cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of a Modern Educational Intervention in Breast Cancer Patients

In addition to fatigue, pain is the most frequent and persistent symptom following breast cancer and breast cancer treatment. Despite the effectiveness of different physical therapy modalities, such as manual techniques, passive mobilizations and exercises, many patients still experience pain and subsequent difficulties in daily functioning at short and long term. Past decades, the awareness on the important role of educational interventions in the management of pain in general has increased. Educational interventions aim at explaining and improving the knowledge, control and attitude of the patient regarding his/her pain complaint. However, these educational interventions are often restricted to more biomedical pain management instructions and general advice on physical activity and analgesics (= traditional biomedical education). Only recently, increased knowledge on pain mechanisms led to a more modern educational approach. This modern approach is suited to explain more complex issues associated with pain and takes into account many more factors related to pain. To our knowledge, only one controlled trial investigated the effectiveness of a modern educational intervention in the early stage of breast cancer treatment. The results were very promising for shoulder function. However, only short-term effects were examined, no randomization was performed and no pain-related and socio-economic outcomes were evaluated. Therefore, the aim of the proposed project is to investigate the effectiveness of a similar modern educational program, in addition to standard physical therapy care, in the early treatment phase of breast cancer in comparison with traditional biomedical education. A randomized controlled trial will be performed with a long-term follow up period. The primary outcome parameter is pain-related disability. Secondary outcomes are different dimensions of pain, physical and mental functioning, return to work and health-care related costs.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary breast cancer
* Unilateral surgery including, either:

Axillary lymph node dissection and mastectomy/breast -conserving/reconstructive surgery OR Sentinel Node Biopsy and mastectomy/reconstructive surgery

Exclusion Criteria:

* Active metastasis
* Cannot participate during the entire study period
Luna Interbody System for Fusion Trial

The purpose of this trial is to evaluate the performance, safety and effectiveness of the Luna system for the treatment of degenerative disc disease.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 65 at the time of consent
2. Patient has back pain consistent with symptomatic degenerative disc disease at one level or two contiguous levels from L2-S1 requiring surgical intervention.
3. Patient has had at least 6 months of non-operative care
4. Patient is mentally capable and willing to sign a study-specific informed consent form
5. Patient is willing and able to comply with all study requirements
6. Patient has a score on the back pain visual analog scale (VAS) of ≥ 40 mm
7. Patient has an Oswestry Disability Index (ODI) score of ≥ 30%

Exclusion Criteria:

1. DDD affecting \>2 levels
2. Back pain due to causes other than DDD
3. Spine surgery within last 3 months or planned spine surgery within 6 weeks of post study procedure
4. \>Grade 1 spondylolisthesis or retrolisthesis
5. Infection at or close to target disc level
6. Active systemic infection
7. Patient has known osteoporosis
8. Prior interbody fusion at the target level
9. Prior failed interbody fusion at any level
10. Known allergy to device materials
11. Uncontrolled psychiatric illness or severe dementia
12. Pregnant at time of enrollment or considering getting pregnant during study period
13. Any metabolic or other bone disease that could significantly compromise pedicle screw and/or interbody device placement.
14. Any severe illness that would prevent complete study participation
15. Uncontrolled diabetes
16. Current use of chronic steroids (more than equivalent of 10 mg prednisone daily)
17. Contraindication to spinal surgery or general anesthesia
18. Coagulopathy
19. Body mass index \>35
20. Current smoker
21. Known illicit substance abuser
22. Currently participating in another investigational study that could affect responses to the study device
A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting

This national, open-label study is designed to give complementary efficacy, safety and patient reported outcomes (PROs) data in participants with active relapsing forms of MS. Participants will receive a maximum of 2 treatment cycles of ocrelizumab infusions: an initial dose of two 300 milligram (mg) infusions separated by 14 days followed by one single infusion of 600 mg ocrelizumab 24 weeks after the first infusion. Disease activity is determined by clinical relapses and/or Magnetic Resonance Imaging (MRI) activity.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/=18 years at screening
* Patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features: (i) at least one clinical relapse over a 6-month period prior to screening; (ii) AND/OR at least one T1 gadolinium-enhancing lesion or new and/or enlarging T2 lesion as detected by brain Magnetic Resonance Imaging (MRI) performed over a 3 months period prior to screening with no change of Disease-Modifying Treatment(s) (DMT) compared to a previous MRI performed within 24 months before screening
* For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 12 months after the last dose of ocrelizumab
* Participants should be beneficiary of healthcare coverage under the social security system

Exclusion Criteria:

