cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of Three Different Embryo Transfer Media in ICSI Cycles

The study design is a prospective randomized uncontrolled clinical trial. It will include 150 cases.

The aim of this study is to compare the efficacy of three different media used for embryo transfer regarding "chemical and clinical" pregnancy rate, implantation rate and ongoing pregnancy and miscarriage rates in IVF and ICSI cycles.

The three different embryo transfer media are:

1. Hyaluronan-enriched medium "Embryo Glue®"
2. 30% Protein-supplemented Culture medium "Global Total®"
3. Autologous Follicular Fluid (a Novel technique) In order to establish the optimal media for embryo transfer

Two or three embryos will be transferred at day 5 after ovum pick-up (OPU).

The patients will be divided randomly (closed envelop method) into 3 groups:

* Group A (50 patients): embryos will be transferred using a medium supplemented with 0.5 mg/mL of hyaluronic acid (EmbryoGlue®, Vitrolife, Sweden) for 20 minutes before intrauterine transfer took place
* Group B (50 patients): embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada) for 20 minutes.
* Group C (50 patients): a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid for 20 minutes.

Follicular fluid will be collected in a sterile procedure, centrifuged for 20 minutes in an embryo test tube. The supernatant will be removed in a sterilized technique then heated to 56°C for 30 minutes then filtered through 0.22 micron filter. Gentamycin sulphate will be added at a concentration of 10 µg/mL then the liquid is preserved in a normal freezer.

Defreezing follicular fluid will be performed at day-1 before embryo transfer. The follicular fluid will be warmed to room temperature. Preparation of embryo transfer media will be performed as usual, will be covered with paraffin oil (Ovoil®, Vitrolife, Sweeden) and then incubated overnight in 7% CO2, 9% O2, 22% N2.

All embryo transfers will be performed using an embryo transfer catheter (Labotect catheter, Labotect GmbH, Germany).

Number of embryos transferred will be according to ASRM guideline 2013 on day 5 after ovum pick-up (OPU).

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-35 years
2. Body mass index (BMI): ≤ 30
3. Anti-mullerian hormone (AMH): 1.1 - 3
4. No gynecological problem e.g. fibroid, endometriosis, uterine polyp, hydrosalpinx or adenomysis
5. Male factor: mild to moderate oligo or asthenospermia

Exclusion Criteria:

1. Age: \<18 years or \>35 years
2. Body mass index (BMI): \>30
3. Anti-mullerian hormone (AMH): \<1.1 or \>3
4. gynecological problem e.g. fibroid, endometriosis, uterine polyp, hydrosalpinx or adenomysis will be excluded
5. Male factor: Abnormal sperm morphology; (globozoospermia and pin-point sperm) and azoospermia; (whether obstructive or non-obstructive) will be excluded
6. Patients with recurrent implantation failure
Outcome, Hindsight and Implicit Bias in Emergency Medicine and Medical Disciplinary Law.

Background Hindsight bias and outcome bias may play an important role in retrospective law of errors in Emergency Medicine and may affect judgement. In addition, differences in sex and medical history may affect treatment decisions (implicit bias).

Aims First, to assess if and to what extent knowledge of an outcome may affect the ability of Emergency Physicians and physicians with experience in disciplinary law to determine the quality of care given. Secondly, to investigate whether a medical history with nonspecific/functional/somatoform complaints and sex differences affect clinical decision making in Emergency Physicians.

Study design and analyses A web-based cross-sectional survey using vignettes with six clinical scenarios (four vignettes for outcome/hindsight bias, four vignettes for implicit bias). The survey was sent to all Emergency Physicians and residents in training in the Netherlands. Four scenarios were also sent to physicians with experience in disciplinary law. In four vignettes, participants received a scenario without an outcome, or with a positive or negative outcome. They were asked to rate the quality of care provided as sufficient or insufficient and, in more detail, poor/below average/average/good/outstanding and how likely they thought it would be that the patient would have had a negative outcome (in percent). In the other two vignettes, participants received one vignette describing a scenario of a patient presenting to the ED with acute abdominal pain and one vignette describing a scenario with chest pain. The sex and medical history differed among the participants (e.g. male/female, nonspecific medical history/somatic medical history). Participants were asked whether they would prescribe pain medication, and whether they would do diagnostic imaging.

Importance and impact This research may help to understand the impact of knowing the outcome in retrospective laws in Dutch Emergency Physicians and physicians with experience in disciplinary law. If outcome and hindsight bias are present, retrospective judgement may need a different approach in medicine, i.e. blinding judges for the outcome, to prevent wrong justice and adverse effect on clinicians well-being. Also, if implicit bias in sex and medical history is present, a training programme is needed to reduce certain bias and to improve equality in the provided care.


