cyrilzakka/clinical-trials huggingface dataset:
Effects of Fascia Therapy Versus Facial Manipulation on Neck Pain

This study a randomized clinical trial to determine the effects of fasiatherapy versus facial manipulation on pain, range of motion and function in patients with chronic neck pain. A sample of 52 patients will be taken and divided into two groups each with 26 patients. Group A will receive DBM fasciatherapy along with conventional physical therapy while group B will receive fascial manipulation along with the conventional physical therapy protocol. The conventional physical therapy protocol will include hot pack, neck isometrics and stretches. The session will be around 45 to 60 min on each patient with three session per week on alternate days. A total of three-week treatment regime will be given to the patients and assessment of patient's pain, range of motion and function with NPRS (numeric pain rating scale), goniometry and NDI (neck disability index) will be done at the baseline, after the completion of treatment at three weeks and after 6 weeks to observe the long-term effects. The data will be analyzed using SPSS.

Chronic neck pain is one of the most common musculoskeletal disorder among general population. Like muscular spasm of neck that can cause neck pain, fascial adhesions are also the common cause of neck pain. Fascia is a form of connective tissue that is made up of collagen, surrounds the body parts and also resist tissue tensile load. Fascial injury and adhesions are common and can lead to pain, restricted motion and swelling. The treatment of the fascial injury is necessary to relieve those symptoms. There are many treatments for the chronic neck pain and this study focuses on two new treatment techniques for the fascial pain. The first is the Dannis Bois method fasciatherpy which is a manual approach that focuses on the structural segmentation of fascia and involves the application of gentle pressure while stretching the body's connective tissues. The other treatment technique is the fascial manipulation method that involves the treatment which is directed to specific fascial adhesions. The current study is novel in a way that there is limited literature about DBM fasciatherapy versus fascial manipulation on chronic neck pain. Both methods were employed to see if they improve ranges along with accompanying pain and disability.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Age 18-40 years
* Chronicity of pain - 6 months minimum

Exclusion Criteria:

* Post-op patient
* Any bony, soft tissue or systemic disease
* Pregnant females
* Radiculopathy
Epidural Anesthesia in Acute Pancreatitis

Acute pancreatitis is a common urgency with a mortality rate of up to 30% , decreased blood flow in the pancreatic microcirculation. It seems to be the main cause of the pathophysiology of acute pancreatitis. Today, there have been many attempts in the management of pancreatitis but no established management seems to be ideal. The epidural block is an anesthetic technique used to provide highly peri and post-operative analgesia, also plays an important role in improving the gastrointestinal vascular perfusion (due to sympathetic blockade that this technique produces) so this anesthetic technique is proposed as an alternative to both clinical treatment as an analgesic for acute pancreatitis.

The main objective of the study is to evaluate the therapeutic effects of epidural block in patients with acute pancreatitis, comparing day hospital stay among patients receiving intravenous analgesic treatment and patients who are undergoing epidural block.

It is a (prospective, comparative, longitudinal, experimental, randomized) controlled clinical trial. They include patients who are diagnosed with acute pancreatitis at the Naval General Hospital of High Specialty. Two groups were taken by random assignment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute pancreatitis
2. Patients who agree to participate in the study

Exclusion Criteria:

1. Patients who do not agree to participate in the study
2. Patients who experience any absolute contraindication to epidural block
3. Patients with platelet counts below 80,000 mcl
4. Patients with data gastrointestinal or urinary bleeding
Descriptive Study of a Cohort of Orbital Solitary Fibrous Tumors

Orbital solitary fibrous tumors are rare tumors with an intermediate potential of malignancy. Orbital solitary fibrous tumors' prognostic criteria are still poorly understood.

Some patients with orbital solitary fibrous tumors have been treated at the Adolphe de Rothschild Foundation Hospital. This cohort will be studied to describe the recurrence rate and to identify predictive factors of recurrence or metastasis.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated at the Adolphe de Rothschild foundation hospital for an orbital solitary fibrous tumor between 01/01/2014 and 09/30/2020

Exclusion Criteria:

* Opposition of the patient (or of the relative if the patient is deceased)
* Patients benefiting from a legal protection measure
* Pregnant or breastfeeding woman
Epidemiological Study on Invasive Bacterial Diseases

Streptococcus pneumoniae (pneumococcus), Neisseria meningitidis (meningococcus), and Haemophilus influenzae (hemophilus) are among the main bacteria responsible for invasive bacterial diseases (MBIs) that result in severe clinical pictures also characterized by a high frequency of serious complications. Surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiologic trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.The present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies.

