cyrilzakka/clinical-trials huggingface dataset:
Spine Rehabilitation Using Spine Flexion / Extension Full Active Range of Motion for Patients With Chronic Low Back Pain

The main objective of this study is to assess efficacy of a spine rehabilitation program, using spine flexion and extension full active range of motion, on physical disability of patients with chronic low back pain.

Secondary objectives

The other objectives of this study are to assess the impact of spine rehabiliation program using spine flexion and extension full active range of motion on :

* pain intensity ;
* kinesiophobia
* active range of motion of lumbar flexion and lumbar extension

Conduct of research

After receiving the written consent of the study, participants will benefit from 5 sessions of spine flexion and extension full active range of motion exercises. The following tests and questionnaires will be performed before (baseline) and after (posttreatment) the 5 sessions :

* Visual Analogue Pain Scale,
* Fear Avoidance Beliefs Questionnaire (FABQ),
* Double-inclinometer to measure active range of motion of lumbar flexion and lumbar extension.

Eligibility Criteria:
Inclusion Criteria:

* Medical prescription for chronic low back pain rehabilitation
* Evolution of low back pain for at least 3 months
* No treatment or rehabilitation for low back pain performed within 12 months before enrollment
* Written informed consent given

Exclusion Criteria:

* Spinal fracture or previous spinal surgery
* Cognitive impairments that prevent from understanding the rehabilitation exercises
* Patient with insufficient understanding or expression in French
* Non-mechanical pain : gradually worsening pain, present at rest and especially at night
* Neurological symptom : deficit in the control of bladder and anal sphincters, motor weakness of lower limbs, Cauda equina syndrome
* Pubis paresthesia (or perineum)
* Severe trauma (such as fall from height, traffic accident)
* Unexplained weight loss
* History of cancer
* Drug use or long-term use of corticosteroid
* Spinal deformity
* Altered general condition
* Patient with signs of neurological impairment : positive Lasegue test (Straight Leg Raise Test) or positive Slump test, or DN4 questionnaire greater than or equal to 4
* Patient suffering from a central or peripheral neurological pathology
* Patient taking a level II (weak opiates) or III (morphine and related substances) analgesic treatment
* Patient under guardianship, curatorship or legal protection
Evaluation of Middle Ear Implantation

The middle ear implant are used for patients with mild to severe sensorineural hearing loss, who cannot benefit from conventional hearing aids because of medical reasons such as chronic external otitis or external skin irritation. The device is also available for patients who are dissatisfied with the conventional hearing aids because of poor sound quality, feedback or occlusion of the ear canal. To date, more than 1500 patients have been implanted in Europe and about more than 600 patients in France. The aim of the present study is to compare in a randomized study the performances of the system to those of the conventional hearing aid in patients with similar degree of hearing loss.

Objective: The main objective of this study is to demonstrate that the middle ear implant increases the hearing in terms of speech intelligibility in quiet and noisy conditions, in patients who have no further benefit of their conventional hearing aid. The quality of life of these patients will be evaluated as well as the tolerance of the middle ear implant after 6 months.

Design of the study: 420 patients with mid or severe hearing loss will be included. They will have for 3 months the best conventional hearing aid adapted to their hearing loss. The first 84 patients who will not have a benefit of this hearing aid, will be randomised in two groups. The patients of the first group will be operated as soon as possible, the surgery of the patients of the second group will be delayed by 6 months. The whole duration of the study is 48 months.

Evaluation criteria: Audiological testing (pure-tone hearing thresholds, speech comprehension in quiet and noise), and subjective evaluation using self-assessment scales will be performed before and 6 months after the implantation in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* adults patients
* hearing loss
* accept to participate
* having health insurance

Exclusion Criteria:

* known disease that needs MRI follow up
* contraindication to middle ear surgery
The Value of Diaphragmatic Ultrasound in Non-invasive Oxygen Therapy

In this study, a single-center, prospective, observational study was adopted to set the cut-off values of diaphragmatic ultrasound results and arterial blood gas results，with the choice of non-invasive oxygen therapy as the gold standard,so as to evaluate the diagnostic value of diaphragmatic ultrasound in the selection of non-invasive oxygen therapy.

