord and brain stem. A nearby related gene, survival motor neuron 2 (SMN2), could partially compensate the loss of SMN1. Individuals with a higher copy number of SMN2 do in general have a milder phenotype. New therapeutic approaches, e.g. nusinersen (spinraza©), an antisense oligonucleotide medication that modulates pre-messenger RNA splicing of the survival motor neuron 2 (SMN2) gene, are promising to help the formerly incurable children. However, most clinical trials lack primary outcomes other than clinical testing. At the moment there are no prospective, quantitative biomarkers available to detect muscle atrophy at an early age, and to follow up disease progression. As a new imaging modality, optoacoustic imaging (OAI) combines benefits of optical (high contrast) and acoustic (high resolution) imaging. Multispectral optoacoustic tomography (MSOT) is therefore capable of visualizing the distribution of endogenous absorbers by initiating laser-induced thermoelastic expansion and detection of resulting pressure waves. This imaging technique enables the label-free detection and quantification of different endogenous chromophores, such as melanin, hemoglobin, deoxyhemoglobin and lipids. Previously, it was demonstrated that MSOT is capable to monitor disease severity in Crohn's disease by detecting different signal levels of hemoglobin as markers of intestinal inflammatory activity. In this study we want to refine the capability of MSOT to characterize muscle tissue and to determine a non-invasive, quantitative biomarker for the disease assessment in SMA patients from birth using MSOT.

Eligibility Criteria:
Inclusion Criteria:

* genetically proven SMA

Exclusion Criteria:

* Pregnancy
* Tattoo on skin to be examined
* For healthy volunteers only: suspected muscular disease/myopathia
COVID-19 Vaccines in Patients With Chronic Liver Disease

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused pandemic since outbreak in 2020.Patients with chronic liver disease (CLD) are at higher risk of mortality and morbidity due to COVID-19. Despite there is a large number of clinical trials of COVID-19 vaccines, only a few participants with chronic liver diseases were included.

This study is a prospective, open-label clinical trial. A total of 300 patients with different cancers including chronic hepatitis, cirrhosis .All of the patients will further accept 18 months follow-up study after vaccination. Safety and immunogenicity will be carefully recorded and detected.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Serum ALT and AST are both ≤ 80 U/L.
* HIV and TPHA screening were negative.
* Body temperature ≤37.0℃.

Exclusion Criteria:

* Patients who confirmed the diagnosis of liver cancer by imaging examination (CT/MRI/B scan).
* Patients who are allergic to any component of the vaccine, or have a serious history of vaccine allergy.
* Women who is pregnant, breastfeeding, or planning to be pregnant within 6 months.
* Patients with cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension can not be well controlled by drugs.
* Patients with severe chronic diseases or diseases can not be controlled well during the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired angioedema / neuroedema.c.
* Patients with urticaria within a year.
* Patients with coagulation disorder.
* Faintng during acupuncture treatment .
* Patients who received other investigational drugs within one month.
* Be receiving anti-TB treatment.
* Other conditions determined by the researcher.
Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER

This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studies

* EN10.A/RAINBO BLUE: POLE-mutated EC
* EN10.B/TAPER: p53 wildtype / NSMP EC

This study is being done in order to find out if this new approach is better or worse than the usual approach for early-stage endometrial cancer. The usual approach is defined as the care most people get for early-stage endometrial cancer.

The usual approach for patients who are not in a study is treatment with surgery. Tissue that is removed as part of this procedure is analyzed in the pathology laboratory to guide the doctor to decide whether or not additional treatment such as radiation and or chemotherapy should be recommended.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have had surgery consisting of hysterectomy and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards. There must be no macroscopic residual disease after surgery.
* Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
* Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
* Patients' age must be ≥ 18 years.
* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
* Patient is able (i.e. sufficiently fluent) and willing to complete the patient-reported outcomes (PRO) questionnaires in either English, French or a validated language
* Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre
* Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy

Exclusion Criteria:

* Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
* Prior pelvic radiation.
* Patients with a history of other malignancies, except: carcinoma in-situ without evidence of invasive disease when resected, adequately treated non-melanoma skin cancer, or other tumours curatively treated with no evidence of disease for ≥ 5 years.
* Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)
* Patients with a documented positive surgical margin.
* Patients with a documented positive peritoneal washings, if performed.
Curative Effect Evaluation of Danlou Tablet on Coronary Artery Disease Not Amenable to Revascularization

The purpose of this study is to determine whether Danlou Tablet is effective in the treatment of coronary artery disease not amenable to revascularization on the basis of western medicine therapy.

