cyrilzakka/clinical-trials huggingface dataset:
Pharmacodynamics Assessment Study After Single Subcutaneous Dose Of SAR113244 Versus Placebo In Lupus Male And Female Patients

Primary Objective:

Assess in systemic lupus erythematosus (SLE) patients the effect of SAR113244 on B-cell subsets compared to placebo.

Secondary Objectives:

Assess in male and female lupus patients after SC single dose of SAR113244 the tolerability and safety of SAR113244.

Assess in male and female lupus patients:

* The pharmacokinetics of SAR113244.
* The pharmacodynamics of SAR113244 for the following disease parameters:

  * Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) score, British Isles Lupus Assessment Group (BILAG) score (if applicable), BILAG-Based Composite Lupus Assessment (BICLA) (if applicable), systemic lupus erythematosus responder index (if applicable), Lupus-quality of life and Functional Assessment of Chronic Illness Therapy-Fatigue, anti-double stranded deoxyribonucleic acid antibody and anti-nuclear antibody levels and plasma complement levels (C3, C4), erythrocyte sedimentation rate and C-reactive protein.
  * Peripheral blood B and T cell subsets.

The total duration of screening to end of study per subject is 16 weeks with post-study observation on Day 198 for anti-drug antibody assessment (for patients with positive anti-drug antibody at end of study only).

Eligibility Criteria:
Inclusion criteria:

* Male or female patients, between 18 and 75 years of age, inclusive.
* Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
* Autoantibody-positive.
* On active and stable SLE disease.
* B cell subsets expressed as percentage of total B cells above normal.

Exclusion criteria:

* Pregnant and nursing.
* Have received treatment with investigational drugs in the 4 months prior to the screening or 5 half-lives of the drug, which ever is longer.
* Have received intravenous or oral cyclophosphamide within 180 days of Day 0.
* Severe active lupus nephritis or chronic renal insufficiency.
* Active or chronic, severe neuropsychiatric lupus.
* Acute, recent (within 4 weeks of screening), chronic or frequently recurring infection(s), except minor infection.
* Have current drug or alcohol abuse or dependence.
* Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Effect of Lysulin on Glycemic Control and Advanced Glycation

The primary objective is to determine whether 12 weeks of treatment with Lysulin, compared to placebo, causes a reduction from baseline in the plasma levels of glucose, hemoglobin A1c (HbA1c) and Advanced Glycation Endproducts (AGEs) in patients with inadequately controlled type 2 diabetes mellitus. Secondary objectives include determining whether 12 weeks of treatment with Lysulin increases beta-cell function as measured by plasma C-peptide levels.

Objective(s): The primary objective is to determine whether 12 weeks of treatment with Lysulin, compared to placebo, causes a reduction from baseline in the plasma levels of glucose, hemoglobin A1c (HbA1c) and Advanced Glycation Endproducts (AGEs) in patients with inadequately controlled type 2 diabetes mellitus. Secondary objectives include determining whether 12 weeks of treatment with Lysulin increases beta-cell function as measured by plasma C-peptide levels.

Research Plan: A randomized, prospective, double-blind study with randomization to lysulin and placebo in a 1:1 fashion. The study will enroll 60 patients with inadequately controlled type 2 diabetes.

Methods: The study will be performed as outpatient study at Phoenix VA Clinical Research Center. The study will include 3-4 visits. At the initial visit, participants will complete informed consent proc HbA1c ≥ 7.5 % and \< 10%ess and undergo screening examination. Inclusion criteria will be age 21-75 years, HbA1c ≥ 7.5 % and \< 10%, and stable dose of insulin 6 weeks prior to enrollment. Qualified participants will be randomized to 3,330 mg/day Lysulin (1,110 mg tbl, TID) as add-on supplement therapy for 12 weeks. Follow-up visits will be at weeks 6 and week 12 (end of study). Baseline and follow-up visits will include physical examination, patient history and blood draw. The primary study outcome measure will be fasting plasma glucose and HbA1c. Secondary outcome measures will include fasting plasma C-peptide and AGE concentrations. A linear mixed effects model will be used to evaluate treatment-induced endpoints. The models will be fit for sequential values of the response variable (including the baseline measurement).

