cyrilzakka/clinical-trials huggingface dataset:
Impact of a Technique of Massage During the First Week of Hospitalization on the Recycling of the Mobility of the Knee Further to the Installation of Knee Replacement

During fthe first postoperative days, physiotherapists supported patients with knee replacement in orthopaedics of Saint-Junien's and Limoges' hospitals. This support includes movements of the leg in active and non active motions, without any help and with an arthromotor, and involves walking rehabilitation.

The investigators would like to complete the physiotherapist's support with manual lymphatic drainage (MLD) using a specific method based on pressure of finger splayed (PFS). This might have a positive impact on time recovery of joint range, on postoperative oedema resorbtion and on patient's pain during rehabilitation classes.

French National Authority for Health specifies there is not a single study assessing massage effects on knee replacement, according to current bibliography.

The investigators purpose is the establishment of a prospective, controlled, randomised trial referred as a "superiority" trial. A total of 98 patients divided in 2 parallel groups will be created.

The study will be in an open-label manner for both patient and physiotherapist involved in walk rehabilitation but will be conducted as a blinded study for the investigating physiotherapist.

Inclusion period will be 17 months and the following period will be 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* At least 18-years-old patients.
* Men and women operated for a knee replacement.
* Patients affiliated to a social security system and having given their informed consent write.

Exclusion Criteria:

* Patients operated on Fridays
* Patients presenting contraindications to the administration of a treatment by héparine
* Patients affected by insane pathology or by confusion.
* Patients participating in another medical research
* Pregnant and breast-feeding women and without effective contraception.
* Patients under guardianship or guardianship.
Infrazygomatic Versus Intranasal Injection Sphinopalatine Ganglion Blockade Effect on Surgical Field in FESS

This study aimed to show the effect of sphinopalatine ganglion blockade on surgical field, hemodynamics and postoperative pain in FEES operation.

Functional endoscopic sinus surgery (FESS) is a minimally invasive, effective surgical technique that is commonly used to treat chronic rhino sinusitis and nasal polyposis.

Intra-operative bleeding obscures the surgical view and increases the likelihood of iatrogenic complications. There are many factors that can affect the amount of bleeding experienced during surgery including both patient and surgical factors. These include severe forms of chronic sinusitis with nasal polyposis which is associated with increased vascularity, use of anticoagulant therapy, bleeding disorders, active infection, vascular tumor on the surgical site and revision surgery may affect bleeding on surgical site.

Sphenopalatine ganglion (SPG) is the main sensory innervation to the nasal mucosa.

The Sphenopalatine ganglion block (SPGB) is one of the regional anesthetic techniques that were used effectively before removal of nasal packing and in patients undergoing endoscopic sinus surgery under general anaesthesia to control bleeding or for postoperative analgesia

Eligibility Criteria:
Inclusion Criteria:

* Patients of ASA physical status I-II.

Exclusion Criteria:

* Patients of ASA physical status III or above.
* Patients with clinically significant cardiovascular, pulmonary or hepatic disease.
* Patients with bleeding diathesis or on anticoagulant therapy.
* Age less than 21 years.
* Mentally disabled patients.
Utility of Gene Test Analysis for Diagnosis, Prognosis and Treatment of Patients With Genetic Arrhythmic Heart Disease: the ARRHYTHMIC GENE-HEART

The goal of this observational study is to enroll all patients evaluated at the specialized Cardiogenetic Center within the Cardiology Department of the University of Ferrara, Italy. The primary aim of the registry is to collect comprehensive clinical, genetic, and electrophysiological data from individuals with suspected or confirmed arrhythmogenic conditions. By systematically documenting patient demographics, family history, clinical presentations, diagnostic findings, and treatment outcomes, the registry seeks to enhance our understanding of the genetic basis and clinical implications of genetically driven arrhythmias and systemic syndromes. This registry will facilitate long-term follow-up of enrolled patients to assess the natural history of arrhythmogenic disorders and the effectiveness of various therapeutic interventions. Additionally, it aims to identify potential risk factors associated with adverse outcomes, such as sudden cardiac death or major arrhythmic events.

Cardiogenetics is essential in daily clinical practice, providing critical insights into the genetic basis of inherited cardiovascular conditions. This knowledge enables more accurate diagnoses, risk assessments, and personalized management strategies for patients. By understanding the genetic underpinnings of arrhythmias and other heart diseases, healthcare providers can identify at-risk individuals and their family members, facilitating early intervention and preventive measures. Establishing an observational registry for these conditions is vital, as it systematically collects data on patient demographics, clinical presentations, genetic findings, and treatment outcomes. This comprehensive database enhances our understanding of the natural history and variability of genetic cardiovascular disorders while supporting research efforts aimed at developing improved diagnostic tools and therapeutic approaches. Ultimately, such a registry can enhance patient care by informing clinical guidelines and fostering collaboration among clinicians, geneticists, and researchers in the field.

