cyrilzakka/clinical-trials huggingface dataset:
Close Collaboration and Discharge Readiness

This prospective non-randomized controlled before-after comparison study aims to evaluate the effects of the Close Collaboration with Parents, a family-centered care intervention for NICU staff, on parents of the newborns in the neonatal intensive care unit (NICU). We focus on (1) family centered care of the NICU rated by parents, (2) parental anxiety symptoms, and (3) their discharge readiness.

The intervention is planned to be implemented between December 2023 and December 2024.

The investigators will collect data from parents whose newborns are admitted to the NICU before and after the intervention and compare the two groups. In most cases, the parents of the two groups belong to different cohorts.

Study period Pre-intervention data collection phase: September 2023 - December 2023 (Planned) Intervention phase: January 2024 - December 2024 (Planned) Post-intervention data collection phase: January 2025 - April 2025 (Planned)

Outcome measures Primary outcome: Quality of family centered care rated by parents Secondary outcomes: Parental anxiety symptoms and parental discharge readiness

Data management Eligible infants and their information will be identified and collected by research team members and entered into the excel file (.xlsx). Data will be pseudonymized when the data is entered into the excel file. All electronic data will be destroyed 10 years after the initiation of the study.

The principal investigator will be responsible for managing access to the data. We do not have a plan to make the data open in the future.

Statistical analysis The comparison between two continuous variables will be carried out by the student t test and, additionally, the multiple linear regression model and the logistic regression model to adjust the effect of the potential confounders. The potential confounders included in the models will be the length of stay and parents' previous mental illness.

R and RStudio will be used to analyze the data.

Eligibility Criteria:
Inclusion Criteria:

* Infants who have been admitted to the NICU for 2 weeks or longer

Exclusion Criteria:

* Infants whose parent doesn't have Japanese as their mother tongue
* Infants whose parent needs psychiatric consultation after birth
Derivation and Validation of a Combination of BOSTON Score and DES-OSA Score for Selection of OSA Patients.

Derivation and Validation of a combination of BOSTON score and DES-OSA score to exclude OSA or to confirm OSA in patients.

The aim of this study is to derive and to validate a combination of BOSTON score and DES-OSA score.

Firstly, the investigators will use a retrospective cohort of 400 patients to determine this combination. It will allow classifying patients in 3 groups: 1) patients for whom OSA can be excluded with certitude, 2) patients for whom OSA can be diagnosed with certitude, and 3) an intermediate group.

Secondly, the 100 patients included in this study will serve to validate the cutoff of the abovementioned combination into a new population.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted in the Clinique Saint-Luc of Bouge for a polysomnography

Exclusion Criteria:

* Patient's refusal
Interest of High-dose Gentamicin Cement Associated With Clindamycin in Changes of Hip and Knee Prostheses

A hip or knee prosthesis can be cemented or not. The team of orthopedic surgeons from the CCOM (Centre de Chirurgie Orthopédique et de la Main) has been cementing all hip and knee prosthesis poses for many years using gentamycin cement as recommended by the French Society of Orthopedic Surgery. and trauma (SOFCOT) (1). Data obtained from the Norwegian Register of Hip Prostheses show that the best survival curve for these prostheses is found for prostheses cemented with gentamycin cement (all causes combined). Independently of the risk of aseptic loosening, infection on the prosthesis is the second complication of arthroplasty. The defense mechanism against pathogens in contact with an implant is the formation of a biofilm. Biofilm bacteria are metabolically inactive and characterized by stationary growth. Due to their slower replication, bacteria in biofilm are up to 1000 times more resistant to antibiotics. Therefore, the optimization of local antibiotic prophylaxis is essential.


Eligibility Criteria:
Inclusion criteria:

* Adult subject (≥18 years old)
* Patient operated on at the HUS between 01/02/2017 and 31/01/2019, for replacement of hip and knee prostheses
* Patient having given their consent for the reuse of their data for the purposes of this research

Exclusion criteria:

- Patient who expressed their opposition to participating in the study
Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients

Studying the effect of laser acupuncture on geriatric patients with rheumatoid arthritis


Eligibility Criteria:
Inclusion Criteria:

* Patients referred from physician (immunologist) diagnosed with rheumatoid arthritis.

Exclusion Criteria:

* Patients having the disease overlapping with other connective tissue diseases, such as systematic lupus erythromatosus and systematic sclerosis.
* History of malignancies.
Masitinib Combined With Isoquercetin and Best Supportive Care in Hospitalized Patients With Moderate and Severe COVID-19

Study objective is to evaluate the efficacy of the combination of masitinib and isoquercetin in adult hospitalized patients with moderate and severe COVID-19.

COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) that is associated with substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or infection with SARS-CoV-2 or therapeutic agent to treat COVID-19.

