cyrilzakka/clinical-trials huggingface dataset:
The Application of Remazolam in Gastroenteroscopy

OBJECTIVE: To study the safety, efficacy and clinical significance of remimazolam in the diagnosis and treatment of patients with daytime gastrointestinal endoscopy, calculate the optimal dose, and conduct relevant verification. Provide a safer and more effective anesthesia solution for the growing special population.

METHODS：Around 160 patients were selected to receive painless gastroenteroscopy.，they were divided into four groups of D1, D2, R and C. Group D1 and D2(including 60 patients) were used to calculate the ED50 and ED95 of the drug. According to up-and-down method, they were slowly injected 0.3μg/kg of remifentanil in advance, then 0.20mg/kg of remimazolam, and gastroscopy was performed after MOAA/S score ≤３. The next patient would be increased 0.05mg/kg of remimazolam if there is a positive standrd, otherwise it would be decreased 0.05mg/kg. And the study was terminated when seven crossing points occurred. One hundred patients were randomly divided into two groups of R and C.Before administration of remimazolam, remifentanil injection 0.3 μg/kg were given intravenously in two groups, respectively (injection rate was 30 s).Then group R was given the calculated dose of remimazolam, and group C was given propofol 1.5-2mg/kg.The success rate of sedation, changes in vital signs, adverse reactions, and postoperative recovery were recorded in the two groups.

The study used up-and-down methods to calculate the ED50 and ED95. According to up-and-down method, group D1 and D2 were slowly injected 0.5μg/kg of remifentanil in advance, then 0.20mg/kg of remimazolam, and gastroscopy was performed after MOAA/S score ≤３. The standard for a positive response in patients undergoing gastroscopy: coughing, swallowing, frowning, and physical movement affecting the operation during the examination. The next patient would be increased 0.05mg/kg of remimazolam if there is a positive standrd, otherwise it would be decreased 0.05mg/kg.And the study was terminated when seven crossing points occurred. Probit regression analysis method was used to calculate the ED50, ED95 and 95%CI of remimazolam combined with remifentanil in painless gastroenteroscopy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old; ASA classification I-II grade

Exclusion Criteria:

* Asthma; allergic to the drugs involved and contraindicated; patients with severe respiratory system, cardiovascular system diseases and coagulation insufficiency of liver and kidney function; patients with severe neuropsychiatric system diseases
Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered

The purpose of this study is to evaluate pharmacokinetics, safety and tolerability profile of BZ371A topically administered in healthy patients.

Prostate cancer remains one of the most prevalent cancer in men. For its treatment, recent technological advances demonstrate that the most effective treatment is the Radical Prostatectomy (RP) procedure. However, although curative for Prostate Cancer, can result in damage to the cavernosal nerves.

The cavernosal autonomic nerves travel posterolaterally to the prostate to enter the penis and regulate blood flow and hence erection. Thus, damage caused by RP will affect NO tissue release and blood flow regulation, causing erectile dysfunction.

BZ371A has the ability to restore local blood flow regulation by a new and innovative mechanism of action and, therefore, has potential to be a supportive therapy for RP patients (restoring the erectile function).

Thus, this study has the purpose to evaluate safety, tolerability and pharmacokinetics of a BZ371A single dose, topically administrated at the genital area.

Eligibility Criteria:
Inclusion Criteria:

* Men or women
* Body mass index \> 19 and \< 28.5 Kg/m2
* Is able to understand the Informed Consent Form (ICF)

Exclusion Criteria:

* Women in their menstrual period;
* Diseases that interfere with the absorption, distribution and excretion of drugs, such as history or presence of hepatic or renal diseases;
* Presence of active genital lesions or sexually transmitted disease (STD) (such as herpes, gonorrhea, candidiasis, Human Papillomavirus, and others) that impair analysis of local adverse effects on the genitalia;
* History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patients with heart disease (including a history of angina and/or heart failure) and nephropathies;
* Findings on ECG and/or laboratory tests that, in the investigator's judgment, are considered the research volunteer's participation or may interfere with the analysis of the study of the study;
* Blood pressure (BP) outside the limits considered safe: systolic BP (SBP) 90 - 140 mmHg and diastolic BP diastolic BP (DBP) 60 - 90 mmHg, except for situations such as "white coat syndrome";
* Any disease or condition or physical finding that the investigator considers significant and that increases the risk
* Any disease or condition or physical finding that the investigator considers significant and that increases the risk of participation of the research volunteer or may interfere with the results.
Involvement of the Sodium Pump and Endogenous Digitalis-like Compounds in Bipolar Disorder

This study deals with the possible molecular mechanisms that underlie the etiology of bipolar disorders (BD). Previous studies have implicated Na+, K+-ATPase and endogenous digitalis-like compounds (DLC) in the depressive state of this disease. The possibility, however, that they are also involved in the manic phase of the disease was never addressed. The results of this study may have significant implications for the treatment of BD by DLC derivatives.

Depressive symptoms are the hallmark major depressive disorder, dysthymia and bipolar depression within the context of bipolar disorder (BD). They share clinical characteristics including depressed mood, anhedonia, and low energy and require medical treatment. The Na+, K+-ATPase is a major transporter in the plasma membrane which has an important role in regulating cell volume, cytoplasmic pH and Ca++ levels. Digitalis-like compounds (DLC); steroids identified as normal constituents of human brain, plasma and other tissues, exclusively interact with the Na+, K+-ATPase and induce numerous biological effects. We raised the hypothesis that Na+, K+-ATPase/DLC system is involved in BD based on studies from ours and other laboratories, which tested the involvement of this system in the depressive state of BD. The possibility that the interaction of DLC with the Na+, K+-ATPase is involved in the manic state of BD was scarcely investigated. To address this issue we intend to determine circulating DLC levels in patients with BD at different states of the disease;

Eligibility Criteria:
Inclusion Criteria:

* BIPOLAR DISORDER PATIENTS

Exclusion Criteria:

* NONE
A Study of IBI363 in Subjects With Advanced Melanoma

This is an open-lable, multicenter Phase II study to evaluate the safety, tolerability, and efficacy of IBI363 in advanced melanoma patients


Eligibility Criteria:
Inclusion Criteria:

1. Histologically and/or cytologically confirmed, unresectable, locally advanced or metastatic melanoma (according to the American Joint Committee on Cancer (AJCC) 8th edition staging III-IV). Progression or recurrence after at least first-line systemic standard treatment.
2. At least one measurable lesion (target lesion) per RECIST v1.1.
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
4. Life expectancy of 3 months or more.
5. Female subjects of childbearing age or male subjects whose partners are female subjects of childbearing age agree to strictly adopt effective contraceptive measures throughout the entire treatment period and 6 months after the treatment period.

Exclusion Criteria:

1. Pregnant or lactating subjects, or subjects who plan to conceive before, during, or within 6 months after the last dose of the study drug.
2. Active or symptomatic central nervous system metastasis.
3. At baseline (within 7 days before the first administration of the study drug), there were any hematological abnormalities as follows: hemoglobin\<90 g/L; Absolute neutrophil count (ANC)\<1.5 × 109/L; Platelet count\<100 × 109/L.
4. At baseline (within 7 days prior to first administration), there were any serum biochemical abnormalities as follows: Total bilirubin\>1.5 × ULN; AST or ALT\>3 × ULN; If it is tumor liver metastasis, AST or ALT\>5.0 × ULN; Serum creatinine\>1.5 × ULN or CCr\<45 mL/min, using the Cockcroft Fault formula to calculate CCr (using actual body weight); Albumin\<30 g/L.
5. At baseline (within 7 days before first administration), there were any coagulation parameter abnormalities as follows: INR\>1.5 × ULN (\>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN); PTT (or activated partial thromboplastin time (aPTT))\>1.5 × ULN (\>3 if receiving anticoagulant therapy with stabilizer dosage) × ULN).
6. History of active thrombosis, deep vein thrombosis, or pulmonary embolism within 4 weeks prior to the first administration of the investigational drug, unless sufficient treatment has been given and the investigator believes that the condition is stable.
7. Uncontrolled bleeding or known tendency to bleed.
Evaluation of Sun Protection Education for Kidney Transplant Recipients