Therefore, the goal of this observational study is to gather extensive clinical, genetic, and electrophysiological data from individuals with suspected or confirmed arrhythmogenic conditions. By systematically documenting patient demographics, family history, clinical presentations, diagnostic findings, and treatment outcomes, the registry aims to deepen our understanding of the genetic basis and clinical implications of genetically driven arrhythmias and systemic syndromes.

Eligibility Criteria:
Inclusion Criteria:

* Patients evaluated at the Cardiogenetic Center of the University of Ferrara in Ferrara, Italy.
* Having a proven cardiogenetic disease

Exclusion Criteria:

* Refuse to provide informed consents
* Patients not having a cardiogenic disease
To Investigate the Therapeutic Effect of Aculife Magnetic Therapist on Carpal Tunnel Syndrome

Carpal tunnel syndrome (CTS) is the most common compressive focal mononeuropathy seen in clinical practice. Patients commonly experience a constellation of symptom complex brought on by compression of the median nerve as it traverse through the carpal tunnel. When compression of the nerve occurs, ischemia and mechanical disruption of nerve function may result. Pathological analysis shows a constellation of nerve injuries. Until now, no satisfactory conservative treatment method. Local steroid injections or oral steroids may result in initial relief, but relapses are frequent and have much side effects, which preclude their routine use for CTS. Full time wrist splints are claimed effective, but compromise hand function and daily activities. There are reasonable studies showing relief of pain with acupuncture on diverse pain conditions. However the therapeutic efficacy of acupuncture in CTS was less convincing in the past. Until recent decade, some case reports and few prospective studies reported the therapeutic effect of acupuncture in CTS. Other study also reported that low-level laser and microamperes transcutaneous electrical nerve stimulation (TENS) are effective in improvement of clinical outcome of patients with CTS. Another report suggested that TENS should be considered for the treatment of painful diabetic peripheral neuropathy. Therefore, the investigators perform this study to evaluate the effect of Aculife Magnetic Wave Therapist (a battery operated device with a probe electrode which contains magnetic elements that transform the oscillating current into an electromagnetic wave to stimulate the acupuncture points, simulate the effect of electroacupuncture ) on CTS and compared with that of Transcutaneous Electrical Nerve Stimulation(TENS). After at least 4 weeks treatment ( at least 16 treatment sessions) the therapeutic effects will be evaluated by comparison of symptom severity score, electrophysiological study, sonographic morphology study or magnetic resonance imaging study, before and after treatment, and between the different groups.


Eligibility Criteria:
Inclusion Criteria:

* electrodiagnostic study confirmed with carpal tunnel syndrome
* clinical symptom related to carpal tunnel syndrome

Exclusion Criteria:

* hypothyroidism, gout, systemic lupus erythematosus, rheumatoid arthritis, diabetes mellitus, chronic renal failure, acromegaly, polyneuropathy, brachial plexopathy, proximal median nerve entrapment, deficiency neuropathy (vitamine 2, B12, ect.), drug usage that may cause neuropathy, any surgery for peripheral nerve in the upper limb such as carpal tunnel surgical release, history of trauma in the upper limb such as wrist fracture, or having pregnancy.
Behavioral Intervention for Insomnia in Older Adults

The purpose of the study was to evaluate and compare the efficacy of single interventions (stimulus control instructions, sleep restriction therapy) and multi-component intervention (stimulus control instructions and sleep restriction therapy) for chronic insomnia in community dwelling older adults. The subjects were randomly assigned to one of four conditions: stimulus control instructions, sleep restriction therapy, multi-component treatment (stimulus control instructions and sleep restriction therapy), or measurement control.


Eligibility Criteria:
Inclusion Criteria:

* 55 years or older
* Sleep onset or maintenance insomnia of 45 minutes or more per night for at least 3 nights per week as ascertained through 14 days of sleep diaries
* Insomnia duration of at least 6 months
* Impaired daytime functioning as a consequence of insomnia

Exclusion Criteria:

* Psychopathology evidenced by the Brief Symptom Inventory Global Severity Index T score \>60
* Cognitive impairment as ascertained by the Mini-Mental State Exam score \< 27
* Current psychotherapy or medical treatment for major depression or other psychopathology
* Current and regular use of over-the-counter medication or prescription medication for sleep (verified through urinalysis), or any medication affecting sleep
* Major physical or mental illness directly related to the onset and course of insomnia
* Substance abuse problem ascertained per interview
* Suspicion of sleep apnea as determined by an Epworth Sleepiness Scale score of 11 or greater, a respiratory disturbance index of \> 15 as established through in-home overnight use of the EdenTec Model 3711 Digital Recorder, and interview with a significant other, if available
* Restless leg syndrome, periodic limb movement disorder, or circadian rhythm sleep disorders as determined through the participant interview and an interview with a significant other, if available.
Fasting Study of Alendronate Sodium Tablets (70 mg) and Fosamax Tablets (70 mg)