Eligibility Criteria:
Inclusion Criteria:

* Emergency physicians or residents, General practitioners, and physicians with experience in disciplinary law.

Exclusion Criteria:

* others
Study of CPI-100 in Patients With Advanced Tumors

This is a prospective, open-label, 2-arm, non-randomized study of CPI-100 in patients with advanced tumors. CPI-100 is administered via intravenous infusion in a 3 + 3 study design to identify the maximum tolerated dose (MTD).

Primary Objectives:

• To determine the safety, tolerability and maximum tolerated dose (MTD) of CPI-100 as once every two weeks (Q2W) and once every three weeks (Q3W) regimens in patients with advanced tumors

Secondary Objectives:

* To evaluate the pharmacokinetics (PK) of CPI-100
* To evaluate clinical response and resolution of symptoms after CPI-100 treatment
* To characterize adverse events of CPI-100 monotherapy and CPI-100 in combination with capecitabine in patients with advanced cancers

Up to 5 dose levels of CPI-100 Q2W, 4 dose levels of Q3W regimen of CPI-100 monotherapy (Q3W Arm A) and 4 dose levels of Q3W regimen of CPI-100 in combination with capecitabine (Q3W Arm B) will be tested in a dose escalation study. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intravenous injection of CPI-100 within 28 days (Q2W) or 42 days (Q3W):

* Grade 4 or greater treatment related adverse events
* Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (including nausea, vomiting or diarrhea lasting more than 72 hours)

Eligibility Criteria:
Inclusion Criteria:

* Have a histologically or cytologically confirmed diagnosis of advanced solid tumor
* Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy
* Be reasonably recovered from preceding major surgery or no major surgery within 4 weeks prior to the start of Day 1 treatment
* Have a negative pregnancy test for females with child bearing age at screening and should not be breast feeding
* Be willing to abstain from sexual activity or practice physical barrier contraception from study entry to 6 months after the last day of treatment

Exclusion Criteria:

* Have peripheral neuropathy of Grade 3 or Grade 4 at screening
* Have peripheral sensory neuropathy of Grade 2 or greater at screening
* Have an interval from previous neurotoxic drugs less than 3 months unless reasonably recovered from all grades of neurotoxicity to grade 1 or lower as judged by the investigator
* Have known hypersensitivity to chemotherapeutic agents
* Have a history of thrombocytopenia with complications including hemorrhage or bleeding \> Grade 2 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe
* Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia
* Is pregnant or breast-feeding
Irreversible Electroporation(IRE) For Unresectable Portal Venous Tumor Emboli

The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Portal venous tumor emboli.

By enrolling patients with unresectable Portal venous tumor emboli adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for unresectable Portal venous tumor emboli.

Eligibility Criteria:
Inclusion Criteria:

* Liver cancer diagnosed by positive biopsy or non-invasive criteria,
* Liver cancer with Portal venous tumor emboli,
* Not suitable for surgical resection or transplantation,
* Child-Pugh class A,B
* Eastern Cooperative Oncology Group (ECOG) score of 0-1,
* A prothrombin time ratio \> 50%,
* Platelet count \> 80x10\^9/L,
* Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
* Able to comprehend and willing to sign the written informed consent form (ICF),
* Have a life expectancy of at least 3 months.

Exclusion Criteria:

* Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
* Any active implanted device (eg Pacemaker),
* Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
* Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
* Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Comparison of Robot-assisted Donornephrectomy vs Hand-assisted Laparoscopic Donornephrectomy

The aim of this retrospective study was to analyze donor and recipient outcomes after robotic-assisted donor nephrectomy and hand-assisted laparoscopic donornephrectomy.

Living donor kidney transplantation is superior to cadaveric kidney transplantation because of the better patient and graft survival rates, better cost-effectiveness and improved quality of life of the recipient. According to the current guidelines, the laparoscopic technique of donor nephrectomy is now recommended as "the preferential technique". The advantages of the hand-assisted laparoscopic donor nephrectomy (HALDN) as compared with the conventional laparoscopy include tactile feedback, less kidney traction, rapid kidney removal and a shorter warm ischemic period. HALDN is nowadays the most frequently used technique in the U.S. for living donor nephrectomy. The laparoscopic techniques may have helped to increase the expansion of the donor pool. However, laparoscopic surgery have some disadvantages especially ergonomic inconveniences for the surgeon, which may result in decreased surgeons' performance and musculoskeletal disorders. Surgical robotics can play a role in extending surgical careers, by allowing surgeons to perform high volume laparoscopic surgery in a more ergonomic way. Robotic assistance in living donor nephrectomy can offer improved safety by enhanced control, accuracy, stability, and vision. The aim of this retrospective study was to compare the robotic assisted donor nephrectomy (RADN) with the HALDN technique with respect to donor and recipient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adult, healthy condition

Exclusion Criteria:

* Children, not suitable for kidney donation
Evaluate the Interest of the Pre-conceptional Endometrial Immune Profiling to Increase Birth Rates

A prospective, randomized, controlled, open two-arm study to evaluate the interest of the pre-conceptional endometrial immune profiling to increase birth rates.