1. the cut-off values of diaphragmatic ultrasound results and arterial blood gas results were established by the selection results of non-invasive oxygen therapy of 120 patients in the intensive care unit and using receiver operating Characteristic curve.

diaphragm excursion，inspiratory time，diaphragm contraction velocity，diaphragm excursion time

Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years
* without Invasive mechanical ventilation when entering the intensive care unit.

Exclusion Criteria:

* have noninvasive ventilation or high flow nasal cannula contraindications
* history of neuromuscular disease chest wall deformities
* previously assessed diaphragmatic palsy
* shock or severe hemodynamic instability
* known pregnancy, and/or need for immediate endotracheal intubation
Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis

The aim of our study is to assess the effect of a combined physiotherapy and osteopathy treatment versus a placebo on the management of disability and quality of life after lumbar arthrodesis. This study will provide a better assessment of the use of osteopathy as a non pharmacological approach to post-operative management.

For this purpose, We will analyze the effects of these two approaches, targeted and non-targeted osteopathy (TO vs. NTO), on patients' disability and quality of life after surgery.


Eligibility Criteria:
Inclusion Criteria:

* having experienced a lumbar arthrodesis (of one to three levels) four weeks before inclusion
* being under a stable pharmacological treatment over the last month
* who are suffering from postoperative mechanical pain (VAS ≥ 4)

Exclusion Criteria:

* neuropathic pain according to a DN4 score greater than or equal to 4/10,
* are suffering from fibromyalgia,
* algodystrophy,
* other somatic or neuropsychiatric diseases (other than depression and anxiety),
* have received osteopathic treatment over the last three month prior to inclusion,
* are included in another interventional research protocol during the study period
Anterior Segment Optical Coherence Tomography Microstent Positioning

The goal of this observational study is to learn about the long-term results of glaucoma stent surgery in men and women 18 or older who have had cataract and microstent surgery in the past 2 years at the Moran Eye Center. The main questions the study aims to answer are:

1. How often are microstents mispositioned?
2. What effect does microstent positioning have on intraocular pressure after surgery?

Participants will have a one-time clinic visit for an eye exam and Optical Coherence Tomography (OCT) .

From the eye exam and OCT, Researchers will assess and categorize the position of the microstents and assess the Schlemm's canal dilation.

Researchers will review the participants' medical records to acquire 2-year data for the following:

1. Surgeon type and level of experience (resident, fellow, attending ophthalmologist)
2. Proportions of proper gonioscopic placement intraoperatively for each surgeon group
3. Effectiveness of surgery, based on change in intraocular pressure (IOP) from baseline medicated IOP, number of IOP-lowering medications the patient was able to discontinue, and rate of need for additional glaucoma surgery.


Eligibility Criteria:
Inclusion Criteria:

* Any adult glaucoma patient (age 18+) who underwent Hydrus microstent or iStent Inject placement at the Moran Eye Center.

Exclusion Criteria:

* Any patient who subsequently had to have their stent removed for any reason, any patient with a history of trauma to the anterior segment or reconstruction altering typical anatomy.
Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19

The IMPACT-SIRIO 5 is a randomized, double-blind, phase III clinical trial aimed to evaluate safety and efficacy of PCSK9 inhibition on clinical outcome in patients during the inflammatory stage of the COVID-19. During the hospitalization participants will be randomized in a 1:1 ratio to either receive PCSK9 inhibitor (evolocumab) or to receive placebo (saline solution). Furthermore, all people included in the study will be treated in accordance to the latest recommendations on the treatment of patients infected with SARS-CoV-2.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent for participation in the study
2. Male and female age 18 or more at the time of signing the informed consent
3. SARS-CoV-2 infection confirmed by Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR)
4. COVID-19 pneumonia with a typical radiological changes
5. PaO2/FIO2 ratio less than or equal to 300
6. COVID-19 Pneumonia in cytokine storm with elevated serum level of interleukin-6

