cyrilzakka/clinical-trials huggingface dataset:
A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy

A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open label arm for midazolam, in patients undergoing a bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients, aged ≥18 years, scheduled to undergo a diagnostic or therapeutic flexible bronchoscopy in the bronchoscopy suite (therapeutic bronchoscopies could include eg, lavage, biopsies, brushings, and foreign body extraction).
2. American Society of Anesthesiologists Physical Status Score (ASA PS) 1 through 3.
3. Body mass index (BMI) ≤ 45.
4. Peripheral blood oxygen saturation (measured by pulse oximetry: SpO2) ≥ 90% in ambient air or with no more than 2 L/min of oxygen support.
5. For all female patients, negative result of urine pregnancy test. Additionally, for women of child bearing potential only, use of birth control during the study period (from the time of consent until all specified observations were completed).
6. Patients voluntarily signed and dated an informed consent form that was approved by an IRB prior to the conduct of any study procedure, including screening procedures.
7. Patient was willing and able to comply with study requirements and available for a follow up phone call on Day Day 4 (+3/ 1 days) after the bronchoscopy.

Exclusion Criteria:

1. Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
2. Bronchoscopy outside the bronchoscopy unit (eg, intensive care unit).
3. Patients on mechanical ventilation.
4. Tracheal stenosis.
5. Planned laser bronchoscopy, rigid scope bronchoscopy.
6. Use of unstable doses of benzodiazepines and opioids for any indication, eg, insomnia, anxiety, or spasticity. An unstable dose means dose changes of more than 50% of the previous dose within 30 days prior to Day of procedure.
7. Female patients with a positive pregnancy test at Screening or Baseline and lactating female patients.
8. Patients with positive drugs of abuse screen (unless explained by concomitant medication) or a positive ethanol test at baseline.
9. Patient with a history of drug or ethanol abuse within the past two years.
10. Patients in receipt of any investigational drug or use of investigational device within 30 days or less than 7 t½ (whichever was longer) before the start of the study or scheduled to receive one during the study period.
11. Participation in any previous clinical study with remimazolam.
12. Patients with an inability to communicate well in English with the investigator or deemed unsuitable according to the investigator (in each case providing a reason).
Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections

The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the treatment of complicated intra-abdominal infections as compared to a comparator group.


Eligibility Criteria:
Inclusion Criteria:

* complicated intra-abdominal infections

Exclusion Criteria:

* infections limited to hollow viscus
* ischemic bowel disease without perforation
* acute suppurative cholangitis
* acute necrotizing pancreatitis
* pts to undergo stated abdominal repair, open abdomen technique or marsupialization
* Apache II \>25
Needs Assessment of Cancer Patients With Complementary and Alternative Medicines

The chronic cancer status, multidisciplinary and ambulatory care, as well as the cumbersome effects of the disease and treatments, lead patients to consider other options than those offered by traditional medicine, such as alternative medicine and complementary (CAM)

In order to put in place a policy on CAM based on the knowledge held by the patient and the health professionals, it is imperative to obtain and analyze the following information: why this type of medicine is used, what are its benefits, how does the patient get information and what are his sources, who practices them and how the patient perceives the place of the hospital and the various health professionals to develop and secure the use of CAM.

Our study will focus on CAM that can bring iatrogenic risk (phytotherapy, food supplements, acupuncture, traditional Chinese medicine, homeopathy, essential oils), and the following techniques: hypnosis and sophrology.

The study is carried out in two successive phases: the interview phase which will make it possible to obtain results to carry out the questionnaires phase. Patients who will be included in the interview phase will not participate in the questionnaire phase. Finally, patients who participate in the questionnaire phase will not have semi-structured interviews. They will only have to answer the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Woman and man over 18
* Francophone (speaking and reading French)
* Patient followed for the management of cancer, hospitalized or not, receiving or having already received a treatment cancer administered orally and / or systemically.