* Diagnosis of primary progressive MS
* Inability to complete an MRI (contraindications for MRI include but are not restricted to weight ≥140 kg, pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc...)
* Gadolinium intolerance
* History of ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack) or ischemia of the spinal cord
* History or known presence of central nervous system (CNS) or spinal cord tumor (e.g., meningioma, glioma)
* History or known presence of potential metabolic causes of myelopathy (e.g., untreated vitamin B12 deficiency)
* History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-lymphotropic virus 1 (HTLV-1), herpes zoster myelopathy)
* History of genetically inherited progressive CNS degenerative disorder (e.g., hereditary paraparesis; MELAS \[mitochondrial myopathy, encephalopathy, lactic acidosis, stroke\] syndrome)
* Neuromyelitis optica
* History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjogren's syndrome, Behçet's disease, sarcoidosis)
* History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression)
* Vulnerable patients (Patient referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the French Public Health Code)
BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics

The goal of the project is to develop and validate the BioForte technology. Its main functionality should be to in silico determine candidates for novel microbiome-based therapeutics and diagnostics. Key challenge to be solved using the technology is to detect the differences in gut microbiome between oncology patients who respond to immunotherapies and the ones who do not respond to this treatment.

This technology employs machine learning methods to replace the laboratory procedure for finding valuable genomic features. Such features can be crucial to identify differences between the two populations (e.g. responders vs non-responders) to target specific strains.

The samples and data collected in this clinical study will be used for clinical validation of BioForte technology. For all patients treated with immunotherapy, stool collection will be performed per patient (one stool collection before setting up immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies). Samples will be sequenced by long-read sequencing technology. In parallel, we will also collect samples of peripheral blood samples (PBMC) and biopsy (FFPE).


Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥18 years of age.
* Patients with one of the following types of cancer: non-small cell lung cancer, melanoma.
* Patients with informed consent to participate in the study.
* Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
* The applied immunotherapy should be the first or second line of treatment.

Exclusion Criteria:

* Patients who are unable to understand, read and / or sign informed consent.
* Patients who can not collect stools.
* Patients with fecal transplant.
* The applied immunotherapy is not the first or second line of treatment.
RMOS Study : Impact of Manual Rotation of Occiput Posterior Position on Operative Delivery Rate (RMOS)

Introduction:

The frequency of fetuses in occiput posterior position during labor is approximately 20 %, in which 5% remain occiput posterior at the end of labor. Occiput posterior position is associated with higher risks of caesarean deliveries and operative vaginal deliveries. The manual rotation to promote rotation from a posterior to an anterior position has been proposed to reduce the extraction rate. There is no randomised trial comparing the effect of manual rotation and expectant management. We propose a protocol for a prospective, monocentric, randomised controlled clinical trial in order to show that the rate of spontaneous vaginal delivery is higher with manual rotation of occiput posterior position than with an expectative management.

Methods:

Every 37 weeks with a singleton pregnancy with a clinical occiput posterior position suspicion confirmed by a transabdominal ultrasound at full dilatation will be eligible. Participants will be randomised to either prophylactic manual rotation (experimental group) or expectative management (control group). Based on an alpha value of 0.05 and gaining 20% for spontaneous vaginal delivery, 238 participants will need to be enrolled.

The primary outcome will be spontaneous vaginal delivery. Secondary outcomes will be operative delivery rate (caesarean section , vacuum or forceps deliveries), significant maternal and perinatal mortality/morbidity.

Analysis will be by intention-to-treat averaging a 24-month period.


Eligibility Criteria:
1. Inclusion Criteria:

   * age ≥ 18 years
   * singleton pregnancy

     -≥37 weeks of gestation
   * planned vaginal birth
   * cephalic presentation
   * occiput posterior position confirmed by ultrasound at full dilatation
2. Exclusion Criteria:

   * withdrawal of consent
Modifying the Workplace to Decrease Sedentary Behavior and Improve Health

The primary objective of this project is to determine the effects of decreasing sedentary behavior at work by at least 3hrs/day using treadmill (walking and standing) and sit-to-stand (standing only) workstations on the health of overweight office workers.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index greater than 25 kg.m-2
* Does not engage in any structured physical activity lasting at least 30 mins for more than 2 days/week
* Employed in a full-time sedentary desk job.
* No major orthopedic limitations or medical conditions that prevents walking or standing at a treadmill work sit-stand workstation.

Exclusion Criteria:

-
To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries

The aim of this study is to provide baseline acute otitis media data in East European countries.

Each subject's involvement in this study will include a retrospective and prospective part.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
* A male or female subject aged \< 6 years at the time of enrolment.
* The investigator has access to the medical records that contain the medical history of the subjects for one year prior to enrolment (for subjects aged 1 to \< 6 years) or from birth (for subjects aged \< 1 year).
* Written informed consent obtained from either both parents/ LARs or from one parent/ LAR of the subject with the declaration of cooperation for one year after enrolment.