Exclusion Criteria:

1. Use of fibrates other than fenofibrate or fenofibric acid
2. Known active infections or other clinical condition that contraindicate PCSK9 inhibitors
3. Known systemic hypersensitivity to PCSK9 inhibitors
4. Estimated glomerular filtration rate \<30 ml/min/1.73 m2
5. Absolute neutrophil count (ANC) less than 2000/mm3
6. A platelet count less than 50000/mm3
7. Creatine kinase (CK) greater than 3x upper limit of normal (ULN)
8. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3x upper limit of normal (ULN)
9. Not expected to survive for more than 48 hours from screening
10. Unrelated co-morbidity with life expectancy \<3 months.
11. Pregnancy
12. Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study
13. Patient being treated with other immunomodulators (except for glucocorticoids).
14. Patient included in any other interventional trial.
Polyp REcognition Assisted by a Device Interactive Characterization Tool - The PREDICT Study

Diminutive colorectal polyps (≤ 5 mm) represent most of the polyps detected during colonoscopy, especially in the rectum-sigmoid tract. The characterization of these polyps by virtual chromoendoscopy is recognized as a key element for innovative imaging techniques. As a matter of facts diminutive colorectal polyps are very frequent and, if located in the rectosigmoid colon, they present a very low malignant risk (0.3% of evolution towards advanced adenoma and up to 0.08% of evolution towards invasive carcinoma). The real-time characterization would allow to identify the lowest risk polyps (hyperplastic subtype), to leave them in situ or, if resected, not to send them for histological examination, allowing a huge saving in healthcare associated costs.

Recently, the American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee established the Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document, specific for real-time histological assessment for tiny colorectal polyps, to establish reference quality thresholds. Two performance standards have been developed to guide the use of advanced imaging:

1. for diminutive polyps to be resected and discarded without pathologic assessment, endoscopic technology (when used with high confidence) used to determine histology of polyps ≤ 5mm in size, when combined with the histopathology assessment of polyps \> 5 mm in size, should provide a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps;
2. in order for a technology to be used to guide the decision to leave suspected rectosigmoid hyperplastic polyps ≤ 5 mm in size in place (without resection), the technology should provide ≥ 90% negative predictive value (when used with high confidence) for adenomatous histology.

Computer-Aided-Diagnosis (CAD) is an artificial intelligence-based tool that would allow rapid and objective characterization of these lesions. The GI Genius CADx was developed to help endoscopists in their clinical practices for polyps characterization.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40-80 undergoing screening colonoscopy for CRC
* Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation.

Exclusion Criteria:

* subjects positive to Fecal Immunochemical Test or Fecal Occult Blood Test;
* subjects undergoing CRC surveillance colonoscopy
* subject at high risk for CRC
* subjects with a personal history of CRC, IBD or hereditary polyposic or non-polyposic syndromes;
* patients with previous resection of the sigmoid rectum;
* patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings;
* patients who perform an emergency colonoscopy.
Effect-site Concentration of Remifentanil for Blunting Hemodynamic Responses to Double-lumen Endobronchial Intubation

The purpose of this study is the comparison of the effect-site concentration of remifentanil for blunting hemodynamic responses to ordinary tracheal and double-lumen endobronchial intubation during propofol-remifentanil total intravenous anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient who is needed intubation for general anesthesia

Exclusion Criteria:

* patient who is anticipating difficult airway
* patient who takes any drug to influence this study
* cardiovascular disease, renal disease, liver disease
The MONET - Study: MR Mammography of Nonpalpable Breast Tumors

The purpose of this study is to determine whether performing MRI of the breast will improve breast cancer management by reducing the number of biopsies and in case of malignancy allowing one-stage surgical excision of the tumor.

