cyrilzakka/clinical-trials huggingface dataset:
Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study

This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. The procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else.

Safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (CT) images before and after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Individuals presenting with at least one kidney stone apparent on CT.
* Stones must be within the upper urinary tract.
* Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8
* Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones).

Exclusion Criteria:

* Acute untreated urinary tract infection or urosepsis.
* Uncorrected bleeding disorders or coagulopathies.
* Pregnancy.
* Uncorrected obstruction distal to the stone.
* Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure.
* Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus.
* Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.).
* Patients unwilling to comply with the follow-up protocol, including post-procedure CT.
* Individuals under 18 years of age.
* Anatomic presentations preventing adequate positioning or delivery of the Break Wave pulse.
* Calcified abdominal aortic aneurysms or calcified renal artery aneurysms.
* Solitary kidney
* Comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
Efficacy of Nasal Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal

The common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. At the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment.

The study has parallel distribution design, with two equal groups, in which one group will be treated by a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.

STUDY DESIGN

* randomized,double blind, prospective, multicentric, parallel group, intent to treat trial
* Experiment duration: 3 days
* 2 visits (days 0 and 2)
* Evaluation of symptoms reduction
* Adverse events evaluation

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be able to understand the study procedures, agree to participate and give written consent.
2. Patients aged over 18 years of both sexes;
3. Patients with clinical signs of flu and colds or other upper respiratory allergies;
4. Patients with early signs and symptoms with time of evolution not more than 72 hours.

Exclusion Criteria:

1. Patients treated with antibiotics
2. Current treatment with immunosuppressants (eg.cyclosporine or methotrexate);
3. Use of intranasal cromalin the week before inclusion;
4. Use of decongestants or anti-histaminic (intranasal or systemic);
5. Presence of any disease or anatomical abnormality that may difficult the data analysis ;
6. Uncontrolled hypertension;
7. Presence of respiratory symptoms for more than 14 days;
8. History of abuse of drugs and alcohol;
9. Presence of other concomitant pulmonary diseases;
10. Hypersensitivity to any compound of investigational product
Evaluating Evidenced Based Options for PTSD Treatment

This study will look at:

How practical it is to offer another round of proven therapy. How effective different therapy options are for people who didn't respond to the first treatment.

The goal is to improve personalized care by:

Identifying factors that might predict how someone will respond to a second treatment.

Creating a simple tool to spot people who might not respond to treatment early, so they can start a different option sooner.

The findings will help improve PTSD care by offering better follow-up treatments and matching patients with the approach that works best for them.


Eligibility Criteria:
Inclusion Criteria:

* Are 18 years or older
* Are fluent in English
* Have experienced a Criterion A traumatic event during their lifetime
* Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5
* Are interested in receiving evidence-based treatment for PTSD and able to attend 10 therapy sessions over the course of 2 weeks (10 days) and could possibly attend another 10 sessions of a subsequent treatment (additional CPT sessions, PE, or STAIR)
* Are willing and able to complete self-report measures and clinician-rated assessments at multiple timepoints over the course of the study

Exclusion Criteria:

* The index traumatic event occurred in the past month
* They are currently suicidal or homicidal (i.e., current plan and imminent intent)
* They have unmanaged psychosis or mania
* They have not been on a stable dose of psychotropic medication for at least one month at the time of the baseline assessment
* They have completed an evidence-based cognitive behavioral PTSD treatment in the past three months or are currently engaged in an evidence-based PTSD treatment (CPT, PE)
* They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in treatment
* They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year
* They have an active substance use disorder (within the past three months) that would require immediate medical observation if substance was abruptly discontinued
* They are involved with current legal actions related to their index trauma
* They have a visual or auditory impairment that would prevent them from fully participating in study activities
* They, at the time of consent, appear to have extenuating life circumstances (i.e., unstable housing, no internet access, etc.) which, in the judgement of the study team, could affect the ability to deliver interventions with fidelity
Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®

The purposes of this study are assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months of age when medications to prevent fever are given on the same day as the vaccination. Also to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who receive medications to prevent fever on the day of vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Aged 2 months (56 to 98 days) at time of enrollment.
* Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

* Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib conjugate vaccines.
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Allergy or contraindication to paracetamol or ibuprofen administration.
* Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio, Hib, or HBV vaccines.
Endothelial Dysfunction and Non-cardiac Surgery

Endothelial dysfunction is a cardiovascular disease hallmark. After non-cardiac surgery, cardiovascular events correlate with surgical outcomes. Understanding the role of endothelial function in these events is crucial.

