cyrilzakka/clinical-trials huggingface dataset:
Effects of External Leg Compression Devices on Healing and Blood Clotting

This study aims to compare two different external calf compression devices applied in healthy individuals. These devices are commonly used in medical care in order to prevent the formation of blood clots, for example during immobilization after surgery. We aim to confirm the effects of external cyclic compression on healing and blood clotting and also to identify the one which is more effective.

Aims:

1. To confirm that IPC (intermittent pneumatic compression) has a positive effect on systemic coagulation status, tissue metabolic activity, collagen formation and tissue microcirculation.
2. To compare the above effect of two different IPC devices: one rapid calf-IPC which expels blood from the veins sharp and rapidly and one slow calf-IPC, which pumps the blood in a more gentle and progressive way. This study could also make implications on how the blood flow parameters could be interpreted in the clinical setting, as previous haemodynamic studies have explained the superiority of the rapid device in terms of peak velocity and the superiority of the slow device in terms of total ejected volume per individual stimulus.

Materials and Methods: 10-15 healthy individuals are planned to be recruited. The subjects will be lying in a prone position. A cuff connected with a Calf-IPC device will be wrapped around each calf and will be functioning for 120 minutes. Microdialysis catheters will be inserted with the tips about 1 mm from the volar side of each Achilles tendon. In addition, one adhesive sensor will be applied on each calf just distal to the lower part of the cuff, in order to measure tissue oxygen mixed saturation (INVOS). Blood samples will be taken via a venous catheter in antecubital fossa just before the application of the IPC, and at 30, 60 and 120 minutes. From the serum, several systemic coagulation factors will be measured (tissue plasminogen activator (tPA), plasminogen activator inhibitor type 1 (PAI), tissue factor pathway inhibitor (TFPI), D-dimer, von Willebrand factor and factor VIIa). From the microdialysis diffusate , two groups of substances will be measured: a) metabolites, such as pyruvate and b) collagen macromolecules, such as procollagen type I and III.

The ultimate goal is to assess the role of different IPC patterns on deep venous thrombosis prevention and promotion of tissue healing.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals
* Male gender
* Age 18-60

Exclusion Criteria:

* Smoking
* Severe cardiovascular or renal disease causing pitting oedema
* Previous operation in the lower limbs affecting the vascular or lymphatic system
Mucopolysaccharidosis (MPS) I, II, and VI Screening in a High-Risk Population With Previous Surgical Repair or Presence of Inguinal and/or Umbilical Hernia in Combination With Pediatric ENT Surgery (The HATT Project)

Mucopolysaccharidosis (MPS) type II (MPS II; Hunter syndrome) is a rare, X-linked disease caused by a deficiency of the lysosomal enzyme iduronate-2-sulfatase (I2S) and occurs almost exclusively in boys, with an incidence of approximately 1.3 per 100,000 live male births.1 Early identification of MPS II is challenging because some initial features, such as chronic runny nose, otitis media, and hernias, are commonly seen in the general population. As a result, even though the signs and symptoms of MPS II typically appear early in childhood, the diagnosis may lag behind by several years.

The primary objective of this international multi-center study is to evaluate the positive screening rate of MPS II subjects by screening a high-risk male pediatric population who have had or are scheduled for 1 or more specific ENT surgical procedures (adenoidectomy and/or tonsillectomy and/or tympanostomy) and who have a previously repaired or present evidence of an inguinal and/or umbilical hernia.

With evidence-based information from MPS registries regarding the types of surgical interventions that are most prevalent in MPS, this screening study is expected to provide the understanding of the role pediatric ENT surgeons can play in identifying young children with MPS.

Eligibility Criteria:
Inclusion Criteria:

Each subject must meet the following criteria to be enrolled in this study:

1. The subject is male.
2. The subject is \<7 years of age.
3. The subject has had or is scheduled for ENT surgery for any of the following, alone or in combination: adenoidectomy, tonsillectomy, and tympanostomy.
4. The subject has record of previous surgical repair or presence of inguinal and/or umbilical hernia.
5. The subject's parent(s) or the subject's legally authorized representative(s) has provided written informed consent that has been approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC).

