cyrilzakka/clinical-trials huggingface dataset:
Epidemiology of Neurological Complications to Nitrous Oxide Poisoning

N2O inactivates vitamin B12, impairing its ability to act as a cofactor of methionine synthase. In addition, the elimination of vitamin B12 is increased. Neurological damage is similar to that described in combined sclerosis of the marrow, and are probably related to induce vitamin B12 deficiency. The use of N2O can then precipitate the rapid appearance of signs (neurological, psychiatric and hematological) related to a true and/ or functional vitamin B12 deficiency.

In 1978, RB Layzer described the first 3 cases of peripheral neuropathy secondary to nitrous oxide (N2O) consumption. In 2016, a team collected the 91 published cases: among these, 72 had neurological complications, and 52 had a concentration of vitamin B12 considered "low" or "normal-low"

Since then, consumption patterns seem changed due to: an increasing ease of access, the change of container (packaging in cartridge 8 grams versus bottle of 600 grams) and a usually occasional and festive consumption that seems to become solitary and regular, This change in consumption patterns is explained by an increased incidence of neurological complications, although no epidemiological work is yet available.

The objective of this work is to describe the epidemiology of this condition, to correlate it with major recent social phenomena (confinement related to the SARS-Cov2 pandemic), and finally to compare the incidence of myelopathies secondary to N2O with the incidence of other frequent inflammatory neurological diseases (autoimmune myelitis and Guillain-Barré syndrome).


Eligibility Criteria:
Inclusion Criteria:

* Adult patient (≥16 years)
* Hospitalized or having consulted with the departments of Neurology or Internal Medicine for neurological phenomena related to the consumption of N2O. The neurological phenomena included are usually: neuropathies or myelopathies, However, the existence of other neurological or psychiatric signs is not a factor of exclusion: for example, headaches or cognitive or psychiatric disorders with acute onset.
* Exposure to N2O for recreational or medical reasons (Meopa anesthesia).
* Lack of alternative diagnosis other than N2O poisoning
* Consultation for neurological disorders between 01/01/2018 and 31/12/2021

Exclusion Criteria:

* Minor subjects or subjects subject to a legal protection measure (guardianship, curators) during the consultation.
* Refusal to include in a study explained in the file
* Absence of N2O consumption during the 6 months preceding the appearance of signs
A Cost Analysis of Interstim Therapy

A study to examine the impact that Interstim Therapy for Urinary Control has on health care utilization and costs within a health care system and the satisfaction with treatment expressed by patients using this therapy.

A retrospective administrative data analysis combined with a prospective health related quality of life/satisfaction with treatment survey designed to examine the impact that Interstim Therapy for Urinary Control has had on health care utilization and costs for the Kaiser Permanente system and the satisfaction with treatment expressed by patients using this therapy.

Eligibility Criteria:
Patients implanted with an Interstim Therapy for Urinary Control or undergoing test stimulation for potential placement of Interstim Therapy during the period of June 1, 2002 through June 30, 2004 and who are enrolled with Kaiser-Permanente of Southern California.
A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)

The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).


Eligibility Criteria:
Inclusion Criteria:

* Histologic documentation of diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. All participants must have received at least 2 prior lines of therapy
* Participants must have measurable disease as defined by the appropriate disease response criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug
* Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 24 hours before the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study

Exclusion Criteria:

* Known active central nervous system involvement (CNS) or leptomeningeal involvement
* Prior solid-organ transplantation
* Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
* Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade \<= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
* Clinically significant pulmonary compromise defined as the need for supplemental oxygen to maintain adequate oxygenation
* Evidence of clinically significant and/or symptomatic infection (viral, bacterial, or fungal) at the time of study drug initiation. Anti-microbial treatment for infection must be discontinued at least 7 days before the first dose of study drug
Benefits of Choir for Older Adults with Unaddressed Hearing Loss (WP2)

Unaddressed age-related hearing loss is highly prevalent among older adults, typified by negative consequences for speech-in-noise perception and psychosocial wellbeing. There is promising evidence that group singing may enhance speech-in-noise perception and psychosocial wellbeing. However, there is a lack of robust evidence, primarily due to the literature being based on small sample sizes, single site studies, and a lack of randomized controlled trials. Hence, to address these concerns, this SingWell Project study utilizes an appropriate sample size, multisite, randomized controlled trial approach, with a robust preplanned statistical analysis.