The objective of this study is to investigate the bioequivalence of Mylan's alendronate sodium 70 mg tablets to Merck's Fosamax 70 mg tablets following a single, oral 70 mg (1 x 70 mg) dose administration under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
Short-term Blinatumomab as a Bridge Therapy for Allo-HSCT in Low Burden B-ALL

The goal of this single-arm, prospective study is to test in low-burden B-cell lymphoblastic leukemia (B-ALL) patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is:

• The efficacy and safety of short-term blinatumomab as a bridging therapy to allo-HSCT in patients with low-burden B-ALL. Participants will take intravenous blinatumomab prior to allo-HSCT with an initial dosage of 8 μg/day. The dosage gradually escalated to 28 μg/day and continued for 5 to 10 days. Dexamethasone 20mg was administered 1 hour before the onset of blinatumomab infusion.


Eligibility Criteria:
Inclusion Criteria:

1. patients diagnosed with B-ALL;
2. patients with age ≥ 16 years;
3. Availability of both pre- and post-transplantation disease status records.

Exclusion Criteria:

1. administration of blinatumomab therapy for more than 14 days;
2. patients with leukemia burden ≥ 10% before initiation of treatment;
3. patients with severe organ dysfunctions before treatment, including myocardial infarction, chronic heart failure, decompensated liver dysfunction, renal dysfunction, or gastrointestinal dysfunction;
4. patients with central nervous system leukemia.
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Prolonged Open Label Extension Phase

The purpose of the study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of amnestic or non-amnestic Mild Cognitive Impairment.
* Mini-Mental State Examination score higher than 24 at screening.
* MRI scan of the brain at screening with fluid-attenuation inversion recovery (FLAIR) and T2\*-weighted gradient-recalled-echo (GRE) sequences.

Exclusion Criteria:

* Diagnosis of Alzheimer's disease according to the (DSM-IV-TR) or NINCDS-ADRDA criteria.
* Any medical condition that could explain the patients cognitive deficits.
* CT or MRI brain imaging results obtained within 12 months prior to baseline showing evidence of infection, infarction, or focal lesions of clinical significance
* MRI scan at screening showing more than 4 cerebral microhemorrhages (lesions with diameter ≤ 10 mm).
* Geriatric Depression Scale (30-point scale) score \> 9 at screening.
* History of stroke.
* Modified Hachinski ischemic scale score \> 4 at screening.
* Women of childbearing potential.
* Vitamin B12 or folate deficiency.
* Diagnosis of schizophrenia or recurrent mood disorder (including unipolar and bipolar disorders) within 3 years of screening.
* Current diagnosis of peptic ulcer or gastrointestinal bleeding within the last year and/or chronic inflammatory bowel disease.
* Concomitant use of donepezil at doses \> 5 mg/day or other cholinesterase inhibitors (rivastigmine or galantamine) at any dose.
* Concomitant use of memantine at dose \> 20 mg/day.
* Concomitant use of psychoactive drugs (sedatives, hypnotics, etc).
Safe and Fast Radial Hemostasis Using Synergistic Strategies: SAFE & FAST Trial

The Safe and Fast Radial Hemostasis using Synergistic Strategies (SAFE \&amp; FAST) trial is an interventional study aimed at reducing the incidence of radial artery occlusion (RAO) rebound bleeding, and the required compression time after transradial approach (TRA) procedures, which have become the default access for coronary procedures globally. The hypothesis is that combining lower-dose heparin and radial hemostasis with simultaneous ipsilateral ulnar artery compression could achieve these improved outcomes.

Patients referred for diagnostic trans-radial cardiac catheterization who meet the inclusion criteria will be randomized into two groups. Group 1 will receive a standard heparin dose (50 U/Kg) with a total compression time of 2 hours using the TR band ® . Group 2 will receive a reduced heparin dose (25 U/Kg) and a compression time of 60 minutes using the VASOBand™, with simultaneous ipsilateral ulnar artery compression.

The study's primary endpoint is a composite of rebound bleeding, post-procedural RAO, and hematoma formation. Radial artery patency will be evaluated using ultrasonography.

With an expected complication rate of 8.2% in Group 1 and 4.5% in Group 2, a sample size of 207 patients per group will provide an 80% power to demonstrate non-inferiority for the treatment group at the alpha 2.5% level. The statistical analysis plan will use descriptive statistics for baseline data and 95% confidence intervals for outcome variables. If non-inferiority is demonstrated, there will be a superiority test performed to examine if Group 2 is superior.

In conclusion, the SAFE \& FAST trial intends to establish a safer, quicker protocol for hemostasis after TRA procedures, with the potential to reduce patient recovery time and improve procedure throughput in cardiac catheterization laboratories.