Pathogen identification by culture methods has been shown to be unsatisfactory, as antibiotic therapy carried out in patients before hospitalization prevents bacterial culture development and subsequent typing in many cases. In addition, technical problems due to sample collection, storage and transport reduce germ viability leading to false negatives in pathogen identification by culture methods. In contrast, molecular diagnosis allows germ identification on biological samples even in the absence of germ viability, thus enabling more accurate diagnosis.

Surveillance of infections caused by these pathogens and their distribution by serotypes/serogroups is essential to guide public health interventions, assess epidemiological trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.In 2006, the AOU Meyer Immunology Laboratory received a grant from the National Center for Disease Prevention and Control (NCDC) to develop a molecular diagnostic method for surveillance of invasive infections with Neisseria meningitidis (meningococcal,) Streptococcus pneumoniae (pneumococcus) and Haemophilus influenzae (hemophilus) that would allow identification of the germ on biological samples even in the absence of germ viability, with a view to improving surveillance, prevention and treatment strategies. The project involved performing molecular diagnostic tests on samples from patients referred to hospitals in the Tuscany Region and outside the region. The present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus MBI

Exclusion Criteria:

* Other type of bacterial infections.
A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants

The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, superiority study comparing the efficacy and safety of rivaroxaban with placebo for primary prophylaxis of venous thromboembolism (VTE) in ambulatory adult participants, with various cancer types who are scheduled to initiate systemic cancer therapy. The study consists of 3 Phases: Screening Phase (14 Days), double-blind treatment Phase (180 Days) and follow up Phase (30 Days). The duration of participation in the study for each participant is approximately 32 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Have histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
* Have a Khorana thromboembolic risk Score greater than or equal to (\>=) 2
* Creatinine clearance (CrCl) \>= 30 milliliter per minute (mL/min)
* Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care

Exclusion Criteria:

* Diagnosis of primary brain tumors
* Known history of brain metastases
* Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
* Hematologic malignancies with the exception of lymphoma
* Platelet count less than (\<) 50,000/millimeter\^3 (mm\^3), Life expectancy of less than or equal to (\<=) 6 months
Smartphone Rehabilitation App For Stroke Survivor

This is a pilot study of a smartphone app in which the tool will be developed and validation of the tool will be done for the rehabilitation of upper limb in stroke survivors. The study will be divided into two phases. The first phase will be the development of a smartphone app for upper limb function. The second phase of the study will be a pilot study where 10 stroke patients will be recruited and upper limb intervention will be applied through a smartphone app.


Eligibility Criteria:
Inclusion Criteria:

* Subacute and chronic stroke patient \> 3 months post stroke till 1 year.
* Modified Ashworth scale scoring ≤ 2
* An ability to understand the command
* First ever stroke
* Grade II, III on Functional mobility Scale
* Able to use and comprehend smart phone.

Exclusion Criteria:

* Vestibular disorders, paroxysmal vertigo
* Presence of other neurological conditions such as neglect, hemianopsia and pushing syndrome
Comparison of Two Automated Mononuclear Collection Systems in Patients Undergoing Extracorporeal Photochemotherapy. A Cross-over Equivalence Study. (MNC_CMNC)

In a study performed in 2012, the investigators demonstrated that in ECP setting , the new automated device (Spectra Optia-MNC) released by Terumo BCT for MNCs collection based on intermittent flow is safe and ensures high-quality MNC collection and yield.(5, 6) More recently (in 2013), Terumo BCT released another automated system that allows to collect stem cells and MNCs basing on a continuous collection flow.(7, 8) The aim of this cross-over study is to compare yield (i.e. collection efficiency, CE) and quality (i.e. purity and contamination) of MNCs collected from patients undergoing ECP with two different automated systems: MNC and CMNC (Terumo BCT) processing 1.5 blood volumes during every collection procedure.