Exclusion Criteria:

* Acute otitis media episode at the time of enrolment.
* Upper respiratory tract infection at the time of enrolment.
Digital Training Interventions for Low Back Pain

The patients will be clinically examined, as well as evaluated with Patient Reported Outcome Measures (PROMs) and Magnet Resonance Imaging (MRI) at baseline and at follow-ups.

The overall aim is to evaluate two different types of digital training interventions supervised by physiotherapists compared to daily physical activity in terms of clinical, imaging-based and patient-reported outcome in patients with low back pain. Furthermore, to evaluate whether new diagnostic MRI methods can identify longitudinal spine tissue changes and to analyse if there is an exercise-related difference.

Patients seeking primary health care for lower back pain will be randomized to three groups. The patients will be clinically examined, assessed with Magnet Resonance Imaging (MRI) and Patient Reported Outcome Measures (PROMs) will be evaluated at baseline and at follow-ups.

A detailed description of the study protocol, see attached document.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain\> 3 months
* Age 18-50 years
* Access to computer/tablet/mobile phone

Exclusion Criteria:

* Inadequate Swedish as the language is an obstacle to be able to fully understand written and oral information regarding the project and to follow training instructions
* Other ongoing treatment/exercise for their low back pain
* Patients with radiating leg pain and neurological symptoms where herniated discs are suspected
* Previous back/neck surgery
* Pregnancy
* Diagnosed systematic diseases engaging the spine as rheumatoid arthritis, ankylosing spondylitis
* Factors that prevent an MRI examination, such as claustrophobia, metal implants, etc.
Single Arm Study of Induction Chemoradiotherapy Combined With Surgery in the Treatment of Locally Advanced SNMM

Sinonasal mucosal melanoma (SNMM) is a very rare tumor, and SNMM is highly aggressive in nature, with a 5-year survival rate of about 20\~30%. Most patients underwent local recurrence and distant metastasis within one or two years of treatment.

There is no unified standard for the treatment of SNMM.The principle of treatment for surgically resectable stage T3 and partial T4 SNMM is complete resection of the primary tumor, combined with postoperative radiotherapy. While locally unresectable SNMM has a poorer prognosis, lower incidence, fewer clinical data have been reported.

This study will explore the role of preoperative radiotherapy and chemotherapy in improving the 2-year OS rate, loco-regional control rate and distant metastasis rate.


Eligibility Criteria:
Inclusion Criteria:

1. Age over 18 years old;
2. Pathologically confirmed with sinonasal mucosal melanoma;
3. Eligible for assessment by enhanced contrast computed tomography scan or magnetic Resonance Imaging (MRI);
4. T4N0-1M0 according to the 8th edition American Joint Committee on Cancer (AJCC) staging system, and breaks through the natural anatomical boundaries of orbital fascia or dura mater; or 2) any Tumor stage, with retropharyngeal node metastasis. unresectable tumor after multi-disciplinary team (MDT) discussion.
5. Eastern Cooperative Oncology Group (ECOG) score between 0 to 2;
6. No distant metastasis;
7. Adequate organ function;
8. Sign the informed consent forms.

Exclusion Criteria:

1. There is evidence or suspicious of distant metastasis on clinical examination or imaging examination;
2. suffered from uncontrolled concurrent diseases that may interfere with treatment;
3. Suffered from another malignant tumor or multiple primary tumors at the same time within 5 years (excluding fully treated basal cell or squamous cell skin cancer, cervical cancer in situ, etc.);
4. With surgical contraindications: severe cardiopulmonary disease, coagulation dysfunction, etc;
5. With and conditions that interfere with patient compliance or safety;
6. With severe mental or neurological diseases;
7. Uncontrolled active infection diseases;
8. Pregnant or breastfeeding women;
9. Patients without personal freedom or independent civil capacity;
10. Other situations that are not suitable.
Discrimination Harassment of Pain Staff Caused by Patient

Chronic pain is associated with mental disorders, and some patients have behavioral issues. Some patients may sexually or racially harass pain clinic staff. Healthcare staff do not usually report sexual or racial harassment perpetrated by patients.

Quantitative and qualitative analysis of prospective electronic and clinic diary data. Evaluation of incidents of sexual and racial harassment of clinic staff; perpetrated by patients. Analysis of causative factors, incident outcome, system factors and lessons learned.

Chronic pain disorder may be associated with mental health disease. Many patients exhibit behavioral problems. Some of the patients may sexually or racially harass the pain clinic staff. Typically, healthcare providers do not report racial or sexual harassment perpetrated by patients.

