cyrilzakka/clinical-trials huggingface dataset:
A Study to Determine Safety and Efficacy of (REMD-477) in Controlling Hyperglycemia Due to Copanlisib

REMD-477 (Volagidemab) is a human anti-glucagon receptor antibody. Its proposed mechanism of action in controlling hyperglycemia is by blocking glucagon receptor (GCGR) signaling. In this way, it increases hepatic glucose uptake, decreases hepatic glycogenolysis and gluconeogenesis, increases glycogen synthesis, and ultimately decreases blood glucose levels. This protocol will test the hypotheses that REMD-477 is safe and tolerable in patients with severe hyperglycemia on copanlisib and that it decreases the risk of severe hyperglycemia in patients receiving copanlisib for relapsed refractory lymphoma


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Relapsed or refractory lymphoma (Grade 1, 2, 3A)
* Received 2 or more prior lines of systemic therapy for lymphoma
* Experienced glucose \>250 mg/dL after copanlisib infusion for treatment of lymphoma

Exclusion Criteria:

* Evidence of histologic transformation
* Follicular Lymphoma Grade 3B
* Active CNS involvement by malignancy
* Elevated AST or ALT \> 5x ULN at Screening
* Unmanageable sensitivity to mammalian-derived drug preparations, or to humanized or human antibodies; managed sensitivities to agents such as obinutuzumab or rituximab or similar agents are not exclusionary
* History of drug or alcohol abuse within the last 6 months
* History or family history of pancreatic neuroendocrine tumors or multiple endocrine neoplasia
* History or family history of pheochromocytoma
* Other gastrointestinal, cardiac, renal and CNS (i.e. hypoglycemia unawareness) conditions specific to diabetes that would pose additional risk to subject's safety or interfere with the study evaluation, procedures or completion in the opinion of the treating physician.
* Female subject is pregnant or breastfeeding.
Assessment of Safety & Efficacy of Light Weight Breast Implant

The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast Implant (LWBI) in breast augmentation.

This is a Single-center. The purpose of the study is to evaluate safety and effectiveness of LWBI in breast augmentation.

Eligibility Criteria:
Inclusion Criteria:

* Genetic women at ages 18 to 65 seeking breast enlargement
* Signed informed consent
* Agreement to complete all required follow up visits
* A medically acceptable candidate
* Sufficient breast tissue for proper implant coverage (≥20 mm by pinch test)

Exclusion Criteria:

* Patients with active infection anywhere in their body
* Women who are currently pregnant or nursing
* Insufficient tissue covering in the prospective area of implantation (e.g. after preceding breast reduction), radiation damage or reduced vascularization
* Abscesses, malignant tumors(cancer or recurrent metastases), advanced fibrocystic diseases
* Patients with a history of psychiatric treatment
* Patients that been implanted with any silicone implant (e.g. silicone artificial joints, facial implants)
* Expected allergies or extraordinary immune response to implants
* Wound healing impairments or heavy burn scars
* Existing costal injuries
* The Patient Participated in an investigational trial within 30 days of enrollment
Peripheral Neuropathy in Patients Receiving Enfortumab Vedotin and Pembrolizumab As First Line Treatment for Metastatic or Locally Advanced Urothelial Carcinoma

The P-EVOLUTION trial is a prospective, multicenter, non-interventional observational study aimed at investigating peripheral neuropathy in patients receiving first-line treatment for metastatic or locally advanced urothelial carcinoma with enfortumab vedotin (EV) and pembrolizumab (P). Conducted at two German university hospitals, the study will track the incidence and severity of peripheral neuropathy, its impact on quality of life, and treatment regimen adjustments due to side effects. Approximately 80 patients are expected to be enrolled over one year.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, ≥18 years of age at the time of signing the informed consent form (ICF)
* Patients with histologically confirmed metastatic or locally advanced, unresectable urothelial carcinoma
* Patients who did not receive any systemic treatment for their laUC or mUC (treatment-naïve)
* Patients who are able to receive enfortumab vedotin and pembrolizumab according to the respective medicinal product information