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* HbA1c ≥7.5% and \<10.0% within past 6 weeks on diet only or stable doses of oral antihyperglycemic agents with or without insulin
* stable body weight (\< 5% change in last 3 months)
* If on insulin therapy: \< 20% variation in insulin units 6 weeks prior to the study.

Exclusion Criteria:

* Type 1 DM
* current or recent use of supplements containing lysine, zinc or vitamin C
* uncontrolled hypertension (blood pressure ≥160/90 mmHg)
* kidney disease (serum creatinine GFR ≤50 mL/min)
* major illness
* severe gastrointestinal disease
* pregnancy
* liver function tests \> 2.5 times normal values in the past 3 months
* currently abusing alcohol or drugs, or have a history of alcohol or drug abuse that in the investigator's opinion could cause the subject to be non-compliant; or have a general history of non-compliance with medications
Intermediate Vision in Patients With Clareon IOLs Compared to Eyhance IOLs

Compare visual outcomes in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.

This is a non-interventional prospective, comparative study of the outcomes for patients following successful, uncomplicated cataract surgery. All patients will have had bilateral implantation of an Eyhance IOL (DIB00/DIU\*\*\*) or Clareon IOL (CNA0T0) at the time of uncomplicated cataract surgery. These patients will then be assessed post-operatively to compare distance and intermediate visual acuities and a defocus curve in patients with bilateral Clareon Monofocal IOLs versus bilateral Eyhance IOLs.

Patients will be assessed for corrected binocular distance and intermediate vision.

Eligibility Criteria:
Inclusion Criteria:

1. Adults, 40 years of age having already undergone uncomplicated cataract removal by phacoemulsification with a clear corneal incision in both eyes.
2. Implantation of bilateral Clareon intraocular lenses or Eyhance intraocular lenses (DIB00/DIU\*\*\*).
3. Able to comprehend and willing to sign informed consent and complete all required testing procedures
4. Best Corrected Distance Visual Acuity (BCDVA) projected to be 0.10 logMAR (Minimum Angle of Resolution) or better
5. Clear intraocular media
6. Minimum of two weeks post yttrium aluminum garnet laser capsulotomy to treat PCO

Exclusion Criteria:

1. Any corneal abnormality, other than regular corneal astigmatism (as determined by pre-operative testing) that in the opinion of the investigator would confound the outcome(s) of the study
2. Any complication during cataract surgery (capsular tear, vitrectomy, etc)
3. History of or current retinal conditions in either eye that would confound the results of this investigation in the opinion of the investigator (e.g. retinal detachment, epiretinal membrane, retinal ischemia, retinal inflammation, etc)
4. Amblyopia or strabismus in either eye
5. History of or current anterior or posterior segment inflammation of any etiology
6. Any form of neovascularization on or within the eye
7. Glaucoma (uncontrolled or controlled with medication)
8. Optic nerve atrophy
9. Subjects with diagnosed degenerative eye disorders
10. Postoperative CDVA worse than 0.10 logMAR (20/25 snellen) in either eye.
11. Subjects who have an acute or chronic disease or illness that would confound the results of this investigation in the opinion of the investigator (e.g. immunocompromised, connective tissue disease, clinically significant atopic disease, etc)
Examining tDCS Effect on Cannabis Use Disorder in Patients With Schizophrenia

Cannabis use disorder is a frequent comorbidity of schizophrenia, associated with increased symptoms and less adherence to therapy. Validated care has limited effectiveness in this population and development of new management strategies seems necessary. Transcranial direct current stimulation (tDCS) has shown beneficial effects in both schizophrenia, substance use disorder and, in a less extent, in nicotine addiction in schizophrenic subjects. It is interesting to test if that 10 sessions of anodal stimulation of the right dorsolateral prefrontal cortex (DLPFC) and cathodal stimulation of the medial prefrontal cortex (MPFC) (by increasing control and modulating reward system), will reduce, in 110 schizophrenic subjects, cannabis consumption, and secondly craving, addiction severity, schizophrenic symptoms and improve global functioning. It is possible that these clinical effects will be associated with changes in certain cognitive functions and cerebral connectivity.

Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays.

The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia diagnostic according to DSM (Diagnostic and Statistical Manual of mental disorder) 5 criteria, without change in psychotropic treatment since at least 4 weeks
* Moderate to severe cannabis use disorder according to DSM 5 criteria and active consumption during the last 7 days
* Subjects motivated to reduce or quit their cannabis consumption
* Patients with ambulatory compulsory care may be included

Exclusion Criteria:

* Other substance use disorder, excluding nicotine, according to DSM 5 criteria
* Other current psychiatric disorder according to DSM 5 criteria, excluding personality disorder
* Inpatient hospitalization
* History of head injury, neurological disorder with cerebral consequence or severe unstable somatic disorder
* Pregnancy or no contraception
* Contraindications for tDCS and/or MRI (implanted material, uncontrolled epilepsy, intracranial hypertension)
Cadonilimab Plus FOLFOXIRI and Bevacizumab as First Line Therapy for Metastatic MSS Colorectal Cancer

Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors.

This was a phase II study of cadonilimab in combination with bevacizumab and FOLFOXIRI as first line therapy for metastatic microsatellite stable (MSS) colorectal cancer. The goal of this clinical trial is to evaluated the efficacy and safety.

Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors.

This was a phase II study of cadonilimab in combination with bevacizumab and FOLFOXIRI as first line therapy in patients with metastatic microsatellite stable (MSS) colorectal cancer. The goal of this clinical trial is to evaluated the efficacy and safety.

Cadonilimab (6mg/kg, iv, Q2W, Day1)+irinotecan\* 165 mg/m² iv continue for 1.5 hours, D1; oxaliplatin 85 mg/m² iv continue for 2 hours, D1; leucovorin 400 or levoleucovorin 200 mg/m² iv continue for 2 hours, D1; 5-FU 2400 mg/m² cont. inf. 48h; repeat every 2 weeks (Q2W) + bevacizumab （5mg/kg，d 1）

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic pMMR or MSS colorectal adenocarcinoma. Note: MMR or MSI status will be performed locally by an immunohistochemistry (IHC) or PCR based test for eligibility.
* Patients who are naïve to systemic treatment in metastatic setting.
* Patients with previous neoadjuvant or adjuvant chemotherapy (that may have included oxaliplatin or investigational VEGF inhibitors) are eligible if the treatment was completed \> 12 months before inclusion.
* Patients with the presence of at least one lesion with measurable disease as per RECIST 1.1 guidelines. Lesions in previously irradiated areas should not be considered measurable unless they have clearly progressed since the radiotherapy.
* Patients have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* Patients with MSI-H colorectal adenocarcinoma as defined per local assessment using standard of care testing
* Patients with metastatic disease amenable to be resected with potentially curative surgery
* Patients who have received any systemic treatment for metastatic disease.
* Patients with a history of prior treatment with anti-PD-1, anti-PD-L1, anti-PDL2, anti-CTLA-4 antibodies, other checkpoint inhibitors
* Patients who had received radiation within 14 days prior to the first dose of study drug
Total Dose Infusion of Ferumoxytol(1020mg) in 15 Minutes for Iron Deficiency Anemia

The aim of the study is to recruit 30 patients who have been referred to Auerach Hematology Oncology Assoc. for the treatment of iron defeciency anemia with iv iron (Ferumoxytol 1020 mg) administered via infusion pump over 15 minutes.

To ascertain acute safety and tolerability of ferumoxytol during immediate post dosing observation period.

Assess additional safety profile and laboratory assessment at follow up visit and interim telephone follow up.