This study is being done to evaluate the effectiveness of a Sun Protection Strategies workbook for kidney transplant recipients. Since the medication taken to preserve the kidney transplant puts kidney transplant recipients at an increased risk of developing skin cancer. The program will help people learn about how to practice effective sun protection after the transplant.

Cognitive interview about the Sun Protection Strategies workbook will be performed with up to 25 kidney transplant recipients (KTR) who have participated in past surveys. A second phase of the study involves 156 KTRs that will be asked to take part in a randomized controlled trial evaluating the fully developed sun protective strategies workbook.

Kidney transplant recipients (KTRs) are at risk to develop skin cancer. Adequate sun protection after transplantation can reduce the risk of developing skin cancer. In 2006, the National Kidney Foundation (NKF) found that sun protection education delivery and content varied among transplantation centers. Clinicians rarely knew when to initiate education about skin cancer risks and prevention including timing and scope, and rarely demonstrated understanding of the importance of reminders for and repeated education of patients (National Kidney Foundation 2006).

Aims:

1. To explore culturally sensitive use of terms describing ethnic cultural perceptions of sun burning, pigment darkening after sun exposure and description of skin color by the amount of photo-protective pigment in the skin.
2. To pilot test the sun protection workbook with English speaking KTRs representing the 3 ethnic groups: White, Black and Hispanic.
3. To assess the effectiveness of an education intervention encouraging the use of sun protection strategies.
4. To explore understanding of the importance of sun protection and the KTRs confidence in their being able to practice sun protection.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a history of kidney transplantation within the last 2-24 months
* Speaks English
* Can see to read
* Lives in the greater Chicago area and can attend two study visits
* 18-85 years old

Exclusion Criteria:

* Unable to speak English
* Cognitive impairment or neurologic disease
* Dementia or insufficient cognitive skills to follow instructions provided at a sixth grade language level
* Has had a skin cancer
Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2

The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.

Dry eye can be caused by many variable factors. Some examples include hormonal changes due to aging, or living in an environment of low humidity for long periods of time. Dry eye is a complex disease that may result in symptoms like discomfort, visual disturbance, and dryness. Patients with dry eye often have damage on the surface of the eye. In previous studies, RGN-259 has been shown to promote healing of the surface of the eye and decrease inflammation. It suggests that RGN-259 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a subject reported history of dry eye for at least 6 months
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months

Exclusion Criteria:

* Have any clinically significant slit-lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have ab uncontrolled systemic disease:
Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer

This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer

This study aims to investigate the therapeutic efficacy of PIPAC using doxorubicin and cisplatin in women with recurrent ovarian cancer and disease progression with peritoneal carcinomatosis. The primary objective of this study is to determine the Clinical Benefit Rate (CBR) according to RECIST criteria after three cycles of PIPAC with cisplatin and doxorubicin.

Eligibility Criteria:
Inclusion Criteria:

* at least 2 lines of previous chemotherapy
* recurrent ovarian cancer
* patient is mobile
* informed consent

Exclusion Criteria:

* ileus
* necessity of parenteral nutrition
Adiponectin and Circulating Progenitor Cells (CPC) Function

Adiponectin and exercise training contribute to the maintenance of a normal vascular tone by influencing vascular NO bioavailability and concentration and function of endothelial progenitor cells. The molecular mechanisms are only partially understood. Therefore, aim of the present study is to elucidate the effects of Adiponectin on endothelial progenitor cell migration and the underlying signaling pathways. Furthermore, the impact of exercise training on adiponectin-mediated endothelial progenitor cell migration will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* ≤ 75 years of age
* stable coronary artery disease
* preserved left ventricular function
* physical work capacity of ≥ 50
* successful elective percutaneous coronary intervention at study begin