Exclusion Criteria:

* Patients with contraindications for enfortumab vedotin and/or pembrolizumab
* Patients who have received a systemic therapy for their laUC or mUC (e.g. platinum-based chemotherapy, checkpoint-inhibitors)
* Patients who have previously been treated with enfortumab vedotin, other MMAE-based antibody-drug-conjugates or PD-(L)1-checkpoint inhibitors
* Patients who received neoadjuvant or adjuvant platinum-based chemotherapy \<12 months ago
Comparing Portal Vein Assessment by Intraoperative Doppler and Transesophageal Echocardiography

Liver transplantation is usually associated with hemodynamic instability. TEE allows for a real time monitoring of cardiac structures and has become a standard of care for liver transplant patients. Society of cardiovascular anaesthesia and American society of anaesthesiologists recommends use of TEE in non-cardiac surgery patients with hemodynamic instability. Also, society for advancement of transplant anaesthesia (SATA) has suggested that TEE usage in cases of liver transplant is safe, effective and improves outcomes. TEE can also provide vital information relating to non-cardiac structures including liver, spleen, kidneys, portal vein, hepatic vein and other major vessels. As of now standard protocol is to do the transabdominal doppler for the assessment of portal vein after the liver graft implantation. Hence, the aim of our study is to compare the transesophageal echocardiography and transabdominal Doppler for assessing portal vein in living donor liver transplantation.

Data from all patients who underwent live donor liver transplant surgery at Institute of Liver and Biliary Sciences, New Delhi and in whom TEE probe was inserted will be collected and analysed.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have undergone Live donor liver transplant, Age \> 18 years

Exclusion Criteria:

* Required data is not available
Single-probe Microwave Ablation (MWA) of Metastatic Liver Cancer

Microwave ablation (MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate the variability and reproducibility of single-probe MWA versus radiofrequency ablation (RFA) of metastatic liver tumours smaller than 3 cm in patients without underlying liver disease.


Eligibility Criteria:
Inclusion Criteria:

* Unresectable metastatic liver cancer
* No invasion of major biliary structures
* No invasion of major vascular structures
* ASA score \< 4
* WHO score 0-1
* Pre-operative chemotherapy is allowed

Exclusion Criteria:

* Resectable liver metastases
* Life expectancy less than 3 months
* Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials
* Coagulopathy with platelet count less than 50000
* Active infectious disease
* Age below 18 years
* Pregnancy of breastfeeding
Triathlon PSR Outcomes Study

This study is a prospective, open-label, post-market, non-randomized, multi-center clinical evaluation of the Triathlon Total Knee System using the Triathlon PSR Tibial Insert for primary total knee arthroplasty (TKA) in a consecutive series of patients who meet the eligibility criteria. The SF-36 score of subjects receiving the Triathlon Total Knee with the Triathlon PSR insert is expected to be comparable with that of subjects receiving historical Triathlon PS cemented constructs.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has signed an IRB/EC approved; study specific Informed Patient Consent Form.
2. Patient is a male or non-pregnant female, skeletally mature, age 18-75 years at time of study device implantation.
3. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
4. Patient is a candidate for primary cemented total knee replacement.
5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Patient has a Body Mass Index (BMI) \> 45.
2. Patient is already participating in the study for a contralateral total knee replacement.
3. Patient has a diagnosis of avascular necrosis or inflammatory arthritis.
4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
5. Patient has any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
6. Patient has a compromised bone stock which cannot provide adequate support to the prosthesis.
7. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
8. Patient is diagnosed with lumbar radicular pain.
9. Patient has severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
10. Patient has a known sensitivity to device materials.
11. Patient is a prisoner.
A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects

The purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with ivacaftor on lung function.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects must be between the ages of 18 and 55 years, inclusive
* Body mass index (BMI) of 18 to 31 kg/m2, inclusive, and a total body weight \>50 kg.