Many patients with moderate and severe COVID-19, develop a "cytokine storm" that leads to severe pulmonary inflammation and various thrombotic events associated with acute respiratory distress syndrome (ARDS) and potentially death. The combination of masitinib and isoquercetin may prevent the development of these two complications. Masitinib is a potent blocker of mast cells and macrophages that are contributors to the cytokine storm. Isoquercetin inhibits disulfide isomerase (PDI), an enzyme directly involved in the formation of clots, and also decreases D-Dimer, a predictor of COVID-19 thrombosis severity.

The primary objective of this study is to evaluate efficacy of the masitinib and isoquercetin combination in moderate and severe COVID-19 patients. The primary endpoint is subject clinical status at day 15, using a 7-point ordinal scale that is defined as follows: 1. Not hospitalized, no limitations on activities; 2.Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.

Eligibility Criteria:
Inclusion Criteria:

* Has laboratory-confirmed SARS-CoV-2 infection
* Hospitalized patients for the treatment of COVID pneumopathy
* Patients not requiring ICU at admission with moderate and severe pneumopathy according to the OMS Criteria of severity of COVID pneumopathy.
The Use of the Bakri Postpartum Balloon in the Management of Postpartum Hemorrhage Refractory to Conservative Measures

The broad objective of the study is to determine if the Bakri Postpartum Balloon is effective in preventing morbidity and mortality from postpartum hemorrhage (PPH) as part of a standardized management algorithm.

Specific Objectives

* To estimate the rate of morbidity (including operative intervention and peripartum hysterectomy) and mortality secondary to PPH in 4 academic centers after introduction of a standardized protocol for management of PPH, but prior to the inclusion of the Bakri Postpartum Balloon as part of the protocol.
* To estimate the rate of morbidity (including operative intervention and peripartum hysterectomy) and mortality secondary to PPH in 4 academic centers after introduction of a standardized protocol for management of PPH, after the inclusion of the Bakri Postpartum Balloon as part of the protocol.
* To compare morbidity
* To generate preliminary data for (a) a larger confirmatory study of the use of the Bakri Postpartum Balloon in centers with surgical and blood transfusion services, and (b) design of a pilot study of the use of the Bakri device of temporary control of PPH in settings outside of surgical centers (such as by trained midwives or emergency transport personnel).

Phase I: Development and training of staff in standardized algorithm for management of PPH using available local resources (not including Bakri balloon).

Phase II: Data collection after introduction of the standardized algorithm.

Phase III: Revision of protocol to include the Bakri Postpartum Device

Phase IV: Data collection after introduction of the Bakri device

Bakri Postpartum Balloon 510K Premarket Notification/Cook OBGYN #K062438

Eligibility Criteria:
Inclusion Criteria:

* Any woman who recently delivered by either vaginal or cesarean delivery who experiences postpartum hemorrhage, defined as
* Clinically estimated blood loss of greater than 500 ml for a vaginal delivery, or
* Clinically estimated blood loss of greater than 1000 ml for a cesarean delivery, or
* Hemodynamic changes that, in the opinion of the care team, require interventions beyond routine postpartum or postdelivery care (such as intravenous fluids or the use of more than one uterotonic agent).

Exclusion Criteria:

* Minors (less than 18 years of age)
* Arterial bleeding requiring surgical exploration or angiographic embolization
* Cases requiring immediate lifesaving hysterectomy
* Ongoing intrauterine pregnancy
* Cervical cancer
* Purulent infections of the vagina, cervix or uterus
* Untreated uterine anomaly
* Disseminated intravascular coagulation
* A surgical site which would prohibit the device from effectively controlling bleeding
* Patients who are referred for obstructed labor
* Patients with signs, symptoms or other evidence of ruptured uterus
Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals

This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada.

It is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in CD4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.

Eligibility Criteria:
Inclusion Criteria:

1. Documented HIV infection confirmed by western blot or HIV RNA.
2. At least 18 years of age.
3. Less than 1 week of prior antiretroviral therapy.
4. In the opinion of the investigator, patients should be clinically stable. Patients may be on chronic suppressive therapy for opportunistic infections such as MAC or CMV.
5. Patients who are of reproductive potential agree to use an acceptable method of birth control throughout the study. Acceptable methods include an intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence.
6. HIV RNA \> 5000 copies/ml. No restriction on CD4 cell count.
7. A negative urine pregnancy test on the day of initiation of therapy.