Birth rates following an embryo transfer with a mean of two embryos transferred stagnate around 23% per transfer (annual report of the Agency of Biomedicine). Some estimates that half of infertile patients treated are partially or totally concerned by problem of inadequate uterine receptivity.

The investigators' hypothesis is that a pre-conceptional immune endometrial evaluation may increase significantly birth rates since successful implantation results from both the matching of a competent embryo within a competent endometrium.

The identification of endometrial biomarkers documenting the immune uterine environment during the implantation window would be able to improve the efficacy of ART through a personalization of treatment accordingly to the ability of the patients to receive their embryos. All patients with all inclusion criteria and no exclusion criteria will be included. Only patients with a deregulation (immune analysis) will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* Infertile patients will be included at the beginning of their medical care in reproduction once the indication to perform either an IVF with or without ICSI has been established. The indication for IVF will be: tubal infertility, endometriosis, ovarian dysovulation with failure of intra-uterine insemination, idiopathic infertility The indication for ICSI will be: male infertility (oligo-astheno-teratospermia), previous failure of oocytes fertilization in IVF
* Patients should be younger than 38 years old (Age \< 38)

  * with a normal ovarian reserve (AMH\>1.5ng/ml, FSH\<10 IU/l on day-3, antral follicles count (AFC) over 6 on day-3 of the cycle by ultrasound)
  * The range of the IVF or ICSI attempt should be lower than 3 or equal at 2 (first or second IVF/ICSI). If a live birth occurred in the past by IVF/ICSI, the range of the new attempt is 1.
* With a signed informed and consent form
* With medical insurance

Exclusion Criteria:

* Azoospermia or cryptozoospermia (Patient's partner)
* IVF/ICSI attempt scheduled in another ART unit
* Contraindication to any experimental treatment (Cortancyl, Intralipids, Human Chorionic Gonadotropin)
* Maternal serology positive for hepatite C or B
The Use of Armeo Spring in Upper Extremity Rehabilitation

The purpose of this study is to evaluate the use of the Armeo®Spring Pediatric as therapy for children with hand and arm weakness. The Armeo®Spring Pediatric is a device that supports the weight of the child's arm and uses joystick that helps to play computer games. The child will be assessed before and after this therapy. Participating children with upper extremity impairments will receive therapy 3x/week for 6 weeks during 30-45 minutes sessions at progressively increasing degrees of difficulty. Each child's performance will be tracked with regard to time necessary to complete a predetermined number of trials of the activity. The standardized assessment tools that will be used are the Assisting Hand Assessment (AHA), Box \& Blocks test, Jebsen Taylor hand function test, and the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). Data will be analyzed to determine the efficacy of this training method.

8. "Adverse Events" All serious adverse events will be reported to the IRB immediately, but no later than \[5\] days of the occurrence or receipt of notification from an outside source; the IRB can make changes to the consent form as a result of adverse events. Any such event will be reported to the IRB on the "Adverse Event Report." \[See attachment.\] 9. "Debriefing" Debriefing is not required because there is no deception of subjects involved or there are no alternative treatments or procedures used in a "blind" fashion.

10. "Intervention" Participants in this study are children who present with a diagnosis of upper extremity weakness or involvement secondary to various reasons. These children receive occupational, physical, and/or speech services at St Mary's Hospital for Children. The children participating in this program will be receiving their occupational therapy session with the use of the Armeo®Spring Pediatric. They will also continue to receive their regular physical and speech therapy session. Once the program is completed, they will continue to receive their regular occupation therapy sessions.

11. "Confidentiality" Data sheets will be coded with a number to represent each child. The numeric data obtained regarding timed trials will be entered into a computer which is password-protected at St. Mary's Hospital for Children in Bayside, NY. Consent forms with the child's name and parental signatures and video tape or photographic images recorded during data collection will be stored in accordance with St. Mary's Hospital for Children patient privacy policy.

Eligibility Criteria:
Inclusion Criteria:

* Age between 7 -17 years.
* Arm weakness secondary to various causes.
* Armeo®Spring Pediatric fit
* Upper arm measures:155mm-235mm (7 to 9.5 inches)
* Lower arm measures: 230mm-370mm (9inches to 14 inches)
* Ability to follow instructions.

Exclusion Criteria:

* Vision deficits
* Contractures that do not allow use of system.
* Spasticity that does not allow use of system.
* Osteopenia
* Recent surgeries to the involved upper extremity.
Protection During Cardiac Surgery.