Ferumoxytol, a modified iron dextran, which allows the rapid administration of IV iron without free iron release, was approved for a 510 mg injection to be administered in not less than 17 seconds. Although this represents a felicitous treatment for patients who come frequently, such as dialysis and chemotherapy patients, multiple publications suggest that full dose replacement is usually at the 1000 mg level. No studies extant are available with this dosing schedule for ferumoxytol. In this trial, iron deficient patients with hemoglobin levels of \<11.0 grams per deciliter will be consented to received 1020 mg (two 510 mg vials) of ferumoxytol in 15 minutes. Vital signs will be performed at 5, 10, 15, 30 and 60 minutes. Followup phone calls for any clinical adverse events will be made at 24-48 hours and one week after administration. At four weeks follow-up hematologic and serologic (iron parameters) will be made along with a physician visit.

Eligibility Criteria:
Inclusion Criteria:

* Iron deficiency anemia intolerant of or failure to respond to oral iron or condition where oral iron is known to be ineffective or harmful.
* Subject must be able to be contacted at 24-48 hours after dose and come for followup at four weeks.
* Subject must be capable of understanding informed consent
* No other form of iron may be taken within four weeks of consent or for four weeks after treatment

Exclusion Criteria:

* History of hypersensitivity to ferumoxytol.
* Imminent dialysis.
* Anemia due to other etiology.
* Parenteral iron within 4 weeks of consent.
* Pregnancy.
* Erythropoiesis stimulating agent within 30 days of consent.
* Other illness that would interfere with participation or understanding of trial.
* Major surgery planned within four weeks of consent.
Parental Anxiety and Postoperative Pain and Complications in Children Undergoing Tonsillectomy ± Adenoidectomy

It is aimed to understand whether high parental anxiety leads to increased pain in children undergoing tonsillectomy ± adenoidectomy surgery and whether it increases the development of complications.


Eligibility Criteria:
Inclusion Criteria:

* 4-15 years old child patient
* Willingness to participate in the study by the patient and/or parent
* No history of psychiatric-mental illness or drug use in the patient and/or parents
* The patient has no craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
* No bleeding disorder or disease

Exclusion Criteria:

* \<4 years old, \>15 years old paediatric patients
* Not wanting to participate in the study at any stage of the study
* History of psychiatric-mental illness or drug use in the patient and parents
* The patient has craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
* Having a bleeding disorder or disease
Study on the Decision Support System of Difficult Airway Evaluation

Based on the evaluation of preoperative physical indicators and radiologic indicators of cervical surgery, this study puts forward effective indicators for predicting difficult airway before operation, and establishes a comprehensive decision support system of difficult airway evaluation, so as to provide a theoretical basis for the early warning of difficult airway before cervical spondylosis surgery.

In the past, the evaluation of difficult airway mainly depended on physical indicators, but the internal structure of airway could not be found by appearance inspection. Therefore, unexpected emergency airway often appeared in clinical work, which seriously affected medical safety. In this study, the specific mechanism of difficult laryngoscopy in patients undergoing cervical spondylosis surgery is clarified by the combination of the physical indicators and radiologic indicators. On this basis, we will establish the preoperative airway evaluation system for cervical spondylosis surgery, optimize the standardized process of preoperative airway evaluation, and accurately screen out high-risk patients.

Eligibility Criteria:
Inclusion Criteria:

* patients of ASA I-III
* scheduled for elective surgery for cervical spondylosis under general anesthesia with tracheal intubation

Exclusion Criteria:

* patients with cervical spine instability
* oropharyngeal mass
* airway disease
* preoperative imaging data were incomplete
* refuse to sign informed consent
Pegasys® Plus Ribavirin in Thalassemic Patients With Hepatitis C Virus Infection

Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.

Patients with Thalassemia receive chronic blood transfusions and have an increased prevalence of chronic Hepatitis C virus (HCV) infection, particularly if transfused before HCV serological testing became available. The investigators enrolled 300 patients into the study. The patients received PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 1000 milligram for weight less than or equal 75 kg and 1200 milligram for more than 75 kg for 48 weeks. Follow up period is 6 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the third months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.