Exclusion Criteria:

1. Prior treatment with \>1week of antiretroviral therapy.
2. Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.
3. HIV RNA \< 5000 prior to receiving therapy.
4. Baseline resistance to any of the study regimen drugs on genotype testing.
5. Patients with acute hepatitis due to any cause or clinically significant chronic liver disease.
6. Patient with severe renal insufficiency defined as a calculated creatinine clearance at time of screening \<30mL/min, based on the Cockcroft-Gault equation which is as follows (and 0.85X this value for females): Clcr(mL/min) = (l40-age) x weight (in kg)72 x serum creatinine (mg/dL).
7. Patient has a condition (including but not limited to alcohol or other substance abuse) which in the opinion of the investigator would interfere with patient compliance or safety.
8. A female patient who is pregnant, breast-feeding, or expecting to conceive or donate eggs during the study; or a male patient who is planning to impregnate or provide sperm donation during the study is excluded.
9. Inability to obtain signed informed consent from a patient age 18 or older.
10. Patient has significant hypersensitivity or other contraindication to any of the components of the study drug.
11. Patients who should be treated for hyperlipidemia as per NCEPIII guidelines and patients who are currently receiving lipid-lowering therapy are excluded.
Study of Gemini Rechargeable Spinal Cord Stimulation (SCS) System

The aim of this pre-market, prospective, single-arm, non-randomized, open-label, multi-center clinical study is to collect confirmatory data to show that the Gemini SCS neurostimulation system functions as intended in a clinical setting.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is indicated for an SCS system, or has an implanted SCS system and is scheduled to receive an IPG replacement.
2. Subject is scheduled to receive a new IPG permanent implant and has completed a successful SCS trial in the last 6-months, OR subject is scheduled to undergo an all-in-one procedure OR has an implanted SCS system for an approved chronic pain indication.
3. Subject has a documented NRS pain score of ≥ 6 after at least 5 days without stimulation OR has an implanted functioning SCS system with NRS pain score of ≤ 4.
4. Subject must provide written informed consent prior to any clinical investigation-related procedure.
5. Subject is at least 18 years at the time of enrollment.
6. Subject is capable and willing to recharge an implanted IPG.

Exclusion Criteria:

1. Subject's SCS trial was unsuccessful.
2. Subject is currently participating, or intends to participate, in another clinical investigation that may confound the results of this study, as determined by Abbott.
3. Subject has or will receive more than one IPG.
4. Subject is pregnant or breastfeeding or plans to become pregnant during the clinical investigation follow-up period.
5. Subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's assessment, could limit the subject's ability to participate in the clinical investigation.
6. Subject has or is scheduled to receive an intrathecal pump.
7. Subject is part of a vulnerable population.
Biomarkers for Human Heart Failure

The purpose of this study is to establish the various ranges of proteins that can be assayed in the plasma and urine from hospitalized patients with all classes of heart failure and/or STEMI (ST-segment elevation myocardial infarction)/NSTEMI (Non-ST-segment elevation myocardial infarction), as well as history reviews.

Schematic Design of the Study: Single blood draw, one random urine and 24-hr urine collection from hospitalized patients with chronic/acute heart failure and/or STEMI-NSTEMI. If there should be a subsequent hospitalization,another collection of a 45 ml blood sample, random urine and one 24-hour urine collection may be completed if indicated at initial hospitalization.

Aims:

The purpose of this study is to attempt to establish the various ranges of proteins that can be assayed from the plasma and urine of patients with all classes of heart failure and MI (myocardial infarction). Follow-up hospitalizations may result in another 45 ml blood draw, random urine and 24-hr. urine collection to evaluate the outcome of the heart failure treatment used with the previous hospitalization, if indicated in consent. A history review will be necessary as well.

Eligibility Criteria:
Inclusion Criteria:

• Diagnosis of Acute decompensated heart failure

Exclusion Criteria:

• Hemoglobin less than 10, active cancer, or amyloidosis Patient with dialysis
Bioavailability of EPA + DHA in a SMEDS Formulation

This study will assess the relative bioavailability of 500 mg eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) in a self-micro-emulsifying delivery system (SMEDS) formulation compared with a standard omega-3-acid ethyl ester product in healthy men and women.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 18.50-29.99 kg/m2
* Good health on basis of medical history and routine laboratory tests
* Score of at least 7 on vein access scale
* Willing and able to remain at site for extended testing periods, including a total of 4 overnight stays, and to consume foods and products provided by study staff on those days
* Willing to abstain from alcohol for 24 h prior to clinic admission
* No plans to change smoking habits or other nicotine use
* Willing to undergo 13 venipunctures during each treatment period

Exclusion Criteria:

* Screening lab test of clinical significance
* Positive urine drug screen
* Clinically significant endocrine, cardiovascular, renal, hepatic, pulmonary, pancreatic, neurologic, gastrointestinal or biliary disorder
* Uncontrolled hypertension
* Recent history or presence of cancer
* Difficulty swallowing capsules
* Recent blood donation or blood loss
* Recent consumption of high-dose fish oil or fish
* Recent use of any prescribed medication or over-the-counter medicinal products, including herbal or dietary supplements (except daily omega-3 fatty acid-free vitamin and/or mineral supplement or occasional use of acetaminophen or non-steroidal anti-inflammatory drugs)
* Signs or symptoms of active infection or has recently taken antibiotics
* Recent history or strong potential for drug or alcohol abuse
* Pregnant, planning to be pregnant during the study, lactating or of childbearing potential and unwilling to commit to use of a medically approved form of contraception throughout the study (note: hormonal contraceptive use is not allowed)
Assessment of Tissue Oxygenation Using Multispectral Imaging

In Canada, the age-standardized prevalence of diabetes is on the rise (increasing from 3.3% in 1998/99 to 5.6% in 2008/2009 Public Health Agency of Canada (July 2011)) and is almost 1 in 10 globally. One of the most devastating complications of diabetes is the loss of a limb, (also known as lower extremity amputation, or LEA) due to complications resulting from a diabetic foot ulcer (DFU). Diabetics have a lifetime risk of 15-25% of developing a DFU1, which can lead to significant decreases in the quality of life, limitations in mobility, function and independence, and increased chance of depression and anxiety. In addition, diabetics post-LEA have high rates of mortality, with 30% dying in the first year post LEA and 70% at 5 years (more than the lifetime risk of dying from cancers). What differentiates a DFU that heals and one that progresses to LEA is often the vascularity of the limb; the diabetic lower extremity often becomes ischemic due to the vascular sequelae that are a common complication of diabetes, which hampers wound closure and immune clearance of wound-associated infections. Understanding limb oxygenation can direct treatment of a DFU, which may require limb revascularization to heal.

The MultIspectral MObile tiSsue Assessment (MIMOSA) Imager acquires digital images to calculate anatomical details of chronic wounds (e.g. diameter, surface area, and perimeter). The device can be worn from a lanyard, and clips onto a smartphone, using natural ambient lighting to capture images of a wound. The MIMOSA also uses up to 6 near-infrared LEDs to illuminate tissue with different wavelengths of light to assess tissue oxygenation.

The Food and Drug Administration (FDA) has previously approved a near-infrared device called the Kent camera for the assessment of tissue oxygenation. The goal of this proposal is to assess tissue oxygenation in a group of healthy volunteers with both the MIMOSA near-infrared imaging device and the Kent Camera.

The investigators hope to show that the MIMOSA Imager is substantially equivalent to the Kent Camera, and as such, the investigators are modeling the investigator's experiments on data previously published by the makers of the Kent Camera. The MIMOSA Imager is a contact-less device, and differs from the Kent Camera only in that it is smaller and more portable.

Eligibility Criteria:
Inclusion Criteria:

Age (years) 26 ± 3 (22-33) Gender (male/female) 6/6 Height (m) 1.70 ± 0.10 (1.56-1.83) Weight (kg) 65 ± 11 (49-79) Body mass index (kg/m2) 22 ± 2 (20-26) Systolic pressure (mmHg) 115 ± 15 (83-138) Diastolic pressure (mmHg) 73 ± 10 (59-91)

Exclusion Criteria:

1. Health concerns including diabetes
2. Patients who are unable to understand the aims of the study and not give informed consent
Interest of Navigation for the Treatment of Pertrochanteric Fractures With the Gamma 3 Nail

The aim of the study is to compare Tip-Apex Distance values in two groups of patients after intramedullary nailing of proximal femur. The first group of patients is operated with the help of a 3D reconstruction device connected to the standard fluoroscopy allowing the surgeon to visualize directly the exact position of the tip of the trans-cervical screw while the second group (which is the reference-group) is operated with the help of fluoroscopy alone.

The main orthopedic complication after fixation of a proximal femoral fracture with a cephalo-medullary nail is the cut-out of the cephalic screw from femoral head resulting in a protrusion of this screw in the coxo-femoral joint, mostly during the first 6 months after the operation. In most cases, the surgeon has to remove the primary implant and perform a total hip arthroplasty to his patient, therefore rising the morbidity and social costs linked to the treatment of the initial fracture.

Baumgartner showed the importance of the position of the cephalic screw for predicting failure of the implant and proposed a new measurement to evaluate this position, the tip-apex distance which is the sum of the distance from the tip of the cephalic screw to the apex of the femoral head on an anteroposterior radiograph and this distance on a lateral radiograph, after controlling for magnification. He showed a lower TAD was associated with a lower risk of cut-out.

The aim of this study is to evaluate the help of a 3D reconstruction software linked to the standard fluoroscopy in achieving the lowest TAD and therefore minimizing the cut-out rate.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a proximal femoral fracture eligible for intramedullary nailing with a Gamma 3 Nail

Exclusion Criteria:

* None