This is a quantitative analysis of prospective electronic and clinic diary data. It evaluates many incidents of sexual and racial harassment of pain clinic staff; perpetrated by patients. It analyzes the incident causative factors, incident outcomes, system factors and lessons learned. The qualitative information of each incident is presented in a sensitive and careful format.

Eligibility Criteria:
Inclusion Criteria:

* adult chronic pain patients

Exclusion Criteria:

* pediatric chronic pain patients
A Multicentre Study in Otherwise Healthy Infants and Toddlers Hospitalised For and Diagnosed With RSV Lower Respiratory Tract Infection to Evaluate the Safety, Tolerability, and Clinical Activity of ALX-0171

The primary objective of the study is to investigate the safety and tolerability of ALX-0171.

The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is otherwise healthy, but hospitalised for and clinically diagnosed with RSV LRTI (Lower Respiratory Tract Infection)
2. Subject has appearance of upper or lower respiratory tract infection symptoms that are likely related to RSV
3. Subject has a positive RSV diagnostic test
4. Others as defined in the protocol

Exclusion Criteria:

1. Subject has history of wheezing
2. Subject is known to have significant comorbidities
3. Subject is known to be immunocompromised
4. Subject is suspected of having a clinically relevant infection other than RSV
5. Others as defined in the protocol
CONFIRM - Comparison of in Office Interrogation Versus Remote Measurements

The primary objective of this study is to evaluate the efficacy of the automated data collection in the Zephyr device as compared to manual testing results for atrial and ventricular pacing thresholds. The secondary objectives include: to compare the in-clinic time needed to retrieve and document the automated device measurements for all tests to the additional time needed to manually measure sensing, impedance and thresholds for the same patient; to compare the accuracy of the automated device test results to manual testing results; evaluate the percentage of patients who are recommended for ACapTM Confirm utilization.

The Primary Hypotheses are:

1. The values reported from ACapTM Confirm will be within 0.125 V of the value that is obtained manually in clinic.
2. The values reported from VentricularAutoCaptureTM will be within 0.125 V of the value that is obtained manually in clinic.


Eligibility Criteria:
Inclusion Criteria:

* Patients have been implanted with their device \~ 6 months prior
* Patients must have their device evaluated at the enrolling center.
* Patients must be able to comply with the regular routine follow-up schedule of the enrolling clinic.
* Patients must be able and willing to provide written informed consent to participate in the clinical trial.
* Patients age 18 or greater.

Exclusion Criteria:

* Patient has a unipolar atrial lead implanted.
* Patients who are or may potentially be pregnant.
* Patients with persistent AF.
* Less than 1 year life expectancy
Safety of Thoracoscopy in Patients With High Risk

Medical thoracoscopy can be performed for diagnostic as well as therapeutic purposes. Thoracoscopy in the diagnosis of pleural diseases is highly sensitive for detecting pleural neoplasia with negative pleural fluid cytology and in the diagnosis of tuberculosis. The indication of thoracoscopy in patients with pleural effusion has been optimized. In some studies medical thoracoscopy has been claimed a useful diagnostic tool with a very low rate of complications. However the investigators do not know its safety on high risk patients. Because many patients having suspected malignancy have bed conditions due to other health problems such as coronary heart diseases, COPD, arrythmia, hypoxemia. In this study the investigators aimed to test the safety of medical thoracoscopy in the patients with high risk for complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients with exudative pleural effusion

Exclusion Criteria:

* Patients without pleural effusion
I-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)

The purpose of the clinical investigation is to generate clinical data to substantiate the safety and performance of the i-Stitch device for bilateral sacrospinous ligament fixation (SSLF) in pelvic organ prolapse (POP) repair.

The i-Stitch instrument is a reusable instrument for attaching sutures to tissue with or without surgical mesh implants in urogynaecology. It is used together with the i-Stitch loading units. The use of i-Stitch for the fixation of surgical urogynaecological mesh implants (e.g. BSC Mesh, InGYNious) has already been proven in several studies.

The aim of the present retrospective study is to generate clinical data to show the safety and performance of the i-Stitch instrument in bilateral sacrospinous ligament fixation (SSLF) without the use of a surgical mesh.

Eligibility Criteria:
Inclusion Criteria:

* Surgery for POP
* SSLF with usage of i-Stitch device (\& i-Stitch Loading Units)
* Concomitant procedures are allowed
* Women minimum 18 years old
* Written informed consent for surgery

Exclusion Criteria:

* infection (active or latent)
* allergies to the materials used
* benign or malignant changes
* anticoagulation disorders
* autoimmune connective tissue disorders
* any uterus pathologies