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

1. The subject has a current confirmed diagnosis of any MPS disorder.
2. The subject was born prematurely (defined as born before 37 weeks gestation).
3. The subject has received a blood transfusion within the past 6 weeks.
4. The subject has received a bone marrow transplant.
Impact of Yogotherapeutics on Chronic Pains' Patients

In a context where yoga is more and more popularized in France and in Europe, and where Yogatherapy (as complementary medicine) begins to make its place in the care of patients in French hospitals, it seems interesting to study the impact of yoga in the chronic pain patient treated in a specific pain consultation by this non-pharmacological approach, and accessible.

Yoga is a discipline that has its origins in India for nearly 5,000 years, and which aims to bring physical, mental and spiritual well-being through postures, stretching, breathing exercises and meditation.

Non-invasive and having very few side effects, this approach allows the practitioner to reclaim their body, to know themselves better, to accept their limits, to respect them and to empower themselves in their care and pathology.

More and more studies are now looking at the positive effect of yoga whether it is on stress by demonstrating the drop in cortisol in participants, or on the reduction of symptoms of depression, improvement of immune function, or pain.

To our knowledge, no study of the impact of yoga for analgesic treatment has been carried out in France.

Through this retrospective study, the investigators wish to demonstrate a reduction in pain and / or an improvement in the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old,
* Seen in consultation for chronic pain with implementation of Yogatherapy,

Exclusion Criteria:

* Patient \< 18 years old,
* No indication for Yogatherapy treatment (Severe cognitive disorder / Major unbalanced psychological disorder),
* Trauma pathology and / or acute fracture in progress,
* Patient refusal to participate.
Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis

The aim of this observational study is to compare Dimethyl fumarate (DMF) and Teriflunomide on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from French Observatory of Multiple Sclerosis (French MS cohort )


Eligibility Criteria:
Inclusion Criteria:

* RRMS Patients with an EDSS score ranging between 0 and 5.5, who initiated either DMF or Teriflunomide before 1/01/2016 and with an available MRI scan and EDSS assessment respectively within 12 and 6 months before treatment initiation Patients who had consent to OFSEP registry Naive patient or treated with prior first line treatment : interferon, glatiramer acetate

Exclusion Criteria:

* Patient with progressive multiple sclerosis
* Patients with prior second line Patient with no MRI or EDSS score within the year before DMF or Teriflunomide initiation.
Brain Involvement in Dystrophinopathies Part 1

The objective of this study is to collect data from a large cohort of individuals with DMD and BMD focusing on the neurobehavioural aspects of these conditions and their correlation to the location of the DMD gene mutation.

Intellectual disability and neurobehavioural comorbidities affect at least 50% of the individuals with Duchenne muscular dystrophy (DMD), which, although a rare genetic disease, is the most common form of muscular dystrophy in childhood. Several studies have documented that 25% of the DMD population has intellectual disability with recent studies suggesting that autism and clinically relevant hyperactivity affects 20% and 25% of DMD boys respectively. A milder allelic variant, named Becker muscular dystrophy (BMD), has similar prevalence in the population and is also associated with variable degrees of central nervous system (CNS) comorbidities, which however have been less well defined.

The investigators will address these deficiencies in a large multicentre study funded by the European Commission (EU H2020) involving 6 countries (Denmark; The Netherlands; France; Spain; Italy and UK) with the largest European neuromuscular centres and advocacy groups. The aim will be to study the neurobehavioural aspects of DMD and BMD as well as their correlation to the genotype. This study will involve male participants with DMD aged 5-17 years and with BMD aged 5-50 years. It will comprise of online questionnaires that will be completed either by a parent of a participant \<17 years or an adult participant. The questionnaires take approximately 70 minutes to complete, however this can be done in multiple sittings. Currently there is a lack of information to assist the prognosis of CNS comorbidities, as existing databases and registries typically focus on the motor milestones and physical disability of these patients. There is therefore, an urgent need to present the course and outcomes in DMD and BMD patients with a wide range of DMD mutations, to provide information at the point of diagnosis and onwards for families, clinicians and service providers. It will also assist in paving the way to greater biological understanding and personalization of interventions.