This research aims to study endothelial function and its association with cardiovascular events.

To study the presence of endothelial damage and its association with cardiac events, the investigators will perform an observational study to evaluate flow-induced dilatation of the brachial artery in patients scheduled for non-cardiac surgery.

After ethical review board approval, the investigators will select 200 patients admitted for non-cardiac surgery. After the patient written consent, the investigators will perform an ultrasound evaluation of the brachial artery flow-mediated dilatation. This will be performed before, during, and after surgery. A basal troponin level will be obtained and repeatedly measured in the three days after surgery.

The investigators will observe clinical outcomes one, 3, and 6 months after the hospitalization.

To observe 8% of events, for a 5% alpha and 80% power, 161 patients are needed for our study. The authors considered that to account for a loss of 10% of patients, a sample of 177 patients will be required. Considering no national or local incidence of cardiovascular events, we aim to complete a 200-patient selection.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patients 45 years or older

Exclusion Criteria:

* Refuse to participate in the study
* Myocardial injury or acute myocardial infarction less than two weeks ago
* Patients who expect less than 2 days of hospitalization
* Patients in whom the troponin elevation is attributed to a secondary cause (for example, sepsis, pulmonary thromboembolism, electrical cardioversion, etc.)
* Use of chemotherapy less than 2 weeks ago
Exploratory Study of ART-123 for the Prevention of Cancer Treatment Related Symptoms in Patients With Postoperative Stage II / III Colon Cancer

The purpose of this study is to evaluate the efficacy and safety of ART-123 for the prevention of cancer treatment related symptoms in patients with postoperative stage II / III colon cancer.


Eligibility Criteria:
Main Inclusion Criteria:

* Diagnosed with stage II / III colon cancer
* Deemed to have undergone curative A (Cur A) surgery
* Planning to undergo postoperative adjuvant chemotherapy

Main Exclusion Criteria:

* Have a history of hypersensitivity to any of the ingredients in thrombomodulin alfa (recombinant)
* Have any treatment history of systemic chemotherapy (including any drug in the clinical trial stage) or radiotherapy
* With active double cancer
Dexmedetomidine Infusion Effect on Hemodynamic Variables During Craniotomy

There is no clear consensus among neuroanesthesiologists regarding which anesthetic regimen is optimal for craniotomy. Propofol and short-acting opioids (such as remifentanil, fentanyl, or sufentanil) are commonly used. However, use of opioids is associated with increased risk of respiratory depression and postoperative nausea and vomiting. Dexmedetomidine is a highly selective α2-adrenoreceptor agonist that has been considered as a useful and safe adjunct to anesthesia for various surgical procedures

The investigators designed this randomized, double-blind study to evaluate the effectiveness of administration of Dexmedetomidine infusion at a dose of 0.5 µg/kg/h without loading dose during elective supratentorial craniotomy under GA. The investigators will compare intraoperative hemodynamics in both groups, intraoperative analgesic consumption, intraoperative blood loss, postoperative sedation scores, intraoperative need for rescue hypotensive agents, and finally the satisfaction of surgeons.

To our knowledge, the present study is the first to evaluate the effect of Dexmedetomidine infusion without loading dose in elective supratentorial craniotomy

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesiologists- Physical status (ASA-PS) I and II patients,
* aged 18 to 65 years
* 70-80 kg
* both sexes
* undergoing elective supratentorial craniotomy for tumor resection

Exclusion Criteria:

* Patients under 18 years of age
* pregnancy,
* emergency surgery
* patients with a Glasgow Coma Score (GCS) less than 15.
* Those who had respiratory or cardiac dysfunction, renal insufficiency, liver impairment, or bleeding disorders
Local Compression Seroma DIminution Objective (CLODIS)

This study evaluates the impact of local compression by chest bandage on the number of seroma punctures in patients treated by mastectomy with or without lymphadectomy. Half of the participants will have local compression by chest bandage in addition to seroma punctures while the other half will only have punctures.

The most common complication induced by mastectomy is seroma formation. This seroma is a serolymphatic effusion that is created in the days following surgery. Iterative puncture is the only treatment for seroma mentioned in the literature. A retrospective study in the investigator's establishment on 1800 patients determined that a second puncture greater than 250ml is predictive of a chronicisation of punctures. The research hypothesis is that by applying local compression by chest bandaging with the Urgo® K2 kit, the "dead space" created by surgery would be removed. This would help resorb the seroma and reduce the number of punctures.