Exclusion Criteria:

* diabetes mellitus
* hypercholesterolemia
* untreated hypertension
* smoking
* myocardial infarction within the last 4 weeks
* significant stenosis of the left main coronary artery
Duration of Clopidogrel Therapy After Drug-Eluting Stent (DES-LATE)

This is randomized-controlled trial to evaluate the difference of composite of cardiac death, myocardial infarction, or Stroke between the dual antiplatelet therapy group and the aspirin monotherapy group after 1-year of drug-eluting stents implantation.

This is subsequent clinical trial of previously published pooled analysis of the REAL-LATE and the ZEST-LATE Trial, in which nonsignificant higher trend for increased rate of death (all-cause and cardiac), myocardial infarction, or stroke in the dual antiplatelet therapy group compared to the aspirin monotherapy group was noted.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients had undergone DES implantation at least 12 months before enrollment, had not had a MACE (death, MI, stroke, or repeat revascularization) or major bleeding, and were dual-therapy at the time of enrollment.
* 2. Time for index PCI to randomization: 12-18 months

Exclusion Criteria:

* Contraindications to the use of antiplatelet drugs (e.g., a concurrent bleeding diathesis or a history of major bleeding)
* Concomitant vascular disease requiring long-term use of clopidogrel
* Other established indications for clopidogrel therapy (e.g., a recent ACS).
* Noncardiac coexisting conditions with a life expectancy \< 1 year.
Treatment of Pruritus With Intramuscular Promethazine

Neuraxial narcotics are commonly used in obstetric patients for cesarean delivery to help with pain control over the first 24 hours after the surgery. The aim is to evaluate effectiveness of promethazine (IMP) treatment of intrathecal morphine induced pruritus (ITIMIP). A treatment for ITMIP, other than naloxone, will allow for increased use of intrathecal narcotics and decrease the use of systemic opioids in the initial post-operative period.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant adult female patients of at least 18 years of age consenting to a cesarean birth
* Willing to consent to study.

Exclusion Criteria:

* Male patients
* Incarceration
* Inability to communicate with the investigators
* Allergies to any medications used in the study
* Possessing any contraindication to spinal anesthesia (lack of consent, elevated intracranial pressure, preexisting neurological disease, thrombocytopenia/coagulopathy, hypovolemia, infection at the site of the procedure)
* Patients with an already prolonged QTc (\>500 ms)
* Any reason an investigator believes study participation would not be in the best interest of the potential subject.
Study of Patient Navigation to Promote Colon Cancer Screening

This study will investigate whether patient navigation can increase rates of colorectal cancer screening among linguistically and culturally diverse disadvantaged patients served by urban community health centers.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 52-75 who had one visit to a primary care physician in a community health center in each of the 2 previous years and who have not received colorectal cancer screening based on HEDIS criteria.

Exclusion Criteria:

* Current cancer diagnosis, undergoing treatment (or treatment completed within the past year)
* Severe cardiac disease (high-risk CAD,9 valvular disease, NYHA Class III or IV CHF, EF \< 35%)
* Severe COPD (FEV1\< 1liter or on home oxygen)
* CVA with severe functional impairment (aphasia or hemiparesis)
* MS with severe functional impairment
* Renal failure with CrCl\< 30 or on dialysis
* Gastrointestinal symptoms (pain, bleeding, etc) within the past 6 months
* Chronic active liver disease or cirrhosis, with albumin \< 3 or elevated INR
* Advanced HIV disease (CD4 count \<200)
* Severe lupus (with cerebritis or renal failure as defined above)
* Severe complications of diabetes (blindness, amputations other than toes)
* Advanced Dementia
* Psychosis
* Paranoia
* Active substance abuse
* Schizophrenia
* Psychiatric hospitalization within the past year
Nivolumab +/- Ipilimumab Immunomonitoring in Metastatic Melanoma

