cyrilzakka/clinical-trials huggingface dataset:
The Effect of the Ultrasound-guided Serratus Anterior Plane Block in Combinaison With Thoracic Paravertebral cathéter Versus Thoracic Paravertebral Cather for Perioperative Analgesia in Thoracic Surgery

Introduction

The paravertebral catheter has been shown to be effective in controlling postoperative pain, but has never been associated with the deep dentate block in thoracic surgery. The objective of this study was to compare the efficacy of single-dose deep dentate block-level postoperative pain control in combination with a continuous perfusion paravertebral catheter versus continuous perfusion paravertebral catheter alone in controlled thoracic surgery.

Materials and methods

We retrospectively included 159 ASA I-III major patients who underwent scheduled thoracic surgery in the operating theater of Dijon University Hospital, between March and November 2018. All patients benefited from the same anesthetic protocol routinely used in controlled thoracic surgery. They were included in two groups: deep serrate deep group (GS) with a deep serrated deep serrate block immediately after orotracheal intubation with 0.2% Ropivacaine at 0.75 mg / kg and paravertebral catheter placed by the surgeon and put in charge at the fall of the surgical drapes versus control group (GC) benefiting from a paravertebral catheter alone. The primary endpoint was 24-hour morphine equivalent consumption. The criteria for secondary judgments were intraoperative remifentanil consumption, VAS at 0h, 24h and 48h, morphine consumption at 0h, 48h and the profile of the various complications. The morphine equivalent was calculated according to an equivalence table with reference to Oxycodone per os. Quantitative data are presented in median and standard deviation and were compared by Student's t-test or Wilcoxon test.


Eligibility Criteria:
Inclusion Criteria:

* We included all patients over the age of 18 who met the classification criteria of the American Society of Anesthesiology (ASA) and had thoracic surgery in the operating theater of Dijon University Hospital

Exclusion Criteria:

* Exclusion criteria were ASA 4 or higher, pregnant or breastfeeding women, minor patients, patients not able to use morphine PCA, and patients with chronic algia.
High-intensity Focused Ultrasound in Treatment of Uterine Fibroid

Uterine fibroids are common uterine benign neoplasm. They can cause abnormal menstrual bleeding, pelvic discomfort and urinary frequency. Although surgical intervention is the definitive treatment, some women prefer to have their uterus preserved. High-intensity focused ultrasound (HIFU) therapy is receiving increasing interest in the management of uterine fibroids by inducing focal thermocoagulation of the fibroids. Results obtained by various research groups have shown that HIFU treatment is safe, effective and is highly acceptable to patients. The main objective of this study is to evaluate the therapeutic efficacy of HIFU in the treatment of uterine fibroids.

In this proposed study, 20 patients who have symptomatic uterine fibroids who meet the study inclusion criteria will be invited to participate in the study which involves the use of HIFU in the management of the fibroid. Background information of the patients such as age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical disease will be collected. Subjects will also be asked to complete an eight-item section of a Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) which evaluate the effect of the fibroid on the quality of life of women.


Eligibility Criteria:
Inclusion Criteria:

* Age \>40 years old, with no future childbearing plans
* Age \>30 years old, who has tubal sterilization
* Significant fibroids symptoms
* Clinical uterine size less than 20 weeks gestation
* Dominant fibroid less than 10 cm in diameter without areas of necrosis as judged by contrast MRI
* No laparotomy scars
* Women should be able to give consent

Exclusion Criteria:

* Other pelvic or uncontrolled systemic diseases
* Confirmed or suspected pregnancy
* Patients who are contraindicated for MRI examination
* Patients with thick abdominal wall (\>5 cm, as measured by MRI)
* Presence or history of acute pelvic inflammatory disease
* History of lower abdominal surgery, known severe pelvic endometriosis and/ or extensive pelvic adhesion
* Cervical fibroids, subserous or submucous fibroids with pedicle, \<3.5 cm posterior wall fibroid, fibroids suspicious of malignancy (rapidly growing)
Parental Real-life Experience During the Neonatal Transfer

The transfer of newborn child from Intensive Care Unit to maternity is very stressfull for parents.This anxiety could have repercussion on parents adaptation on their new environment, on parent's role and also on their relaional interaction with the baby. As StJoseph hospital receives an important number of premature babies, the neonatology service aim to evaluate the real life experience of mothers during the transfer to set up improvement axes with hospital departments upstream.