Exclusion Criteria:

* Patient who has not been treated for cancer with anticancer treatment
* Support in a palliative care service
* Refusal to participate in the study
* Patient under tutorship or curatorship
* Patient deprived of liberty
MAX-10181 Given Orally to Patients With Advanced Solid Tumor

This is a multi-center, first-in-human, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumor.


Eligibility Criteria:
Inclusion Criteria:

* Males and/or females over age 18.
* Histologically or cytologically confirmed advanced or metastatic solid tumor for which no established standard therapy is available.
* At least one measurable lesion by CT or MRI according to RECIST1.1, which is not in irradiated area (only for expansion phase).
* Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (in case of alopecia, Grade 2 is acceptable).
* Life expectancy of at least 3 months.
* Female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly.

Exclusion Criteria:

* Laboratory values not within the Protocol-defined range.
* Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
* Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry.
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
* Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery.
* Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
* Anti-cancer treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), hormone therapy, or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
* Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis.
* History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation.
* Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.
A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers

This is a single-dose, two-part, crossover formulation bridging and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal, healthy volunteers.

This is a single-dose, two-part crossover formulation bridging (Part A) and tablet food effect (Part B) study in normal, healthy volunteers. Part A will be conducted to evaluate the pharmacokinetics (PK) and relative bioavailability of 3 formulations of PBI-200; each volunteer will serve as their own control. In Part B, PBI-200 tablets will be dosed under fasting and fed (low-fat and high-fat meals) conditions to evaluate the effect of food on the PK of PBI-200.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female between 18 and 55 years of age (inclusive).
* Body Mass Index (BMI) between 18.0 and 32.0 kg/m² (inclusive).
* Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness.

Exclusion Criteria:

* History or presence of clinically significant cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease which, in the opinion of the Investigator, would jeopardize the safety of the volunteer or impact the validity of the study results.
* History of gastrointestinal/hepatobiliary or other surgery that may affect PK profiles (i.e., hepatectomy, gastric, bypass, or digestive organ resection).
* Intolerance to repeated venipuncture.
* Smoking or use of tobacco products (including vaping) within 3 months prior to the first study drug administration.
* Have a positive drug/alcohol screen, or history or presence of alcoholism or drug abuse within 6 months of first study drug administration.
* Volunteers with a corrected QT using Fridericia's formula (QTcF) prolongation over 450 milliseconds at Screening.
Platelet Rich Plasma During Radical Prostatectomy

Can platelet rich plasma applied to nerve bundles at time of surgery help the nerve bundles heal? Subjects undergoing a Radical Prostatectomy who meet study inclusion/exclusion criteria will be consented to receive an intraoperative application of platelet-rich plasma, made from their own blood at the time of surgery, for application onto their neurovascular bundles in an effort to improve the healing process. Subjects will be followed for an additional 18 months to determine the efficacy and safety of this procedure.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, clinically localized prostatic adenocarcinoma
* Age 50 - 60 years
* Male gender
* Normal preoperative sexual function
* Normal urinary continence
* Regular sexual partner

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Vulnerable study populations
* Active systemic infection
* Diabetes mellitus diagnosis
* Preexisting Erectile Dysfunction or urinary incontinence
* Metastatic or locally advanced prostatic adenocarcinoma on preoperative evaluation
* Men found grossly or pathologically to have locally advanced or metastatic disease at the time of radical prostatectomy
* An estimated blood loss of \> 750 mL at the time of radical prostatectomy
* Treatment prior to surgery with any form of hormones, anti-androgens or androgen deprivation therapy
* Use of an antidepressant, beta blocker or erectile dysfunction medication at the time of study screening
* Men without a regular sexual partner
* Use of aspirin or heparin 2 weeks before radical prostatectomy
* Need for use of aspirin or heparin for 2 weeks or more after radical prostatectomy
Randomized Study of Nivolumab+Ipilimumab+/- SBRT for Metastatic Merkel Cell Carcinoma