Eligibility Criteria:
Inclusion Criteria:

For DMD patients:

* Male
* age 5-17 years
* genetically-proven diagnosis of DMD
* genetic mutation that abrogates expression of Dp427 alone (assigned in DMD Group 1: Dp427-/Dp140+) or both Dp427 and Dp140 (assigned to DMD Group 2: Dp427-/Dp140-); or all isoforms (assigned to DMD group 3)

For BMD patients:

* age 5-50 years
* genetically-proven diagnosis of BMD
* genetic mutation that decreases expression of Dp427 alone (assigned to BMD Group 1), of both Dp427 and Dp140 (assigned to BMD Group 2), or of all the isoforms (assigned to BMD group 3).

Exclusion Criteria:

* Lack of a molecular diagnosis of DMD or BMD
* Mutation falls outside the regions of interest
* A severe co-morbidity or planned surgical intervention within 6 months from the study which could interfere with the well-being of the participant
Combination of Ibuprofen, G-CSF and Plerixafor as Stem Cells Mobilization Regimen in Patients Affected by X-CGD

This is a phase II exploratory study conducted to evaluate the safety and efficacy of the combination of Ibuprofen, G-CSF and Plerixafor as stem cell mobilization regimen in patients affected by X-CGD.

We designed a mobilization trial with the aim of collecting a sufficient number of HSPC in X-CGD patients; it is well known that this procedure is challenging for these patients, potentially due to functional defects induced by their chronic inflammatory state.

The combination of G-CSF and Plerixafor is considered state of the art for HSPC harvest in gene therapy trials; we considered to add a non-steroidal inflammatory drug to increase HSPC mobilization and reduce inflammation that could have a role in altering HSPC content.

If this trial confirms the synergistic effect of the three drugs under investigation, such a regimen will be considered for a HSPC mobilization in future gene therapy trial for X-CGD patients.

Eligibility Criteria:
Inclusion Criteria:

* Genetic diagnosis of X-CGD
* 18-45 years of age
* Karnofsky Index \> 80 %
* Adequate cardiac, renal, hepatic and pulmonary function.
* Negative thrombophilic screen and negative history for previous thrombotic events
* Written informed consent

Exclusion Criteria:

* Previous Bone Marrow Transplantation or previous Gene Therapy.
* Use of other investigational agents within 4 weeks prior to study enrolment (within 6 weeks if use of long-acting agents).
* Ongoing IFN-γ treatment (within 4 weeks).
* Symptomatic inflammatory bowel disease.
* Symptomatic viral, bacterial, or fungal infection within 6 weeks of eligibility
* Neoplasia (except local skin cancer) or history of "familial" cancer
* Myelodysplasia or other serious hematological disorder
* History of uncontrolled seizures and deep venous thrombosis
* Other systemic disease judged as incompatible with the procedure
* Positivity for HIV and/or HCV RNA and/or HbsAg and/or HBV DNA
* Active alcohol or substance abuse within 6 months of the study.
* Contraindications to IBU, G-CSF, Plerixafor or Pantoprazole administration
Isolated Fetal Splenic Cyst : Prenatal Diagnosis and Postnatal Evolution

The aim of this study was to describe prevalence, radiologic and ultrasound evolution during pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst

The aim of this study was to describe prevalence, radiologic and ultrasound evolution during pregnancy, postnatal evolution and treatment strategy in case of isolated fetal spelnic cyst. The investigators performed a retrospective study in the Montpellier Prenatal Diagnosis Centre between 2007 and 2017. All pregnant women referred to this unit after routine ultrasound examination with a suspected splenic cyst were included. Participant all benefit a reference ultrasound to perform a detailed morphological examination. In any doubt about diagnosis, a MRI exam wad proposed. Then patient were followed regularly. At birth, all newborn babys had medical examination to search early complication. Then, children had a surgical consultation and regular ultrasound examinations were performed.