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred for diagnostic transradial cardiac catheterization
2. Age ≥ 18 years
3. Ability to provide written informed consent

Exclusion Criteria:

1. Absence of written informed consent
2. Patients on long-term systemic anticoagulation therapy for a different indication
3. Patients requiring a heparin dose of greater than 50 units per kilogram before, during, or after the procedure for any reason.
4. Patients requiring greater than 6 French catheter access
Physiotherapy of the Pelvic Floor in Women With Deep Infiltrating Endometriosis

The aim of our study is to evaluate the impact of pelvic floor physiotherapy in symptomatic patients affected by deep infiltrating endometriosis, using 3D/4D transperineal ultrasound for evaluation of pelvic floor morphometry, NRS (Numerical Rating Scale) for evaluation of symptoms and validated questionnaires investigating intestinal, sexual and urinary functions.

These results will be compared with those obtained from symptomatic patients affected by deep infiltrating endometriosis following the standard care procedure that does not provide pelvic floor physiotherapy.

Symptomatic, nulliparous women with deep infiltrating endometriosis are included in the study.

During the first medical examination, endometriosis related symptoms are assessed using NRS (Numerical Rating Scale); intestinal, sexual and urinary functions are evaluated with validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS), Female Sexual Function Index (FSFI), Bristol Female Lower Urinary Tract Symptoms (BFLUTS)); pelvic floor morphometry at rest, during pelvic floor contraction and during Valsalva manoeuvre is evaluated using 3D/4D transperineal ultrasound through the assessment of the levator hiatus area (LHA). Gynaecological examination, transvaginal and transabdominal ultrasound are performed.

After the first medical examination, enrolled patients are randomized into two groups: patients in Group A receive standard care procedure and pelvic floor physiotherapy; patients in Group B receive standard care procedure only. Pelvic floor physiotherapy protocol consists of six sessions (weeks 1, 3, 5, 8, 11 from the randomization). After four months from the first medical examination, endometriosis related symptoms, intestinal, sexual and urinary functions and pelvic floor morphometry are reassessed for all patients, using the same procedures, comparing the two groups and evaluating the impact of pelvic floor physiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical and ultrasound diagnosis of deep endometriosis with related symptoms (chronic pelvic pain, dysmenorrhea, dyschezia, dyspareunia, dysuria)
* Nulliparity
* Obtaining Informed Consent

Exclusion Criteria:

* Patients with an oncological disease or needing surgery for malignant pathologies
* Urogenital prolapse
* History of surgery for deep infiltrating endometriosis
* Congenital or acquired malformations of pelvis and pelvic floor
* History of diseases characterised by chronic pelvic pain (interstitial cystitis, irritable bowel disease, chronic vulvodynia).
Study With Heparin Sodium in Intravenous Administration

The purpose of this phase I study is to know the pharmacodynamic profile in in intravenous application in humans of the sodium heparin of porcine origin of the company União Química, building from the pharmacodynamic data generated its pharmacokinetic profile, due to the dosage limitation of heparin directly in biological samples. In addition, the toxicity of the product will be evaluated in healthy male participants.

This stage of product development follows the guidelines of the ANVISA (National Health Surveillance Agency) Heparin Development Guide. Unfractionated sodium heparin is a drug known and widely used in the world for over half a century, thus, no unknown adverse events or any risk of administration are expected in humans, however, this is the first human Biological product developed by União Química. The proposed development of this biological drug follows the individual route, the control heparin used in the present study has the objective of evaluating the results found with the test product, without the obligation to demonstrate bioequivalence among the evaluated products.

Eligibility Criteria:
Inclusion Criteria:

* Eligible healthy participants should sign the Informed Consent Form,
* be between 18 and 60 years of age,
* be male,
* present a BMI ≥ 18.5 and ≤ 29.9 kg / m2,
* be characterized as a voluntary (Normal physical examination)
* no history of current or recent diseases.

Exclusion Criteria:

* hemoglobin \<12 g / dL;
* Platelets \<100 x 109 / L;
* Regular or last 30 days use of anticoagulant medications;
* Current or past use of anti-inflammatory or anti-platelet medications;
* History of gastrointestinal bleeding;
* History of venous thrombosis, pulmonary embolism, coagulopathies or any coagulation disorder;
* Any other chronic illness or regular use of drugs that at the discretion of the investigator contraindicates participation in the study,
* serious comorbidity (at the discretion of the researcher) of any nature that could compromise participation in the study or put the participant at risk considered to be unacceptable,
* Laboratory that at the discretion of the investigator contraindicates the participation of the participant in the study;
* Hypersensitivity or contraindication to the components of the medications studied, participation in another clinical study in less than 1 year (unless justified by the investigator)
* donation of blood (\> 500 mL) in the preceding 3 months.