The purpose of this study is to test the effectiveness, safety, and tolerability of the drugs nivolumab plus ipilimumab with or without the addition of stereotactic body radiation therapy (SBRT). Nivolumab is an antibody (a type of human protein) that is being tested to see if it will stimulate the body's immune system to work against tumor cells. This study will test an investigational use of nivolumab.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2
* Active disease measurable by CT, MRI or clinical exam.
* Prior chemotherapy or immunotherapy will be allowed if new or persistent measurable site(s) of disease are present.
* Prior radiation therapy will be allowed if there is active measurable disease burden.
* Must be either recurrent, unresectable or Stage IV American Joint Committee on Cancer (AJCC) (7th edition) and have histologically confirmed Merkel cell carcinoma with at least 2 distinct lesions in order to be eligible.
* Must have at least 2 distinct lesions as documented by a complete physical examination or imaging studies within 4 weeks prior to randomization. Imaging studies must include a diagnostic CT scan of the involved disease sites and all known sites of resected disease and brain magnetic resonance (MRI) or CT (brain CT allowable if MRI is contraindicated or if there is no known history of resected brain lesions).
* Tumor tissue from the core biopsy or resected site of disease must be provided for biomarker analyses.

Exclusion Criteria:

* History of Grade 3 toxicity or use of infliximab with prior immunotherapy
* Patients with active brain metastasis.
* Active, known, or suspected autoimmune disease. Potential participants with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll.
* Patients with prior history of non-Merkel cell carcinoma malignancies are excluded except adequately treated basal cell, squamous cell skin cancer, chronic lymphocytic leukemia or other indolent diseases not requiring therapy; adequately treated, with curative intent, cancer from which the patient is currently in complete remission per investigator's judgment; or patients with history of breast cancer and no evidence of disease on hormonal therapy to prevent recurrence and patients with prostate cancer on adjuvant hormonal therapy with undetectable PSA are eligible.
* A condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia with an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients with Post-Menopausal Bleeding

This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions.

PRIMARY OBJECTIVE:

I. Prospective validation of an artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS) to identify patients with premalignant/malignant in a population of women with postmenopausal bleeding (PMB).

OUTLINE: This is an observational study.

Patients undergo a transvaginal ultrasound examination and endometrial sampling per standard of care and have their medical records reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 55 years
* At least one episode of postmenopausal bleeding (PMB)
* Endometrial biopsy available from at Mayo Clinic (MN, AZ, FL), Mayo Clinic Health System (MCHS), or an external institution
* Acceptance to participate in the study

Exclusion Criteria:

* Diagnostic tests performed more than 90 days apart
* Physical impediment/refusal to undergo transvaginal ultrasound (TVUS)
A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Skin Pruritus

The study is a Phase II, multi center, randomized, double-blind, placebo-controlled study in male and female subjects, aged ≥ 19 years with skin pruritus. All subjects will receive BID topical applications of PAC-14028 cream or vehicle for up to 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 19 - 70 years
* Patients who have eczema or xerosis cutis at the area where investigational product is applied (arm or leg)
* Patients whose result of the pruritus test (Visual Analogue Scale, VAS) at Visit 1 and 2 is 5 or more
* Patients whose overall dry skin score of the area where investigational product is applied at Visit 1 and 2 is 2 points or more

Exclusion Criteria:

* Patients with pruritus caused by other medical, psychotic and nervous causes other than the skin disease
* Patients with such skin diseases as malignant tumor or chronic urticaria among patients with skin diseases
* Patients with simple pruritus caused by such allergic material as scabies, and insect bite wound
* Patients with the symptom of systemic infection at the time of the participation in the clinical study
* Patients with a history of taking topical treatment drug, topical steroid agent or antibiotics for the treatment of pruritus within 2 weeks
* Patients with a history of taking oral steroid agent within 4 weeks
* Patients with a history of taking a physical treatment for the treatment of pruritus including phototherapy within 4 weeks
* Pregnant or breast-feeding women
* Women at a childbearing age who has childbearing potential or has a plan to get pregnant during the clinical study period
Early Assessment of Treatment Response Using Functional Diffusion Mapping

This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.