Eligibility Criteria:
Inclusion Criteria:

* new born child transfered to St Joseph neonatology service
* Having stayed at least five days Intensive Care Unit
* Regardless of the term
* have to stay at least five days in neonatology

Exclusion Criteria:

* Non francophones parents
* Duration of predictable hospitalization of less than 5 days
Effect of Timing Progesterone Luteal Support on Embryo Transfer

The study aims to know whether starting progesterone luteal support in intra cytoplasmic sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of embryo transfer compared with starting luteal support on day of embryo transfer

Double blind Randomized Controlled Trial (RCT) : the clinicians and the patents were blinded of the allocation group.

A total of 137 embryo transfers were randomly allocated into either arm I (67 ) starting luteal support as daily IM injections of 100 mg prontogest on day of egg retrieval , or arm II (66) starting the same P4 dose on day of embryo transfer

Eligibility Criteria:
Inclusion Criteria:

* first ICSI trial, normal uterus, normal cervix, normal ovarian response ,easy mock transfer,patient consenting

Exclusion Criteria:

* age over 38, difficult mock transfer, low and high ovarian response, patient not consenting
Reimbursement Effects on Enrollment in Obesity Treatment

The purpose of this study is to simulate what would occur if insurance reimbursement became available for obesity treatment but required that the individual meet defined performance milestones.

This is a prospective study to determine whether a reimbursement incentive (the prospect of reimbursement of half of the out-of-pocket fee for participation in the UAB EatRight Weight Management Program, when it is contingent upon consistent Program participation and loss of 6% of initial body weight) is associated with (1) a higher rate of Program enrollment and (2) greater percent weight loss, greater reductions in medication dosages and costs, and fewer visits to health care providers after 12 weeks and 9 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults with obesity (BMI at least 30 kg/m2)
* Commitment of the full EatRight Weight Management Program fee

Exclusion Criteria:

* None
Arterial Spin Labeling Blood Flow Magnetic Resonance Imaging for the Evaluation of Response to Therapy in Metastatic Renal Cell Carcinoma

The purpose of this study is to assess magnetic resonance imaging (MRI) as a tool to track tumor growth for renal cell carcinoma while participants are on clinical treatment therapy of sunitinib and AMG386. An MRI is a type of scan that uses powerful magnets to make clearer images or to focus on detailed medical information in the abdomen and pelvis. The imaging done for this study will use the arterial spin labeling (ASL) MRI technique that allows us to see blood flow changes which possibly may indicate changes in tumor growth. Participants will be on a clinical trial for the treatment.

All participants must be enrolled on protocol, "Collection of Specimens and Clinical Data from Patients with Renal Cell Carcinoma Treatment with Targeted Therapies", about to start a treatment course with sunitinib and AMG386, and willing to come in for successive MRIs at the following times: baseline, 2 weeks upon initiation of therapy with sunitinib and AMG386, after cycle 2 and/or cycle 4 of therapy, and at the end of your study therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Patients diagnosed with metastatic renal cell carcinoma and who will initiate therapy with the combination of sunitinib and AMG386 as either their first anti-angiogenic therapy or after failure of prior cytokine therapy
* Enrolled on protocol 06-105, "Collection of specimens and clinical data from patients with renal cell carcinoma treated with targeted therapies"
* Found to have tumors that are \>/=2.5 cm as determined by CT imaging
* Candidate lesions for ASL MRI should be \>/= 2.5cm. Order of preference of lesion location will be as follows: abdominal lesions, bone lesions and chest lesions

Exclusion Criteria:

* Subjects will be excluded from the study if they have a contraindication to MRI which may include the following: Pacemaker, MRI incompatible metal implant, recently implanted vascular clip, history of claustrophobia, metal fragment within the eye
Efficacy of Supporting SAFE Early Intervention

Within the scope of the study, it was planned that risky babies would be treated with the SAFE early intervention approach for 10 weeks after they were discharged from the intensive care unit. Neurodevelopmental Treatment was applied to the control group. Sensory, motor and language development of the babies were evaluated before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

Neurologically and developmentally risky infant (such as premature birth, hypoxia, infection, hypoxic ischemic encephalopathy),

Having a NICU history of 15 days or more,

Exclusion Criteria:

congenital malformations, metabolic and genetic disease musculoskeletal system anomaly
Post Market Clinical Follow up Study With the Cervical Disc Prothesis MOVE®-C

Study design: International, prospective, multicentre, non-randomised, observational study according to § 23b MPG.

Objectives: Observational study to confirm the safety and performance of the cervical disc prosthesis MOVE®-C.