Eligibility Criteria:
Inclusion Criteria:

* HCV RNA positive
* Age older than 12 years

Exclusion Criteria:

* Ongoing pregnancy or breast feeding
* History (Hx) of Hepatocellular Carcinoma (HCC)
* Hx of alcoholic liver disease
* Hx of bleeding from esophageal varices
* Hx of hemochromatosis
* Hx of autoimmune hepatitis
* Hx of Suicidal attempt
* Hx of cerebrovascular dis
* Hx of severe retinopathy
* Hx of severe psoriasis
* Hx of scleroderma
* Hx of metabolic liver disease
* Hx of Systemic Lupus Erythematosus (SLE)
Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss

In-office applied non-thermal atmospheric pressure plasma treatment on NS pretreated scalp


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mild-to moderate androgenetic alopecia
* ability to keep in-person follow-up appointments

Exclusion Criteria:

* any inflammatory scalp condition
* starting or discontinuing any hair loss treatments within 6 months of start date
* allergy to any components of the carrier solution
Beta Blocker Use in Cardiac Surgery and Association With Postoperative Course

The objective of this study is to describe in a cohort of cardiac surgery patients the use of beta-blockers before surgery and their maintenance or withdraw according to international recommendations in order to compare patients who receive a beta-blocker with maintenance during the surgical period (international recommendation) to those for whom prescription and maintenance are not respected. Patients are treated according to standard practice and this protocol does not change patient management. No additional information or data is required by the study other than the data usually collected in the patient record (drug treatment, medical history, operating data, postoperative data, complications, length of stay).

The objectives of this research are :

* To evaluate the proportion of patients receiving beta-blocker treatment prior to cardiac surgery.
* To evaluate the proportion of patients receiving beta-blocker treatment before cardiac surgery and complying with international recommendations for its maintenance/stop in perioperative cardiac surgery.
* To evaluate the incidence of complications and length of hospital stay in patients receiving beta-blockers based on compliance or non-compliance with recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Major patient ≥ 18 years
* Patient operated cardiac surgery with cardiopulmonary bypass
* Patients who have given oral consent to participate after full information

Exclusion Criteria:

* Off pump cardiac surgery
The Effect of Anesthesia Management on Optic Nerve Sheath Diameter in the Ercp Procedures

Aim: To compare the effect of procedural anesthesia management with ketofol and propofol on the sonographic optic nerve sheath diameter in the endoscopic retrograde cholangiopancreatography (ERCP) procedures.

Adequate visualization of the gastrointestinal mucosa during endoscopic retrograde cholangiopancreatography (ERCP) requires distention of the intestinal lumen by gas insufflation. High intraluminal pressures can increase intraabdominal pressure, leading to an increase in intracranial pressure. Ultrasonographic measurement of the optic nerve sheath diameter is a simple, non-invasive, and reliable technique for assessing intracranial pressure. Propofol, a sedative-hypnotic agent with rapid onset and short duration of action, is often used.Theoretically, the combination of ketamine and propofol may maintain sedation efficacy while reducing cardiovascular side effects through dose reduction and due to its synergistic effects.

The aim of this study is to demonstrate whether our anesthesia management has an effect on ICP change by measurement of optic nerve sheath diameter, predicting that insufflation performed for imaging during the ERCP procedure increase intraabdominal pressure, and frequently observed situations such as insufficient sedation, prone position, coughing and Valsalva during the procedure increase intracranial pressure (ICP).

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing ERCP procedure
* ASA score of I, II, and III

Exclusion Criteria:

* chronic lung disease
* renal or hepatic failure
* uncontrolled comorbidities (diabetes mellitus, hypertension, etc.)
* central nervous system disease
* pregnancy
* undergoing optic nerve surgery
* glaucoma or increased intraocular pressure, and retinal detachment