This study will evaluate a special type of MRI (magnetic resonance imaging) scan that measures the movement of water molecules through tissue called diffusion MRI. Researchers are using this new MRI technology to track the diffusion, or movement, of water through tumor tissue, and map these changes as a cancer patient undergoes treatment. Early research seems to indicate that tumor cells restrict the movement of water, so as tumor cells die, the movement of water changes within the tumor. These changes in the movement (diffusion) of water may help doctors determine earlier than traditional tests whether a patient's cancer is responding (getting better) to treatment. This study will evaluate the feasibility of identifying changes in diffusion MRI characteristics of bone that correlates with response to therapy in men with metastatic prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of prostate cancer.
* Evidence of metastatic disease by bone scan.
* Patients must be initiating systemic therapy for metastatic disease.
* New D2 disease beginning therapy with androgen deprivation.
* CRPC (Castration Resistant Prostate Cancer) beginning systemic non hormonal therapy.
* Patients must be willing to provide the blood samples for the correlative markers.
* Patients must be able to lie flat in an MRI (Magnetic Resonance Imaging) magnet for 30-60 minutes.
* Life expectancy of 12 weeks or greater.
* All patients must be informed of the investigational nature of this study and must sign an informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

* Contraindication to MRI imaging.
* Patients who require sedation with general anesthesia to undergo MRI imaging.
* Weight greater than 275 pounds.
Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

The purpose of this study is to determine whether administrating of Amantadine (a dopamine agonist) to patients suffering from Parkinson disease during the perioperative period is safe, and to asses potential benefits of this treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a diagnosis of Parkinson Disease refered for surgery at our institution.

Exclusion Criteria:

* Cardiac and neurosurgical procedures
* Inability to sign informed Consent
* allergy to Amantadine
* Congestive heart failure
* Arrythmia (including bradycardia below 55 bpm)
* renal failure (creatinin above 1.5)
* If a patient will develop agitation or delirium lasting longer then 8 hours he will not receive the second dose of amantadine.
Study Evaluating PAZ-417 in Cerebrospinal Fluid in Subjects With Alzheimer's Disease

The primary purpose of this study is to assess biomarker known as amyloid beta peptide 40 (Ab40) in Cerebrospinal Fluid (CSF), following a single oral dose of PAZ-417 in subjects with Alzheimer Disease (AD). This study will also consider another biomarker amyloid beta peptide 42 (Ab42) in Cerebrospinal Fluid in subjects with Alzheimer Disease and assess the safety, tolerability and pharmacokinetic profile of PAZ-417 in both plasma and Cerebrospinal Fluid in these subjects.


Eligibility Criteria:
Inclusion:

1. Men or women of non-childbearing potential, 55 years of age or older with a probable diagnosis of Alzheimer's Disease (AD), according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. Subjects will have AD that is mild to moderate in severity, as qualified by a score of 12 to 26 on the Mini-Mental State Examination (MMSE). Woman of non-childbearing potential must be either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal at least 1 year and must have a negative serum pregnancy test result within 48 hours before administration of test article. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
2. Body mass index in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
3. Subjects must be generally healthy, with the exception of AD but may be enrolled with a stable, chronic illness, if it is well controlled and does not interfere with the primary objective of the study. Subjects may be included with clinically important deviations from normal limits in medical history, physical examination findings, vital sign measurements, findings on 12 lead electrocardiogram (ECG), or chronic laboratory test results that are associated with stable, well controlled chronic illness.

Exclusion:

1. Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the test article.
2. Any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
3. History of vascular disorders (peripheral, coronary, venous), chronic inflammatory disorders (eg, rheumatoid arthritis), hematologic disorders, or bleeding disorders (eg, hemophilia, idiopathic thrombocytopenic purpura, VonWillebrand disease).
4. History of thrombotic events.
5. Presence or history of symptomatic vertigo, significant cardiac valvular disease, congestive heart failure, angina pectoris, significant cardiac arrhythmia, or seizures.