Exclusion Criteria:

* History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject. This may include, but is not limited to, a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; or history of mental disease.
* History of febrile illness within 5 days before the first dose.
* History of Gilbert's syndrome
* Abnormal renal function as defined at screening
* Blood donation of approximately 1 pint (500 mL) within 56 days before study drug administration
* Treatment with an investigational drug within 30 days or 5 half-lives (or as determined by the local requirements, whichever is longer) preceding the first dose of study drug
* Known hypersensitivity or prior adverse reaction to ciprofloxacin, or any member of the quinolone class of antimicrobial agents (Cohort 1 only); itraconazole, or to any of the other azoles (Cohort 2 only); rifampin, or to any of the rifamycins (Cohort 3 only)
Role of Platelet Rich Plasma in Bone Regeneration After Enucleation of Odontogenic Jaw Cysts

in the present study, the effect of PRP on bone regeneration when applied to the site of removal of cyst of the jaws is evaluated. PRP was delivered to the site combined with gelfoam. Thrombin clot accelerator was not used.

Jaw cysts are common lesions in the oral and maxillofacial region. Enucleation of cyst wall \& curettage has evolved as the treatment of choice. In order to reduce infections and to accelerate bone regeneration, by using of Platelet rich plasma.

Platelets are involved in regeneration at sites of pathology, apart from their role in clotting. A preparation composed mainly of platelets (platelet-rich plasma gel) applied to sites of bony pathology, after surgical treatment of lesions, may hasten bone regeneration.

An interesting idea developed that the addition of a concentrate of platelets, to wounded tissues or surgical sites, may enhance the body's natural wound healing mechanisms . Platelet-rich plasma (PRP) is the accepted term to describe the preparation made out of autologous platelets suspended in autologous plasma, in concentration greater than normally found in peripheral blood Because it is autologous, PRP avoids the risk of transmissible diseases such as HIV, Hepatitis B, C or D and other blood-borne pathogens .A clot accelerator such as bovine thrombin is added to gel the PRP or PRP is added to other materials such as collagen, gelfoam, etc.

Eligibility Criteria:
Inclusion Criteria:

1. Size of the cyst more than 2 cm
2. The lesion could be visualized radiographically
3. Patients within the age range of 20 to 50 years

Exclusion Criteria:

1. Patients who were alcoholics \& smokers
2. -Patients with systemic diseases
3. History of bleeding tendencies, blood dyscrasia
4. Low platelet count
5. Patients unable or unwilling to return for follow-up
Teriflunomide Tecfidera LMCE

This study will investigate the effect of teriflunomide in reducing cortical gray matter (CGM) atrophy and leptomeningeal (LM) inflammation over 24 months compared to dimethyl fumarate (Tecfidera®)


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MS according to McDonald criteria
* Age 18-65 years
* Relapsing disease course
* Expanded Disability Status Scale (EDSS) score of ≤ 5.5
* MRI obtained at baseline (medication start date), 12 months, and 24 months
* Treated with 14mg of teriflunomide ≥ 3 months or with 240mg of dimethyl fumarate ≥ 3 months to meet inclusion, reflective of recommended dosing on the package label
* Clinical information available over the 24 month follow-up
* None of the exclusion criteria

Exclusion Criteria:

* Diagnosis of non-relapsing MS
* Use of experimental drug or investigational procedure during the study period
* Pregnancy during study period
* Severe hepatic impairment
* Relapse within 30 days prior to any of the 3 MRIs
* Corticosteroid use within 30 days prior to the MRIs
* Teriflunomide patients who have used leflunomide
* Pre-baseline use of alemtuzumab, cladribine, rituximab, or mitoxantrone
* Any other factor that, in the opinion of the investigator, would make the subject unsuitable for participation
High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery

This is a feasibility study to determine if enough patients undergoing elective or urgent cardiac surgery, can be enrolled in a study where patients are randomized to receive high spinal anesthesia as an adjunct to general anesthesia for their cardiac surgery. The primary clinical outcome will be the incidence of post-operative delirium.