Two-sequences-in-four-periods cross-over, with the same patients randomized to both devices within each ECP cycle in two consecutive cycles, open-label.

Cycle 1 Cycle 1 Cycle 2 Cycle 2 Day 1 Day 2 Day 1 Day 2 Sequence A CMNC MNC MNC CMNC Sequence B MNC CMNC CMNC MNC There might be some carry over effect between procedure 1 and 2 within each cycle, because during the procedure the patient is administered fluids, and therefore cell counts/ml in the second day might be lower than in the first day; this it is intrinsic to the clinical procedure and can not be modified, but will be taken into account in statistical analyses. Carry over effect between first and second cycle is not expected, since they are performed at least 7 days apart; this allow the patient's cell blood count to be restored to baseline values; however, this will also be considered in statistical analyses.

Eligibility Criteria:
adult (\>18 years) patients undergoing extracorporeal photochemotherapy for either CLAD or GvHD Inclusion criteria: age \>18 years on extracorporeal photochemotherapy for either CLAD or GvHD exclusion criteria: age \<18 years,
Decreasing Postoperative Blood Loss and Seizures by Timing of Intravenous Tranexamic Acid 2 Pilot Trial

The goal of this clinical trial is to establish the feasibility of conducting a large trial to determine the optimal timing of intravenous tranexamic acid administration in cardiac surgery. The main questions it aims to answer are:

* Is it feasible to conduct a larger definitive trial?
* Can we measure the systemic tranexamic acid concentration and fibrinolytic potential in the blood samples?

Researchers will compare intravenous tranexamic acid administered before cardiopulmonary bypass versus after cardiopulmonary bypass to see if the systemic tranexamic acid concentration and fibrinolytic potential are similar or better.

Participants will:

* Provide written informed consent
* Receive tranexamic acid during surgery
* Provide blood samples at 5 time points: before surgery, on arrival in intensive care unit, 3 hours after arrival, 6 hours after arrival, and on the next morning.

Postoperative bleeding related to open cardiac surgery increases the rates of complications and mortality. It results from the blood thinners that are needed for use. Intravenous tranexamic acid (TxA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TxA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TxA and the brain tissues. The aim is to eliminate the risk of seizures and to improve the protection against bleeding. When TxA is used before and during cardiopulmonary bypass (CPB), the presence of systemic TxA during de-airing of the heart and the termination of CPB may facilitate entry of TxA into the brain causing seizures. Administration of TxA after CPB may result in higher systemic concentrations that may be more effective for protecting against bleeding after surgery. The aim is to establish the feasibility of a definitive trial to prove that administration of TxA after CPB can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age
2. Undergoing a cardiac surgical procedure (i.e., isolated CABG, isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass
3. Provide written informed consent

Exclusion Criteria:

1. Allergy to tranexamic acid
2. Fulfill any of the following transfusion risk factors (A-F):

   A. Emergency surgery B. History of bleeding disorder C. Inherited thromboembolic or hemorrhagic disease D. Infective endocarditis (active) E. Pre-operative thrombocytopenia (\&lt;50,000 platelets per µL) F. Pre-operative hemoglobin \&lt;110 g/L
3. Estimated glomerular filtration rate \&lt;30 mL/min (CKD-EPI equation) or on dialysis
4. Pre-operative hemoglobin \&gt;170 g/L
5. Expected circulatory arrest
6. Pregnancy or breast feeding
7. Previous enrollment in DEPOSITION trial
8. Refusal of blood products (e.g., Jehovah's Witnesses)
9. Isolated Pericardiectomy
Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)

The PRIMER (Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy) trial is a pilot designed to estimate the feasibility of integrating a home-based pre-operative exercise and mindfulness program (pre-habilitation program) for patients scheduled to undergo radical cystectomy for bladder cancer in an attempt to improve both physical and psychological conditioning pre-operatively.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥18 years of age
* Good surgical candidate determined by treating surgeon
* Histologically documented muscle invasive urothelial carcinoma of the bladder, high-risk non-muscle invasive bladder cancer, non-muscle invasive bladder cancer refractory to BCG, cisplatin ineligible muscle invasive bladder cancer receiving upfront cystectomy, urothelial carcinoma of the bladder with variant histology
* Adequate Organ Function per protocol definition
* ECOG performance status ≤2
* Received medical clearance to complete cardiopulmonary exercise testing
* Willing to use the personal or study provided devices for monitoring and performing the exercise routines.
* Fluent in English or Spanish for the EORTC QLQ questionnaire
* No known contraindications to high intensity exercise