Each year 7000 women present with nonpalpable suspicious breast lesions on mammography in the Netherlands. In the usual care situation, these lesions are detected by mammography and ultrasonography and pathologically characterized by analysis of large core needle biopsy material. In case of malignancy, these lesions are surgically removed. First, a wire is placed in the breast with the tip of the wire within 1 cm of the tumor and then the surgeon follows the wire and removes the lesion. Unfortunately about 25% of women require more that one surgical procedure to remove all tumorous tissue. This is caused by incorrect presurgical diagnosis of the extent and invasiveness of the disease (multifocality, multicentricity, lymph node involvement). We hypothesize that MR mammography will improve presurgical diagnosis and differentiation of lesions and thereby decrease the number of invasive surgical procedures (primary outcome) and number of invasive biopsies (secondary outcome).

Eligibility Criteria:
Inclusion Criteria:

* patients with a nonpalpable, mammographically suspicious breast lesion (BI-RADS 3, 4 or 5)
* referred for large core needle biopsy
* 18 to 75 years

Exclusion Criteria:

* previous breast surgery or radiation therapy of the breast less than 9 months before MR mammography
* pregnant or lactating
* claustrophobia or adiposity ( \> 130 kg)
* general contraindications for MRI
* unable to maintain prone position for one hour
* medically unstable patients
Peri-implant Vitamin D and Cathelicidin (LL-37) Levels

This research aims to explore the influence of vitamin D on the body's defense system by examining its impact on specific proteins involved in immune response and inflammation in the soft tissues surrounding dental implants. Also aims to determine how vitamin D levels affect these proteins and their role in protecting peri-implant tissues from microbial infections and inflammation.

This cross-sectional clinical study examined 33 patients with 105 dental implants, classified as having either healthy peri-implant tissues or peri-implant diseases. Participants had not received peri-implant treatment in the past six months or taken medications affecting peri-implant tissues in the last three months. Eligible implants had been functional for at least 12 months with prosthetic superstructures that allowed sample collection. Patients with uncontrolled systemic conditions, metabolic bone diseases, autoimmune disorders, or those who were pregnant or breastfeeding were excluded.

Clinical assessments were conducted at six peri-implant sites, measuring probing depth (PD), clinical attachment level (CAL), modified plaque index (mPI), modified sulcus bleeding index (mSBI), and keratinized mucosa width (KMW). Bone loss was evaluated using radiographs. Patients were categorized into three groups based on the 2017 Classification of Periodontal and Peri-implant Diseases: peri-implant health, peri-implant mucositis, and peri-implantitis (35 implants per group).

Peri-implant sulcus fluid (PISF) samples were collected for 25(OH)D and LL-37 analysis using enzyme-linked immunosorbent assay (ELISA). Statistical analysis included normality tests (Kolmogorov-Smirnov), descriptive statistics, one-way ANOVA with Tukey HSD, Kruskal-Wallis with Dunn's test, chi-square tests, and Spearman's correlation for non-normally distributed data.

Eligibility Criteria:
Inclusion Criteria:

* Not received peri-implant treatment in the previous six months.
* Had not used vitamin D supplements, antibiotics, anti-inflammatory drugs, or any medications that could affect peri-implant tissues in the last three months.
* Patients with dental implants had been in function for at least 12 months, had been under functional loading for at least six months, and had prosthetic superstructures that allowed for unobstructed sample collection.

Exclusion Criteria:

* Uncontrolled systemic conditions, disorders affecting peri-implant tissues, metabolic bone diseases, autoimmune disorders.
* Pregnancy or breastfeeding.
Role of Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery

The purpose of this study is to determine whether brain oxygenation measured by cerebral oximeter has an impact on neurocognitive dysfunction.

Both postoperative delirium (PD) and postoperative cognitive dysfunction (POCD) are well known complications seen in elderly patients after cardiac surgery. The etiologies of PD and POCD are unknown, but cerebral ischemia remains a prime candidate. Attempts to correlate reduced levels of systemic oxygenation (i.e. SpO2) with the development of PD/POCD have been to date disappointing.