The objective of the study is to explore if group singing may improve speech-in-noise perception and psychosocial wellbeing for older adults with unaddressed hearing loss.

The investigators designed an international, multisite, randomized controlled trial to explore the benefits of group singing for adults aged 60 years and older with unaddressed hearing loss. After undergoing an eligibility screening process and completing an information and consent form, the investigators intend to recruit 210 participants that will be randomly assigned to either group singing or an audiobook club (control group) intervention for a training period of 12-weeks. The study has multiple timepoints for testing, that are broadly categorized as macro (i.e., pre- and post-measures across the 12-weeks), or micro timepoints (i.e., pre- and post-measures across a weekly training session). Macro measures include behavioural measures of speech and music perception, and psychosocial questionnaires. Micro measures include psychosocial questionnaires and heart-rate variability.

The investigators hypothesize that group singing may be effective at improving speech perception and psychosocial outcomes for older adults with unaddressed hearing loss-more so than participants in the control group.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 60 years and older;
2. Bilateral mild-to-moderate hearing loss (20-49 dB hearing level), measured using four-frequency pure-tone average across both ears (4FPTA) measured at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz;
3. Unaddressed hearing loss (i.e., participants must not currently use a hearing aid, cochlear implant, or assistive listening device);
4. No significant cognitive impairment, to be assessed with the Montreal Cognitive Assessment for people with hearing impairment (MoCA-H), with participants requiring a score ≥ 24;
5. Not use a pacemaker or anti-arrhythmic agents/medications;
6. Not currently participating in regular active music learning (e.g., choir, formal music training) or audiobook clubs within the last year; and
7. Sufficient language capacity to understand and complete the test materials. Note: all materials will be presented written and/or aurally in English at the sites located in Canada, United States of America, and Australia; Dutch at the Netherlands site; and German at the Germany site.
The Effectiveness of the Use of Oxygen Reserve Index in Preventing Hyperoxia in the Intensive Care Unit.

Oxygen therapy is the most common treatment modality for patients with hypoxemia in intensive care units, but target values for normoxemia are not clearly defined. Therefore, iatrogenic hyperoxemia is a very common situation. In intensive care units, FiO2 is usually adjusted according to hypoxia and hyperoxia is ignored in patients under mechanical ventilator support. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.

Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia. In this study, it was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia in patients undergoing mechanical ventilation in the intensive care unit and to determine the incidence of hyperoxia.

In intensive care units, FiO2 is usually adjusted according to hypoxia and hyperoxia is ignored in patients under mechanical ventilator support. Even though there are many side effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe hyperoxemia frequently.

Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the harmful effects of hyperoxia.

In this study, it was aimed to investigate the effectiveness of ORi-guided FiO2 titration in preventing hyperoxia in patients undergoing mechanical ventilation in the intensive care unit and to determine the incidence of hyperoxia.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years,
* Patients whose oxygen saturation \>97%
* Patients that have invasive arterial monitorization

Exclusion Criteria:

* Patients younger than 18
* Patients that need to be treated with high doses of vasopressors,
* Patients having peripheric hypoperfusion,
* Hemodynamically unstable patients,
* Patients with hemoglobinopathy,
* Pregnancy,
* Morbid obesity (bmi\>40 kg/m2),
* Patients with arrythmia that can result in hemodynamic instability, patients with acute coronary syndrome
* Acute respiratory failure or ARDS.
Use of Percutaneous Tibial Nerve Stimulation With Solifenacin or Placebo to Treat Refractory Overactive Bladder

The null hypothesis for this study is that the combination of solifenacin and Percutaneous Tibial Nerve Stimulation (PTNS) is not different from PTNS alone. However the investigators anticipate a 20% improvement in patients receiving combination therapy as measured by the OAB-q (Overactive Bladder questionnaire) scores.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. history of overactive bladder
3. history of inadequate response to prior or current treatment with anti- muscarinic medication, or unacceptable side effects from higher dose of anti-muscarinic medication
4. PTNS-naive
5. willing to discontinue the use of anti-muscarinic agents for 2 weeks before start of study medication ("washing out")
6. able to swallow and retain oral medication
7. able and willing to participate in the full duration of the study
8. able to read and write (health outcomes questionnaires are self-administered)and understand instructions related to study procedures and give written informed consent
9. OAB-q (items 1-8) score of 30 or higher