Exclusion Criteria:

* Contraindications to participating in aerobic exercise
* Currently participating in an aerobic exercise program
* New onset chest pain nor dyspnea with exertion
* Histologically documented micropapillary or sarcomatoid bladder cancer
* Distant metastatic carcinoma
Effect of Platelet Rich Plasma and Keratinocyte Suspensions on Wound Healing

This prospective randomized trial evaluated the impact of autologous keratinocytes suspended in platelet concentrates on healing skin graft donor site wounds. It was hypothesized that the treatment would speed and improve wound healing.


Eligibility Criteria:
Inclusion Criteria:

* Skin graft donor sites total surface \< 15% BSA
* Skin graft donor site size: 0.2mm deep, 30 to 40 cm2 surface area

Exclusion Criteria:

* Patients treated with immunosuppressors
* Patients treated with corticoids
* Patients suffering from terminal renal insufficiency
* Patients suffering from severe peripheral arteriopathy
Predictors of the Response to Adalimumab in Rheumatoid Arthritis

Rheumatoid arthritis (RA) is the most common inflammatory rheumatic disease which is characterized by joint inflammation (clinical involvement), by osteo-cartilaginous lesions (structural damage) and generally by bone involvement. All those features lead to great disability. Because it represents a major problem of the public health care system, RA has been selected as one of the main objectives of the government for the next five years.

RA patients who do not respond to DMARDs require a treatment by TNF-a blocking agents. However, no information is available to predict the clinical, structural and bone responses to those new drugs that can be responsible of severe side-effects. Moreover, they are particularly expensive since their yearly cost is estimated between 75000 and 112500 k euros for the G4 region.

The purpose of the present research project is to determine potential predictive factors of the response to a new TNF-a blocker ie adalimumab. To address this question, several investigations will be performed including measurement of different blood markers, particularly bone markers, well-defined autoantibodies and new autoantibody populations identified by proteomic analysis, large-scale analysis of gene expression with cDNA arrays from blood mononuclear cells, and use of different imaging tools.

The criteria of judgement will be the clinical, structural and bone responses to those new agents.

This study requires the recruitment of about 100 patients receiving adalimumab for a 1-year period.

At the end of the study, we hope to identify predictive factors of the response to adalimumab, which will lead to a better management of this TNF-a blocker. Indeed, they will be prescribed only for the patients who are likely to respond to those drugs. Thus, this study should allow to elaborate theranostic algorithms. Such an approach will have great benefits for the patients: more rapid efficacy, less severe side-reactions and lower costs.


Eligibility Criteria:
Inclusion Criteria:

* ACR classification criteria of RA
* DAS 28 \> 5.1
* inadequately controlled by at least one DMARD
* biologics naïve

Exclusion Criteria:

* exclusion criteria of adalimumab and methotrexate (regulation authorities)
Value of Advanced MRI Techniques in the Assessment of Endometriosis

Endometriosis is a common gynaecological disease, mostly in women of reproductive age, with a prevalence of about 10 %, which is defined by the presence of endometrial-type tissue outside the uterine cavity. Endometriosis is usually limited to the abdominal and especially the pelvic cavity, extra-abdominal lesions are rare. Within the pelvis it shows a wide variety of locations predominantly affecting the ovaries and the uterus or the peritoneum, uterine ligaments and other pelvic structures. Traditionally, there are three major phenotypes of endometriosis: Ovarian endometrioma (OMA), superficial peritoneal endometriosis (SPE), and deep infiltrating endometriosis (DIE). A lesion is considered a DIE, if it shows infiltration deeper than 5 mm into the peritoneum. The ectopic endometrial implants may induce inflammatory processes, causing scar tissue formation, adhesions, and consequently pelvic anatomy distortion.

The prospective study aims to investigate the value of advanced MRI techniques to improve the assessment of pelvic endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo clinically indicated MR imaging for endometriosis evaluation.

Exclusion Criteria:

* Non-MRI compatible devices/implants