Eligibility Criteria:
Inclusion Criteria:

* Pregnent women with an isolated suspected fetal splenic cyst between 2007 and 2017 in Montpellier Prenatal Diagnosis Center

Exclusion Criteria:

* All others fetal diagnosis
The Impact of Ozone Gel on the Bone Height and Density

Purpose: The present study was conducted to evaluate the effect of using ozone gel with maxillary sinus elevation using tenting technique on the clinical and radiographic outcome of implants placed simultaneously..

Materials and Methods: A total of 30 sinuses with an average residual alveolar bone height ranging from 4-7 mm participated in this randomized controlled clinical trial. After closed sinus lift operation, patients were randomly and equally allocated into control group and ozone gel recipient group. Cone beam computed tomography was performed immediately and at 4 months postoperatively. Bone stability was measured immediately and at 3 \&amp; 4 months postoperatively. Bone height and stability were evaluated radiographically, and bone stability was measured using the Osstell device.

Concern over biological augmentations used in bone healing has grown in recent years. One of the essential demands in sinus lifting procedure is to speed up the bone formation and enhance the quality of the formed bone in the space created after sinus elevation. Since more than 100 years medical grade ozone has been used as one of the non-medication methods of treatment. E. A. Fisch in the 1930's was the first dentist to use ozone therapy in his practice to aid in disinfection and wound healing. Current ozone uses a mixture of ozone gel and pure oxygen, with today's medical ozone generators which regulate the flow of medical grade O2 through high voltage tubes which is capable of producing pure ozone-oxygen mixtures in precise dosages.

Nevertheless, there is not enough evidence to support the use of ozone in oral and maxillofacial surgery. Ozone therapy has a therapeutic effect that promotes blood and growth factor supply, aids in wound healing, and may improve bone regeneration . However up till now, no studies were conducted to assess the impact of using ozone gel on bone formation in case maxillary sinus elevation.

Eligibility Criteria:
Inclusion Criteria:

* Patient age should be \&gt; 18 years of age.
* Patients included were ASA I and ASA II.
* Both males and females were included in the study.
* Patients with need of tooth replacements in the maxillary premolar and molar area where the residual alveolar bone height ranges from 4-7 mm and bone density D3 or D4.
* Compliance with all requirements in the study and signing the informed consent.

Exclusion Criteria:

* Patients with immunological diseases or diseases affecting bone healing.
* Patients suffering from uncontrolled systemic diseases.
* Patients with active acute infection related to the planned implant site, maxillary sinusitis or pathosis.
* Patients with parafunctional occlusal habits.
* Patients with bad oral hygiene.
* Patients who were alcohol and drug abusers.
* Heavy Smoker Patients.
* Patients who went previous sinus lifting surgery.
Vaginal Cuff Closure by Modification of the Bakay Technique in Total Laparoscopic Hysterectomy

Modified Bakay technique offers a novel colpotomy and cuff closure technique for total laparoscopic hysterectomy (TLH), and consists of placing a single continuous running purse-string suture facilitating the cuff closure before colpotomy. The modified Bakay technique adds a standard apical compartment support and has the potential to facilitate the primary healing of the vaginal cuff. This study aimed to compare the surgical and clinical outcomes of the Modified Bakay technique to conventional standard technique in patients undergoing TLH.

The basis for minimizing the rate of severe haemorrhage and ureteral injuries, the most serious events related to these steps, is meticulous dissection providing a clear operative field and the skill and experience of the surgeon. In total laparoscopic hysterectomy (TLH), the altered anatomy after the removal of the uterus may cause the retraction of vagina and shifting of neighbouring structures such as bladder and/or bowel to this pouch, thereby, leading to obstruction of the operative field for vaginal cuff closure.

Bakay published his novel colpotomy and cuff closure technique for TLH. It was the first to describe placing a single continuous running purse-string suture facilitating the cuff closure before colpotomy. The main advantage of the technique involved retrieving the safe suture margins required for vaginal cuff closure before the pelvic anatomy was altered by the removal of the uterus.