Intervention

Patients will be randomized to either general anesthesia (GA) or HSA + GA.

1. Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg).
2. Standard intraoperative monitors will include ECG, pulse oximetry, end-tidal CO2 and anesthetic gas measurement, quantitative EEG monitoring (BIS monitor), arterial line, central venous pressure line and any other monitor as clinically indicated.
3. Conduct of the general anesthetic will not be protocolized. It will be a pragmatic study. The attending anesthesiologist will attempt to have a BIS score of 20- 40 during the operation.
4. Intraoperative physiological data (mean blood pressure, end-tidal anesthetic gas concentrations, BIS score) will be recorded and downloaded to a laptop computer using the Trend Face Solo acquisition system for subsequent analysis.
5. The routine postoperative care map for the postoperative cardiac intensive care unit (ICCS) will be followed.
6. All patients will be assessed by the study investigator for presence/absence of delirium on postoperative days 1,2 \& 3, as well as routine nursing assessment by the delirium assessment tool CAM-ICU, routinely done by nursing staff. Chart reviews will be conducted to confirm any additional incidence of delirium.
7. All patients will be contacted at one and three months after surgery and asked to complete a ten-minute survey (Postop QoR-15 questionnaire) assessing their quality of recovery.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\>18 years old) patients
* Undergoing elective or urgent cardiac surgical procedures with cardiopulmonary bypass

Exclusion Criteria:

* Contraindications to spinal anesthesia such as active anticoagulation, clopidogrel within 7 days of surgery, ticagrelor within 3 days of surgery and all other contraindications to lumbar puncture
* Pre-existing psychiatric diagnoses such as schizophrenia or manic-depressive disorder
* Complex aortic surgery (\> hemi-arch repair, descending thoracic surgery)
* Difficult airway requiring an awake intubation
* BMI \> 50
Efficacy Study of Auriclosene Irrigation Solution on Urinary Catheter Patency

Long-term indwelling urinary catheters are associated with chronic recurrent urinary tract infections and blockage caused by crystalline biofilm accumulation (encrustation) of the catheter surfaces. When the urine and catheter are colonized by urease-producing bacteria such as Proteus mirabilis, encrustation of the catheter is likely to occur.

The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs and better patient quality of life.

Auriclosene is a non-antibiotic, fast-acting, broad-spectrum antimicrobial, which exhibits potential for the rapid decolonization of a range of urologic pathogens, including the urease-producing Proteus mirabilis.

Subjects will be randomized to either Auriclosene Irrigation Solution or Auriclosene Vehicle solution.


Eligibility Criteria:
Inclusion Criteria:

* Subject requiring an indwelling urinary catheter with a history of catheter blockage and/or encrustation
* Screening within 30 days of randomization

Exclusion Criteria:

* Systemic antibiotic use within 14 days of first treatment
* Investigational drug or device within 30 days if enrollment
* Current infection requiring treatment with systemic antibiotics
* Pregnant or lactating female
Interest of the Dosage of Ferritin / Glycosylated Ferritin in COVID-19

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a new coronavirus responsible for the pandemic called coronavirus disease 2019 (COVID-19), which appeared in China in December 2019 and which has spread rapidly around the world. Even if in the vast majority of viral infection results in a mild illness, it can also progress to a severe form with sometimes fatal consequences.

Indeed, clinical worsening, between the 7th and 10th days of the onset of symptoms, has been widely described since the start of the pandemic. This manifests itself at the biological level by hyperinflammation (VS, CRP, ferritin), coagulopathy (elevation of D-dimers, sometimes disseminated intravascular coagulation) and cell lysis (CPK, LDH).