Exclusion Criteria:

1. presence of cardiac pacemaker and/or defibrillator
2. history of urinary retention
3. history of gastric retention
4. uncontrolled narrow angle glaucoma
5. any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction,coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 3 months prior to Screening visit
6. abnormal liver function test (greater than 3 times the upper limit of normal for alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], or alkaline phosphatase \[ALP\]); or bilirubin \> 3 times the upper limit of normal
7. history of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject
8. known hypersensitivity to solifenacin
9. participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or any time during the study period
10. pregnancy or trying to become pregnant
11. breast-feeding
Little Lungs Study

This clinical trial is being done to evaluate the clinical response and safety of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.

The main questions it aims to answer are:

* Do the combined drugs improve the respiratory severity score (RSS)
* Is the combination safe

Participants will receive three doses of the study drug.


Eligibility Criteria:
Neonate Inclusion Criteria:

* Gestational age 22 0/7 to 28 6/7 weeks at birth
* Age 7-14 days
* Need invasive mechanical ventilatory support
* Have at least one parent/guardian who is able to provide parental permission in English or Spanish

Birthing Parent Inclusion Criteria:

* Have a baby who meets neonate eligibility criteria and enrolls in the study.
* Is able to provide consent in English or Spanish

Neonate Exclusion Criteria:

* Major congenital anomalies
* History of pulmonary hemorrhage
* Antibiotic use within 48 hours
* Prior treatment with corticosteroids for prevention of lung disease
* Indomethacin or Ibuprofen use within 72 hours
* Have a birth parent aged less than 18 years
* Respiratory severity score less than 2.4
* Not expected to survive for greater than 7 days at enrollment

Birthing Parent Exclusion Criteria:

* Is aged less than 18 years
Follow-up-study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers

Between 2012 and 2014, a cohort of 90 COPD subjects of disease severity grades GOLD I-IV as well as 60 healthy control subjects (30 smokers and 30 non-smokers) have been examined regarding different clinical and blood/ sputum derived biomarkers at the investigators' research center. This observation study will follow-up/re-examine all available subjects regarding disease course and treatment changes after 3 years (+/-6 months) for the investigation of ncRNA/ transcriptome biomarkers for their potential to indicate disease progression. In addition, biobanking of respective biosamples for potential future COPD biomarker research will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Participants in Study "11-03 Ribolution"
* Able and willing to give written informed consent
* Not pregnant, as confirmed by pregnancy test

Exclusion Criteria:

* Past or present disease occurred since participation in "11-03 Ribolution", which as judged by the investigator, may affect the outcome of the study.
* Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety
* Has experienced a significant upper or lower respiratory tract infection incl. moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) within the last 4 weeks. All courses of oral corticosteroids and antibiotics must be completed at least 4 weeks before study start
* Clinically significant pathological findings in safety laboratory tests having an impact on study participation.
* Actual drug or alcohol abuse.
* Suspected inability to understand and follow protocol requirements, instructions, study-related restrictions, and to understand nature, scope, and possible consequences of the study.
* Being a vulnerable subject (dependent, in detention, or without mental capacity)
Free Flap Breast Reconstruction Using Virtual Surgical Planning and 3-D Modeling

The purpose of this study is to determine if 3D modeling and Virtual Planning Surgery can improve the clinical outcome with patient who have a mastectomy requiring breast reconstruction.

Primary objective: Using 3D medical models of the abdomen, a virtual plan will assist reconstruction to clearly define and 3D model the normal and aberrant vascular anatomy of the donor site in order to decrease dissection time and secondary perioperative complications including fat necrosis and donor site complications.

Secondary objective: To propose incision lines to match the corresponding volumetric analysis of the transposed tissue in order to facilitate the creation of a patient specific tailored flap, which will improve the aesthetic outcomes.