Eligibility Criteria:
Inclusion Criteria:

* Patient followed for histologically proven breast cancer treated by total mastectomy, whether or not dissociated from the sentinel node technique, with or without axillary curing.
* Patient with a second seroma puncture with a volume greater than or equal to 250 ml.
* Neo adjuvant chemotherapy authorized.
* Absence of known metastases.
* Patient has given written consent.

Exclusion Criteria:

* Mastectomy with immediate reconstruction.
* Partial mastectomy.
* Concurrent bilateral mastectomy.
* Delay in healing observed at inclusion.
* Patient under legal protection.
* Chronic respiratory failure.
* Patient with a pacemaker.
* Personality disorders and known progressive psychiatric pathology.
* Inability to submit to trial follow-up
Cultures a.m.Kamme-Lindbergh in Suspicion of Infected TKA

Cultures from total knee arthroplasties, obtained a.m. Kamme-Lindberg in revision cases.


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:
Genomic Study of Congenital Malformation

Genomic aberrations in patients diagnosed as congenital malformation with unknown etiology will be identified using high-density oligonucleotide array.

The Affymetrix GeneChip® Human Mapping SNP 6.0 array, includes more than 900,000 SNP probes plus more than 900,000 CNV probes in a single chip, can provide high density makers information for the human genome. The median inter-marker distance is 670 bases and the average inter-marker distance is 1.67 kb, and the resolution can be as high as 200 kb. The Affymetrix® Cytogenetics Whole-Genome 2.7M Array gives the greatest power to detect known and novel chromosome aberrations across the entire genome. In addition, the whole-genome array includes 400,000 single nucleotide polymorphisms (SNPs) to enable the detection of loss of heterozygosity (LOH), uniparental disomy (UPD), and regions identical-by-descent.

If we are able to identify the candidate genomic regions that are associated with the congenital malformation/syndrome, we may have a better chance to understand the pathogenesis of congenital malformation/syndrome as well as the mechanisms underlying the abnormal chromosome rare diseases. The results from this study can also facilitate the clinical diagnosis and provide genetic basis for consultation.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is diagnosed as congenital malformation/syndromes.
2. Participants can be any ages, and both males and females are eligible.
3. Subjects agree and are capable of giving informed consent. If participants are under 18 years old or incapable of giving consent, an informed consent must be approved by their legal guardians.
4. Availability and willingness of the proband and first-degree biological family (parents, full sibling, or adult-age offspring) who also meets the same congenital malformation syndrome.
5. Availability and willingness of the proband's biological parents whatever with or without the same congenital malformation syndrome.

Exclusion Criteria:

1. Subject or legal guardian is unable to understand or give informed consent.
2. The molecular cause for congenital malformation/syndromes of subjects or their affected first-degree biological family (parents, full sibling, or adult-age offspring) can be revealed by karyotype assay or FISH.
Efficacy and Safety of Imatinib and Vinorelbine in Patients With Advanced Breast Cancer

This study is designed to investigate the safety and efficacy of the combination of imatinib and vinorelbine in patients with advanced, anthracycline resistant breast cancer


Eligibility Criteria:
Inclusion criteria:

* Histologically documented diagnosis of invasive breast cancer that is locally advanced or metastatic
* Previous anthracycline containing chemotherapy
* Presence of a certain protein on the cell surface (c-kit (CD117) and /or PDGF-receptor)
* Preferably tumor samples should be taken within 6 weeks of study entry. Most recent primary tumor tissue has to be available for analysis
* Acceptable health status (Eastern Cooperative Oncology Group \[ECOG\]-performance status 0,1, 2 or 3)

Exclusion criteria: (for the second-line therapy)

* Patient with Grade III/IV cardiac problems (i.e., congestive heart failure, myocardial infarction within 6 months of study) and with severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
* Patient has a known brain metastasis, chronic liver disease (i.e., chronic active hepatitis, and cirrhosis) and diagnosis of (HIV) infection.
* Patient received chemotherapy within 4 weeks prior to study entry, unless the disease is rapidly progressing.
* Patient previously received radiotherapy to ≥ 25 % of the bone marrow and had a major surgery within 2 weeks prior to study entry.
* Patient received either Vinorelbine or Imatinib in previous treatment regimens

Other protocol-defined inclusion/exclusion criteria may apply
Comparison of the Natural Frequencies Technology Sleep Patches to Sham Patches During Sleep in the Home Environment

Prospective, randomized crossover study to compare the NFT sleep patches to sham device to assess sleep via home sleep testing device in the home environment