The western medicine treatment for CAD not amenable to revascularization is limited. Danlou Tablet, a kind of Chinese patent medicine has been used for treating coronary artery disease in clinical practice in China for many years.

Danlou Tablet is applicable to "phlegm-stasis syndrome" in Traditional Chinese Medicine. According to recent studies, Danlou Tablet can reduce blood lipid level and myocardial necrosis area ,promote infarct healing in rats.And it can improve clinical symptoms of patients with CAD.

Eligibility Criteria:
Inclusion Criteria:

* Participants are aged between 45 and 75 years, diagnosed with sever CAD through coronary arteriography which shows that the left main coronary artery and three-vessel have sever diffuse stenosis, calcification or vascular ectasia, be in accordance with Traditional Chinese Medicine syndrome of "Qi deficiency and blood stasis syndrome" or "phlegm and stasis mu-tual obstruction syndrome".

Exclusion Criteria:

* Patients with severe valvular disease, congenital cardiomyopathy decompensation
* Patients with CAD complicated with severe multiple organ disease such as severe heart failure, severe lung, liver or renal dysfunction, peptic ulcer in active stage, or intracranial hemorrhage
* Patients that use high-dose steroids due to connective tissue disease
* Patients with serious infections
* Patients with malignant tumor
* Patients with hematopoietic diseases
* Pregnant or lactating women.
A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)(P06473)(COMPLETED)

The primary purpose of this study is to investigate the contraceptive efficacy, safety and acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in various countries in order to obtain country-specific data.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects are healthy premenopausal women requiring a long-term method of contraception, with a body mass index between 18 and 29 kg/m2, who are willing to give voluntary written informed consent. Subjects must have regular cycles with a usual length between 24 and 35 days.

Exclusion Criteria:

* Male
* Postmenopause
* Infertile
* Under 18; Over 40
Intraoperative Contrast-Enhanced Ultrasound Evaluation of Blood Flow at the Time of Surgical Hip Reduction for DDH

This study evaluates the feasibility and utility of contrast-enhanced ultrasound to provide real-time assessment of blood flow to the femoral head in infants undergoing surgical reduction for developmental dysplasia of the hip.

For children presenting with late-diagnosed developmental dysplasia of the hip, a closed or open hip reduction followed by hip spica casting may be indicated if conservative treatment fails. Although closed or open reduction and casting is largely successful for relocating a hip, iatrogenic avascular necrosis remains a major source of morbidity as a result of the surgical procedure.

Although recent evidence has demonstrated that postoperative gadolinium-enhanced magnetic resonance (MR) studies may be useful in assessing perfusion of the hip after surgery, these studies are not performed until after the cast is placed and they do not elucidate the specific intraoperative steps that increase risk for osteonecrosis. Contrast-enhanced ultrasound (CEUS) may be a reliable and effective alternative.

Eligibility Criteria:
Inclusion Criteria:

* Males or females between 4 months and up to and including 24 months of age at the time of surgery.
* Diagnosed with DDH.
* Failed conservative treatment, or present with late-diagnosed DDH (where conservative treatment would not be appropriate to initiate at their age), and are undergoing closed or open reduction and spica casting.
* Informed consent (parental permission)

Exclusion Criteria:

* \> 24 months of age at the time of surgery.
* Subjects with DDH who are successfully treated with conservative measures and do not require surgical reduction.
* Previous open hip reduction of the affected side
* Children with known complex congenital heart disease or unstable cardiopulmonary conditions (as noted in the package labeling for Lumason) including acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure or serious ventricular arrhythmias will be excluded.
* History of allergic reaction to Lumason, sulfur hexafluoride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Ns), palmitic acid).Parental/guardian permission (informed consent) and if appropriate, child assent.