This is an open bi-centric prospective non-randomized study in patients with metastatic melanoma treated with a first line treatment of Nivolumab +/- Ipilimumab. The aim of the study is to characterize the immune cells modulations under anti-PD-1 +/- anti-CTLA4 and identify the differences between responder and non-responder patients.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥ 18 years of age.
* Patient with metastatic or unresectable melanoma
* Nivolumab or Nivolumab + Ipilimumab treatment indication
* Skin biopsies available
* Patient affiliated to or a beneficiary of a social security category.
* Signed Written Informed Consent.
* Patient who agrees to the storage of his biological samples

Exclusion Criteria:

* Treated haematological malignancies Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
* Patients with autoimmune disease.
* Ocular melanoma
Esketamine Combined With PRF for Trigeminal Postherpetic Neuralgia

This trial's primary objective is to compare the analgesic efficacy of esketamine in combination with pulsed radiofrequency (PRF) against that of PRF monotherapy in patients with trigeminal postherpetic neuralgia (TPHN).

This study aims to determine whether the addition of esketamine to the PRF regimen can relieve pain in TPHN patients. By doing so, the research endeavors to identify a rapid, effective, and safe treatment approach for refractory TPHN patients

Eligibility Criteria:
Inclusion Criteria:

1. Ages more than 18 years;
2. Pain persisting for over three months following the onset of the herpes zoster skin rash;
3. Lesions located in the trigeminal nerve or its branches innervated regions；
4. Having an average pain score of at least 4 on a Numeric Rating Scale (NRS, 0 = no pain, 10= worst possible pain)；
5. Planned to perform CT-guided PRF treatment of the gasserian ganglion(GG).

Exclusion Criteria:

1. Obstructive sleep apnoea syndrome;
2. Those who receive other more invasive treatments, such as radiofrequency thermocoagulation (RFT) of GG.
3. A history of systemic immune diseases, organ transplantation, or cancers;
4. A history of severe cardiopulmonary, hepatic, renal dysfunction or coagulation function disorder;
5. A history of schizophrenia, epilepsy, or myasthenia gravis, delirium;
6. Comorbid hyperthyroidism or phaeochromocytoma;
7. Recent history of drug abuse;
8. Having contraindications to esketamine;
9. Communication difficulties.
10. Women who are preparing for pregnancy, in the pregnancy or lactation period.
Emergency Linkage to Outpatient Psychiatric Services

The purpose of this study is to compare two different kinds of follow-up care and their effects on psychiatric service use and psychological well-being. This randomized, controlled trial of subjects discharged from the psychiatric emergency services to outpatient care receive traditional hospital-based outpatient clinic referrals (treatment as usual) or appointments for community-based follow-up by a mobile crisis team.

There are subgroups of patients who only seek care in emergency settings. An effective strategy to link that group to ambulatory care involves extending contact with psychiatric emergency services beyond the initial hospital-based visit. The "window of opportunity" to promote successful treatment linkage is brief. This is a study of a novel treatment format that seeks to expand the concept of the emergency contact, the study patients method of entering the mental health system of care, and by doing this, enhance retention in prescribed outpatient care. The effects of the intervention on patient symptoms and mental health service use will be examined.

Eligibility Criteria:
Inclusion Criteria:

* English and Spanish-speaking adult patients (18-and above) presenting to the psychiatric emergency service who rate a "1" or higher on the Spectrum of Suicidal Behavior of Pfeffer screening scale, and who have outpatient followup organized by Comprehensive Psychiatric Emergency Program staff through hospital outpatient psychiatric services are eligible for inclusion.

Exclusion Criteria:

* Subjects less than 18 years old, those rated as not suicidal in the emergency department, subjects with mental retardation/developmental delay, and subjects who have community psychiatric treatment that they elect to continue in lieu of hospital outpatient psychiatric services referral are ineligible.