Eligibility Criteria:
Inclusion Criteria:

* capacity to provide informed consent
* BMI \<30
* between 30 and 65 years old
* in overall good health as determined by history and physical assessment subjects pre-screened to ensure they are drug free
* work a typical day job/work week.
* not traveled \> 3 time zones in the last month
* typical bedtime between 9-12 PM
* estimated on average 6 hours per night
* negative urine drug screen
* have self-reported unrefreshing sleep for the past month
* agree to limit alcohol use to no more than two drinks a night during the testing period and four hours prior to bedtime
* agree to limit caffeine consumption to four hours prior to bedtime
* ≤ 2 on the depression scale
* ≤ 3 on the anxiety scale

Exclusion Criteria:

* pregnant or nursing a child
* self-induced short sleep habits (\<6 hours per night)
* unstable medical conditions as determined by the clinician
* current sleep disorder (sleep apnea AHI/REI\<5, restless legs, periodic limb movements, narcolepsy)
* self-reported sleep latency of \>30 minutes or early (3-4 AM) awakenings on a regular basis
* contact dermatitis to adhesives
* excluded Medications: over the counter sleep aids, prescribed sleep aids, central nervous system stimulants, antidepressants, sedating antihistamines, over the counter decongestants and opioids
An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy

This is a multicenter, open-label extension of the clinical study NLS-1021, evaluating long-term safety, tolerability, pharmacokinetics (PK), and therapeutic response to treatment with NLS-2 in adult subjects with narcolepsy.


Eligibility Criteria:
Inclusion Criteria:

* The subject must complete all Study NLS-1021 study requirements and assessments up to Visit 6;
* The subject is able, in the opinion of the Investigator, to receive NLS-2 for the 24-week Treatment Phase of this study;
* Biological females of childbearing potential must agree to use a medically acceptable double-barrier method of contraception for at least 30 days prior to Day 1 and until completion of the study;
* The subject is able to comply with the open-labelled extension design schedule and other study requirements;
* The subject provides written informed consent for the open-label extension study.

Exclusion Criteria:

* The subject meets any Exclusion Criteria for Study NLS-1021 at Visit 6 of that study;
* The subject receives any investigational drug (other than the COVID-19 vaccine) that is not NLS-2.
Intravitreal Ranibizumab to Treat Macular Edema After Panretinal Photocoagulation (Phase II)

This is a randomized, open-label Phase II study evaluating the safety and efficacy of intravitreally administered ranibizumab 0.5mg in subjects with Proliferative Diabetic Retinopathy experiencing post- Panretinal Photocoagulation (PRP) macular edema.

Levels of VEGF are elevated in eyes wth Diabetic Macular Edema and the expression of VEGF was found to be elevated temporarily following the photocoagulation of human Retinal Pigment Epithelial (RPE) cells. Ranibizumab (Lucentis TM, Genentech) is an anti-VEGF antibody shown to have properties to prevent macular edema. We hypothesize that VEGF inhibition can effectively treat PRP-induced macular edema, thereby minimizing post-PRP vision loss.

Subjects who meet eligibility criteria will receive 0.5mg ranibizumab administered 7-14 days post-PRP. Additional intravitreal injections of 0.5 mg of ranibizumab at Day 30 and/or Day 60 may be also be administered. All subjects will be followed for 90 days for safety and efficacy assessments. There is no placebo or sham arm of this trial.

Eligibility Criteria:
Inclusion Criteria:

* Pre-PRP protocol refraction, fluorescein angiography, and optical coherence tomography AND 7-14 day post-PRP OCT
* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age 21 years or older
* Previously untreated PDR patients with high risk characteristics who develop edema within 7-14 days post PRP therapy. This edema, determined by a masked investigator, will be characterized as either increased foveal thickness (\>10% increase from pre-PRP foveal thickness), and/or increased macular volume on OCT (\>10% increase from pre-PRP macular volume).

Exclusion Criteria:

* Pregnancy (positive pregnancy test) prior to enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
* Participation in another simultaneous medical investigation or trial
* Pre-PRP clinically significant diabetic macular edema (CSME) that would make the patient eligible for macular laser prior to PRP
* Neovascularization of the iris or neovascular glaucoma
* Increased central foveal thickness for any other reason
* Concurrent macular diseases that could confound the results of this study
* Prior vitrectomy in the study eye
* Prior treatment with intravitreal injection including pegaptanib sodium, ranibizumab, bevacizumab or triamcinolone acetonide