We believe that cerebral oximetry, a noninvasive technology that continuously monitors cerebral tissue oxygen saturation (SctO2), will enable us to answer the question of whether or not a correlation exists.

The availability of an absolute cerebral oximeter (FORE-SIGHT), with its ability to establish and manipulate threshold values for SctO2, provides us the opportunity to assess the relationship between cerebral oxygenation and the development of neurocognitive complications.

We propose a randomized, masked trial of 120 patients, adequately powered to assess the following:

* Is there an association between deficits in cerebral oxygenation and the occurrence of PD at some time in the 1st 5 days after the operation?
* Is there an association between deficits in cerebral oxygenation and changes in POCD scores shortly (5 days) after the operation and/or 4-6 weeks later? We hypothesize that individually tailored patient management guided with intraoperative and postoperative absolute cerebral oximetry monitoring using a tailored protocol designed to maintain SctO2 values above a specific threshold will result in improved neurocognitive outcomes in geriatric patients undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* 65 and older
* Elective cardiac or thoracic aortic surgery
* Capable and willing to consent
* Participants literate in English

Exclusion Criteria:

* Emergency Surgery
* Major Neurological Disease
* Gross Cognitive Dysfunction
* Patients not expected to be able to complete the 1 week and 3 months post-operative visit.
The Effects Of Oculomotor Exercises And Hands-On Protocol In Non-Specific Neck Pain

This study aimed to evaluate the effectiveness of adding oculomotor techniques and hands-on treatments to routine exercise protocols for individuals with non-specific chronic neck pain (NSCNP).

A randomized controlled trial was performed at the orthopedic rehabilitation clinic. Ethical Standards in the 1946 Declaration of Helsinki, as revised in 2013, were followed, and the University Ethics Board approved the study (approval number 147). This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors. The study was conducted with individuals aged 18-65 who applied to a private clinic, received a doctor's diagnosis, met the inclusion criteria, and voluntarily agreed to participate in the study.

Participants A total of 38 subjects were calculated as the minimum required sample size determined by power analysis, and 38 subjects aged 18 to 65 years with a diagnosis of nonspecific neck pain who met the inclusion criteria and voluntarily agreed to participate were included in the study. Signed consent forms were obtained from the volunteers who agreed to participate in the study by face-to-face interview.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria included being between ages 18 and 65 old, having been diagnosed with nonspecific neck pain, being able to comply with exercise instructions and understand evaluation questions, and volunteering to participate in the research.

Exclusion Criteria:

History of acute or chronic musculoskeletal pain other than nonspecific neck pain, history of a rheumatological disease, sequestered or extruded disc herniation, having received physical therapy in the last three months, recent history of surgery, infectious and vascular diseases, and cooperation and communication problems presence were excluded.
Robotic Rehabilitation and Dual-Task Exercises in Hemiplegic Patients

The aim of this study was to investigate the effectiveness of dual-task exercises combined with robotic rehabilitation applied to post-stroke hemiplegia patients.

This research is designed as a randomized controlled experimental study. The study will be conducted on 50 hemiplegic patients. Participants will be randomly divided into two groups. Patients in the exercise group will be subjected to dual-task exercises together with robotic rehabilitation. Patients in the control group will be subjected to only the robotic rehabilitation treatment program. Both groups will be treated with 30-45 minute sessions, 3 days a week for 12 weeks. The exercises will be explained to the patients in detail one-on-one and repeated.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of post-stroke hemiplegia (hemiplegia onset must be between 3 months and 1 year).
* Age range: 45-65 years.
* Voluntariness to participate in rehabilitation.
* Patients with a motor function loss of 30-70% according to Fugl-Meyer Motor Assessment results.
* Literacy

Exclusion Criteria:

* History of active psychiatric disease.
* Severe joint deformities or other neurological diseases.
* Having had a recent stroke during rehabilitation.