In addition to this advantage, we modified the technique to achieve a better cuff healing and standardized apical support and the modified Bakay technique (MT) proposes:

i) placing a single continuous running purse-string suture for vaginal cuff closure before the pelvic anatomy is altered by the colpotomy and removal of the uterus;

ii) suspension/plication of USLs (as a well-defined, efficient, concomitant apical support procedure to prevent future vaginal vault prolapse) routinely in each case before colpotomy while the margins of these ligaments and adjacent structures such as ureters are still prominent and pelvic anatomy is not altered; and

iii) using cold-knife colpotomy instead of electrosurgical colpotomy to support the primary healing of the vaginal cuff. In the present study, we aimed to compare the surgical and clinical outcomes of the MT to standard technique (ST) in patients undergoing TLH.

Eligibility Criteria:
Inclusion Criteria:

* Patients who needed laparoscopic hysterectomy

Exclusion Criteria:

* Patients with anaesthetic contraindications to laparoscopy
* premalignant or malignant genital disease
* prior pelvic and/or abdominal radiotherapy
* large adnexal masses; large fibroids obscuring the visualization of the cervicovaginal junction
* Suspicion of malignancy
* Pelvic organ prolapse Stage \>2
BEAST: A Pilot Trial

This pilot study trial will test the acceptability, feasibility, and usability of a brief enhanced anxiety sensitivity treatment to reduce anxiety sensitivity and functional impairment in Veterans.

This study tests a treatment with two components: first, there is a single session face-to-face virtual intervention delivered by the counselor or therapist via VA Video Connect software. Second, a mobile app (mPRO) is used for EMA and to deliver EMI components.

Veterans will be enrolled following informed consent. The research staff will read the measures to the Veteran who will verbally provide their answers.

Veterans will next complete the baseline assessment. At the baseline assessment, Veterans meet with the Project Coordinator by phone or virtually to complete a consenting process, guidance on the video software being used, and set-up and guidance on use of the mobile app.

Following the baseline assessment, participants will be scheduled to receive the face-to-face virtual intervention followed by two weeks of EMA/EMI via mPRO.

At the end of the two weeks, Veterans will complete a post-intervention assessment appointment. The post-intervention assessment includes an exit interview for participants to provide additional feedback regarding acceptability of the intervention.

Follow-up assessment appointments will be completed at the 1-month and 3-month follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Are English-speaking
* Score equal to or greater than 9 on the SSASI indicating elevated anxiety sensitivity
* Score equal to or greater than 5 on the WHODAS 2.0

Exclusion Criteria:

* Veterans with cognitive impairment as measured scoring equal to or greater than 11 on the Blessed
* Orientation-Memory-Concentration Test
* Veterans without access to a smartphone
* Veterans with significant medical or psychiatric conditions that may limit participation, including:

  * severe documented schizophrenia
  * an ongoing active psychotic or manic state
  * an imminent suicide crisis will be excluded from our study and provided the appropriate referral
A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis

This is a Phase I multicenter study that will be conducted in the United States and Europe.


Eligibility Criteria:
Inclusion Criteria:

* RA diagnosed according to the American College of Rheumatology (ACR)

Exclusion Criteria:

* Female patients who are pregnant, plan to become pregnant during the study, or are breastfeeding
* Clinically significant abnormal ECG
* History of anaphylactic reactions
* Positive hepatitis C antibody or hepatitis B surface antigen
* Positive serology for human immunodeficiency virus (HIV) by quantitative polymerase chain reaction
* A history of an autoimmune disease other than RA (other than secondary Sjogren syndrome)
* Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty syndrome
* Malignancy, or prior malignancy, other than non-melanoma skin cancer, or cervical carcinoma in situ that has been resected
* Recent administration of a live, attenuated vaccine, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
* Concomitant therapy with a biologic agent
* Recent exposure to any investigational agent
* Any current or recent signs or symptoms of infection requiring parenteral antibiotic administration
* Hospitalization for a clinically relevant event within the 4 weeks prior to screening