This clinical investigation is conducted to gain post market results on the Cervical Disc Prosthesis MOVE®-C and to demonstrate the safety and performance. Besides, it is aimed to gain knowledge concerning the development of patients' quality of life (QoL) after the implantation of the Cervical Disc Prosthesis MOVE®-C and to collect data for the analysis of the range of motion (ROM), which is an essential parameter for motion-preserving implants.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of discopathy or disc hernia with radiculopathy or stenosis of the foramen and spinal canal,
2. documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated,
3. no surgical treatment regarding the planned index surgery within the last six weeks prior implantation,
4. unsuccessful conservative medical care regarding the indication within the last six weeks,
5. age ≥18 years,
6. patient must agree to fully participate in the clinical trial and give informed consent in writing,
7. patient is capable to realise the nature, aims and possible consequences of the clinical trial (MPG §20.2.1),
8. patient information has been provided and all written consents of the patient are available.

Exclusion Criteria:

* Known contraindication against the use of cervical intervertebral disc prostheses in accordance with the manufacturer's instructions for use:

  1. Bone mineral density with T-score ≤ -1.5 as determined by spine DXA if male ≥ 60 years of age or female ≥ 50 years of age,
  2. active systemic infection or infection at the operative site,
  3. sustained osteoporotic fracture of the spine, hip or wrist,
  4. spinal metastases,
  5. known allergy to titanium or polycarbonate-urethane,
  6. confirmed pregnancy,
  7. severe cervical myelopathy,
  8. patients requiring a treatment that destabilises the spine (e.g. posterior element decompression),
  9. advanced cervical anatomical deformity at the operative site (e.g. ankylosing spondylitis, scoliosis),
  10. advanced degenerative changes (e.g. spondylosis) at the index vertebral level,
  11. patient is kept in an institution under judicial or official orders (MPG §20.3).
Haploidentical Donor Hematopoietic Progenitor Cell and NK Cell Transplantation for Hematologic Malignancy

In this study, participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA) matched related/sibling donor (MSD) or matched unrelated donor (MUD) identified, will receive a haploidentical donor HCT with additional natural killer (NK) cells.

The investigators anticipate enrollment of 75 donors and 75 recipients.

PRIMARY OBJECTIVE:

* To estimate the rate of successful engraftment at day +42 post-transplant in patients who receive haploidentical donor stem cell plus NK cell transplantation with TLI based conditioning regimen for high risk hematologic malignancy.

SECONDARY OBJECTIVES:

* Estimate the incidence of malignant relapse, event-free survival, and overall survival at one-year post-transplantation.
* Estimate incidence and severity of acute and chronic (GVHD).
* Estimate the rate of transplant related mortality (TRM) in the first 100 days after transplantation.

Donors will undergo G-CSF mobilization of peripheral blood stem cells (PBSC) prior to undergoing two apheresis collections of hematopoietic progenitor cells (HPC,A) and one apheresis collection of therapeutic cell product of purified natural killer cells (TC-NK).

The HPC products will be T-cell depleted (TCD) using the investigational CliniMACS device. CD34+ enrichment and CD45RA depletion will be utilized on sequential HPC grafts.

Participants will undergo a preparative regimen of total lymphoid irradiation, fludarabine, cyclophosphamide, granulocyte colony stimulating factor (G-CSF), thiotepa, and melphalan. This is followed by infusions of donor cells that have been prepared using the CliniMACS system: HPC,A (CD34+ selected), HPC,A (CD45RA depleted), and TC-NK.

Eligibility Criteria:
Inclusion Criteria - Transplant Recipients:

* Age less than or equal to 21 years.
* Does not have a suitable MSD or volunteer MUD available in the necessary time for stem cell donation.
* Has a suitable single haplotype matched (≥ 3 of 6) and family member donor.
* High risk hematologic malignancy.
* If prior CNS leukemia, it must be treated and in CNS CR
* Does not have any other active malignancy other than the one for which this HCT is indicated.
* No prior allogeneic HCT, and no autologous HCT within the previous 12 months.
* Patient must fulfill pre-transplant evaluation

Inclusion Criteria - Haploidentical Donor:

* At least single haplotype matched (≥ 3 of 6) family member
* At least 18 years of age.
* HIV negative.
* Not pregnant as confirmed by negative serum or urine pregnancy test within 14 days prior to enrollment (if female).
* Not breast feeding.
* Regarding eligibility, is identified as either: (1) Completed the process of donor eligibility determination as outlined in 21 CFR 1271 and agency guidance; OR (2) Does not meet 21 CFR 1271 eligibility requirements, but has a declaration of urgent medical need completed by the principal investigator or physician sub-investigator per 21 CFR 1271.
Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease

* The primary objective of this study was to characterize the pharmacokinetics (PK) of alglucosidase alfa manufactured at the 4000 L scale in participants who had a confirmed diagnosis of Pompe disease.
* A secondary objective of this study was to evaluate and explore the relationship between anti-recombinant human acid alpha-glucosidase antibody titers and the PK of alglucosidase alfa.