This trial investigates whether a multimodal cardioprotection per-surgery therapeutic strategy could reduce myocardial injury in patients undergoing cardiac surgery compared to traditional management. The primary endpoint is the AUC (area under the curve) of the hypersensitive troponin I. Blood samples will be collected during the 72 hours following the aortic cross-unclamping. This trial is a French, multicenter, randomized, single-blinded and controlled trial. 210 patients will be enrolled with a clinical follow-up during 30 days.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Aortic valve surgery (aortic valve replacement associated or not with coronary artery bypass graft, Bentall surgery or Tirone David surgery)
* Signed informed consent

Exclusion Criteria:

* Emergency surgery
* Redo surgery
* Patient treated with Nicorandil, repaglinid or sulfonylurea 48 hours prior to surgery
* Low cardiac output requiring catecholamine infusion or circulatory assistance prior to surgery
* Severe renal failure: dialysis or glomerular filtration rate \< 30 mL/min
* Severe liver failure (spontaneous INR \>2)
* Severe respiratory insufficiency (VEMS \<40% of predicted value)
* Contra-indication to sevoflurane and propofol
* Myocardial infarction \< 7 days
* Severe upper limb arterial disease
* Heparin-induced thrombopenia
* Active infection under antibiotic treatment
* Any other surgery combined with the aortic valve surgery: myotomia of Morrow (hypertrophic myocardiopathy), treatment of heart rhythm disorder, inter-atrial communication closure, mitral valve replacement, tricuspid valve replacement, pulmonary valve replacement.
* Pregnant women
* Currently participating in another trial which may interfere with ProCCard results
* Not benefiting from a social insurance or similar system
* Patient under legal protection
Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial

Background:

According to the WHO, major depressive disorder is the second largest healthcare problem worldwide in terms of disability caused by illness. It afflicts an estimated 17% of individuals during their lifetimes at tremendous costs. A number of depressive patients are treated with antidepressant medication. The efficacy of antidepressant medication has been studied in a number of systematic reviews, and in recent years some of these reviews have shown that the efficacy is questionable for many patients. So are there other effective treatments for this serious illness?

Cognitive- and psychodynamic therapies are probably both significantly more effective for depression than no treatment, but only limited comparisons have been made between the two interventions. A Cochrane review shows that cognitive therapy has a preventive effect against recurrent depression, and that this effect may surpass the preventive effect of antidepressant medication. Mindfulness training may be an effective technique in preventing relapse in patients who have had at least 3 previous depressive episodes. But efficacy in treating currently depressed patients has not been studied.

Objective To perform a randomised clinical trial with blinded assessment of efficacy variables in order to study the effects of mindfulness based behavioral therapy (cognitive therapy and mindfulness) versus psychodynamic therapy in depressive patients.

Methods

A randomised clinical trial of 84 consecutive patients diagnosed with major depressive disorder, referred to the day clinic, Roskilde psychiatric services. The patients will be randomised to one of two interventions:

1. MIBT (mindfulness-based behavioural therapy)
2. PT (psychodynamic therapy)


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 65 years
2. Major depressive disorder (SCID I).
3. BDI II \> 13.
4. Written informed consent.

Exclusion Criteria:

1. Current psychosis, diagnosis of schizophrenia or schizotypal personality disorder (DSM IV-TR).
2. Alcohol or substance abuse judged to require treatment in preference to depression (assessed during patient conference).
3. Commenced or changed psychopharmacological treatment less than six weeks before randomisation.
4. Pregnancy.
5. No written informed consent.
Histological Analysis of Peri-implant Soft Tissue

The aim of this study is to evaluate the histologically analysis in humans and the orientation of collagen fibers around screw-less, morse taper implant-abutment connection.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older, affected by partial edentulism of posterior elements need for at least two single implant rehabilitations
* able to understand a sign an informed consent

Exclusion Criteria:

* Peapole having a systemic or local contraindications for implant placement;
* Untreated periodontal disease;
* smokers;
* osteoporosis;
* uncontrolled diabetes;
* refusal to implant rehabilitation;
* refusal to biopsy collection;
* systemic pathologies that could compromise the healing of peri-implant tissues.
Estimation of Cardiac Output in Neonatal ICU Using an Ultrasound Dilution Technique

Presently there is no apparatus, clinically available, for routine determination of cardiac output (CO) in children. The goal of this research is to develop new technology that will help determine CO in neonates.


Eligibility Criteria:
Inclusion Criteria:

* All neonatal patients cared for in our ICU with umbilical venous and arterial catheters simultaneously in place for their care, will be eligible.

Exclusion Criteria:

* Patients would be excluded if the family/guardian denied permission or if the attending physician felt the patient was not stable.