This is a single-armed, prospective study to determine the feasibility of using 3-D virtual planning and medical modeling in breast cancer patients undergoing breast reconstruction

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have histologically or cytologically confirmed breast caner undergoing delayed or immediate breast reconstruction.
* Performance statusECOG Performance status ≤ 2
* Subjects must have normal organ and marrow function as defined below:
* Hemoglobin ≥ 10.0 g/dl
* Leukocytes ≥ 3,000/mcL
* Absolute neutrophil count ≥ 1,500/mcL
* Platelet count ≥ 100,000/mcL
* Total bilirubin within normal institutional limits
* AST (SGOT) ≤ 2.5 X institutional upper limit of normal
* ALT (SGPT) ≤ 2.5 X institutional upper limit of normal
* Serum Creatinine within normal institutional limits
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Subjects receiving any prior abdominoplasty or abdominal liposuction, or patient that plan on undergoing radiation therapy after reconstruction.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to IV contrast.
* Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Pregnant or breastfeeding women are excluded from this study because IV contrast and CT scans have the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with breast cancer, breastfeeding should be discontinued.
* Unsuitable donor site volume or vasculature based on pre-operative imaging or physical exam.
Leveraging Home Health Aides to Improve Outcomes in Heart Failure

The purpose of the study is to determine the effectiveness of an intervention among home health aides caring for adults admitted to home care with a primary diagnosis of heart failure at VNS Health Partners in Care (home care agency). The study will examine the interventions' effect on home health aides' heart failure knowledge and confidence caring for adults with heart failure, as well as on the client's overall health (visits to the emergency department and hospital readmissions).

The investigator's central hypothesis is that an intervention that can optimize and improve the experience of home health aides caring for the heart failure patients has the potential to improve home health aides' own self-efficacy, heart failure knowledge, and also patient outcomes. The intervention for home health aides is comprised of a) remote classroom education on heart failure and b) an mHealth app containing HF educational content and a messaging application that connects HHAs and their nurse supervisors. This intervention requires feasibility and acceptability testing, as well as preliminary testing of its effectiveness among home health aides caring for community-dwelling adults with heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Home health aide employed at VNS Health Partners in Care home care agency.
* 1 or more years of experience as a home health aide.
* Speak English or Spanish.
* Assigned to care for an adult admitted to home care with a primary diagnosis of heart failure.

Exclusion Criteria:

* Doesn't meet inclusion criteria.
Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

This multicenter, randomized, open-label study will assess the safety and efficacy of oral treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary fibrosis.

This study will evaluate how oral treprostinil can affect pulmonary vascular resistance, as assessed by right heart catheterization, and exercise capacity, as assessed by the Six-Minute Walk Test. This is a 16-week study that will involve at least 10 clinical trial centers. The expected enrollment period is around 24 months and 52 subjects will be entered into the study.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily gives informed consent
* Must meet criteria for lung transplant referral but is not required to be on an active lung transplant list
* Stable and significant diffuse parenchymal lung disease with a diagnosis of interstitial lung disease
* 6MWD greater than or equal to 75 meters
* Right heart catheterization with a mean pulmonary arterial pressure \>= 30 mgHg, pulmonary capillary wedge pressure \<= 15 mmHg and pulmonary vascular resistance \> 240 dynes
* Echo-Doppler examination showing evidence of right ventricular dysfunction and normal left diastolic ventricular function
* Either not receiving any PAH-approved oral therapy, or is receiving monotherapy (ERA, PDE-5I, or riociguat) for \> 60 days and receiving a stable dose for \> 30 days prior to enrollment
* Able to communicate effectively with study personnel and will to be cooperative with protocol requirements

Exclusion Criteria:

* History of repaired or unrepaired congenital heart disease
* Received prostanoid therapy in the past 30 days, or has shown an intolerance or lack of efficacy to prostanoid therapy resulting in discontinuation or inability to titrate prostacyclins
* Diagnosis of sarcoidosis
* History of thromboembolic disease
* Chronic renal insufficiency
* Pregnancy or lactating
* Currently receiving an investigational drug, has an investigational device in place, or has participated in an investigational drug or device study within 30 days prior to Screening