The total study duration per participant was 4 to 8 weeks that consisted of a screening period (from 2 days to 4 weeks), treatment visit (1 day), and a follow up call (greater than or equal to 30 days). Two participants enrolled prior to protocol amendment 2 (dated 17 December 2015), which changed the study to single-dose, and were treated for 26 weeks, with a 4-week follow up.

Eligibility Criteria:
Inclusion Criteria:

A participant was to meet all of the following criteria to be eligible for this study:

* The participant and/or the participant's parent/legal guardian was willing and able to provide signed informed consent.
* The participant had a confirmed acid alpha-glucosidase (GAA) enzyme deficiency from skin, blood, or muscle tissue and/or 2 confirmed GAA gene mutations.
* Infant and toddler Pompe disease participants could be included in the study only under condition (minimal body weight) that the trial-related blood loss (including any losses in the maneuver) would not exceed 3 percent (%) of the total blood volume during a period of 4 weeks and would not exceed 1 % at any single time.
* The participant, if female and of childbearing potential, must have had a negative pregnancy test (urine beta-human chorionic gonadotropin) at screening. Note: All female participants of childbearing potential and sexually mature males must have agreed to use a medically accepted method of contraception throughout the study.
* For participants previously treated with alglucosidase alfa the participant had received alglucosidase alfa for at least 6 months.

Exclusion Criteria:

A participant who met any of the following criteria was excluded from this study:

* The participant was participating in another clinical study using an investigational product.
* The participant, in the opinion of the Investigator, was unable to adhere to the requirements of the study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
TRANSFORM - Observational Cohort Study of Darbepoetin Alfa Use in European Union (EU) Hemodialysis Patients Switched From PEG Epoetin Beta

To describe the time course of hemoglobin concentration in EU hemodialysis patients switched from methoxy polyethylene glycol-epoetin beta (PEG epoetin beta; Mircera) to darbepoetin alfa (Aranesp).

This is a multi-centre, observational cohort study of EU hemodialysis patients whose erythropoiesis stimulating agent (ESA) therapy has been switched from PEG epoetin beta to darbepoetin alfa. Data will be collected for the period spanning 14 weeks prior to switch through to 26 weeks post-switch.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age. CKD diagnosis, receiving hemodialysis
* Received PEG epoetin beta for 14weeks prior to switching to darbepoetin alfa and received at least one dose of darbepoetin alfa.
Comparison of Treatment Success of Botox Injection in the Internal Sphincter Versus Isosorbidedinitrate Ointment in Patients With an Anal Fissure

The standard treatment of anal fissure in the netherlands (ISDN ointment) is being compared to a relatively new treatment (injection of Botox in the internal anal sphincter). The study hypothesis is that after 4 months, Botox has healed more patients than ISDN. The comparison is done blinded for the surgeon and the patient.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic

Exclusion Criteria:

* pregnancy
* previous anal surgery
* Crohn's disease
* systemic causes of an anal fissure
A New Tool for Automatic Ovarian Follicle Count and it Abilities to Evaluate Ovarian Reserve

The ultrasound unit in Meir Medical Center developed new software to automated ovarian follicle count on the basis of 3D US. The investigators intent to evaluate this software at two steps:

* To compared the abilities of the software to physician follicle count.
* To evaluate with the software the antral follicle count, as expression to ovarian reserve at 3 different time of the month.

The investigators believe that the software measurement of the small follicle can be better than the common antral follicle count that is use today, and by this accurate evaluation of the small follicle the investigators can evaluate the ovarian reserve at any time of the mount, and not only at the early follicular phase that use today.

Antral follicle count (AFC) is one of the methods to evaluate ovarian reserve. But this method is not that straightforward with a lot of inter and intra observe variation. In attempt to overcome this problems we going the verified a new software for automated AFC.

At the first step we will compare the human count and the software count of the AFC in 150 exams of ovaries at 3D US.

At the second step we will use the software to evaluate ovarian reserve at 50 women before fertility treatment. This woman will be questioned about epidemiologic data (age, ethnicity, medical history) and evaluate at the early follicular phase with blood test for follicle stimulating hormone, luteinizing hormone , E2, anti-mullerian hormone , Prolactin, thyroid-stimulating hormone, Testosterone, Progesterone, 17-hydroxyprogesterone, dehydroepiandrosterone-Sulphate. The evaluation of the AFC by US will be at early follicular phase, late follicular phase and mid luteal phase

Eligibility Criteria:
Inclusion Criteria:

* woman under age 40 years all
* woman at evaluation before beginning of fertility treatment
* woman with regular menstrual cycle

Exclusion Criteria:

* woman who treat with ovulation induction