At the same time, it was observed high levels of pro-inflammatory cytokines (IL-1β, IL-6, TNF-α, IL-18), suggestive of a cytokine storm, and the first studies on therapeutic management targeting these cytokines are currently underway in COVID-19.

Such a profile strongly recalls on the one hand the cytokine release syndrome (CRS, observed in CAR-T cell therapy in malignant hematology), and on the other hand the lymphohistiocytic activation syndrome (SALH). Systemic diseases, such as adult Still's disease and its pediatric side, can also be complicated by a cytokine storm, known as macrophagic activation syndrome (SAM, equivalent to secondary SALH). Under all these conditions, IL-1β, IL-18, IFN-γ and IL-6 seem to be key mediators of hyperinflammation.

Plasma ferritin is a biological marker of inflammation, long known, associated with various infectious, hematological and immunological conditions. An increase in ferritin levels has in particular been associated with an unfavorable development in certain infections such as influenza and certain authors have moreover shown an association between plasma ferritin and the evolution towards ARDS or death in patients. Its dosage is also used as a diagnostic tool for SAM, and could make it possible to differentiate the latter from severe sepsis in intensive care. Some authors have also noted it as a prognostic factor in Kawasaki disease or CRS.

The plasma dosage of ferritin, associated with that of its glycosylated fraction, could therefore be a diagnostic (difference between SAM and severe sepsis in intensive care), prognostic (evolution towards ARDS, mutation in intensive care, mortality) and therapeutic (indication of preemptive treatment with an inhibitor of IL-1 or IL6) in patients infected with SARS-CoV-2.

The objective of this study is to retrospectively assess the prognostic value of ferritin and glycosylated ferritin in SARS-CoV-2 infection in hospitalized.


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in the internal medicine department of the Croix-Rousse hospital and positive for the SARS-COV 2 (nasopharyngeal sample, the test was appoved by the French national medical authorities).

Exclusion Criteria:

* Not applicable
Medico-economic Evaluation of a Non-chirurgical Pulmonary Valve Replacement (REVALV)

This prospective interventional study is designed to evaluate the cost/advantage ratio in the treatment of lesions of the right ventricular outflow tract using transcatheter pulmonary valved stent (Melody).

Rational : transcatheter valve insertion is a new technique enlarging the armamentarium of the treatment of RVOT obstruction and insufficiency. It real place as compared to bare stent implantation and surgery of the RVOT remains unknown.

Main objective : evaluate the cost of the procedure as compared with conventional technique.

Design : multicenter intervention prospective study. Population : 180 patients in three arms (3\*60).

End point criteria :

* Primary : cost
* Secondary : rate of reoperation

Eligibility Criteria:
Inclusion Criteria:

for the study:

* Lesions of the right ventricular outflow tract in need of surgery for stenosis or regurgitation

for the Melody arm:

* A 5 to 70 years old patient
* Weight \>= 30kg
* RVOT \<= to 22mm
* Patient with a dysfunction circumferential prosthetic conduct of diameter \>= to 16mm.

Exclusion Criteria:

* Vein anatomy incompatibility with a 22Fr delivery health
* Left heart implantation
* RVOT incompatible with a anchoring of the stent (lik in patient operated of a tetralogy of fallot)
* Coronary anomaly with a coronary artery naer the RVOT
* Sever obstruction of the RVOT incompatible with balloon expansion
* Central vein obstruction
* Ongoing infection
* Active endocarditis
* Allergy for heparin or aspirin
* Pregnancy
Subject Satisfaction With AbobutulinumtoxinA Treatment

An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.

Following signature of informed consent and the screening process, eligible subjects were treated at the Baseline visit (Day 0) with abobotulinumtoxinA in the glabellar region. Subjects were re-treated at the Month 6 visit.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to Severe Glabellar Lines at Maximum Frown
* Understands study requirements and signs an informed consent

Exclusion Criteria:

* Known allergy to any component of study product
* Pregnant or breast feeding or intending to get pregnant during the study
* Botulinum toxin treatment in the face within 9 months