cyrilzakka/clinical-trials huggingface dataset:
Single Dose IV Methadone for Post-Op Pain

Single-center, open label, single-session study to evaluate methadone pharmacokinetics and pharmacodynamic in adults.

The Adult Methadone study will be conducted at a single site, Duke Early Phase Research Unity (DEPRU), to enroll 24 participants. Participants will be treated/monitored overnight with Methadone hydrochloride IV (FDA approved and commercially available), with daily follow-up visits for 1 week total. The study aims to provide information on the disposition and clinical effects of intravenous methadone to update the drug label.

Eligibility Criteria:
Inclusion Criteria:

1. 18 to \< 40 years of age at the time of enrollment
2. Provide informed consent

Exclusion Criteria:

1. History of cardiac dysfunction
2. History of or current QTc prolongation, defined as \> 470 ms in males and \> 480 ms in females
3. Known hypersensitivity to methadone hydrochloride or any other ingredient in the methadone hydrochloride injection
4. Known acute bronchial asthma or hypercarbia (known history of known PaCO2 above 45 mm HG)
5. Receipt of a serotonergic drug or buproprion within 7 days prior to study enrollment
6. Receipt of benzodiazepines, muscle relaxants, or other opioids within 7 days prior to study enrollment
7. Receipt of a moderate or strong CYP2B6 inhibitor or inducer - either prescription or non-prescription medications, herbals,34 or foods known to be metabolized by or affecting CYP2B6 - within 30 days prior to study enrollment

   1. CYP2B6 inhibitors include clopidogrel, prasugrel, thioTEPA, ticlopidine, voriconazole, macrolide antibiotics, azole-antifungal agents, fluconazole, Alstonia boonei, Mangifera indica, and Picralima nitida
   2. CYP2B6 inducers include artemisinin antimalarials, barbiturates, carbamazepine, cyclophosphamide, efavirenz, lopinavir, methimazole, nelfinavir, phenobarbital, phenytoin, primidone, rifampicin/rifampin, ritonavir, abacavir, amprenavir, nevirapine, telaprevir
8. Receipt of zidovudine, desipramine, or other drugs that may increase serum concentration when combined with methadone within 30 days prior to study enrollment
9. Known or suspected gastrointestinal obstruction, including paralytic ileus
10. Significant respiratory depression (respiratory rate less than 8 breaths/min or oxygen saturation (SpO2) \<95%)
11. BMI ≥ 33 and BMI ≤ 17
12. Known history of moderate-to-severe liver (Child Class B or C) or kidney disease (serum creatinine \> 1.5)
13. Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
14. Females who are pregnant or nursing
International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)

The study compares the short- and long-term risks of a 24-day regimen of a drospirenone-containing oral contraceptive with the risks of established oral contraceptives in a study population that is representative for the actual users of the individual preparations.

Drospirenone is a novel progestogen with antiandrogenic and antimineralocorticoid properties. A large active post-marketing surveillance study has demonstrated that a 21-day regimen of 3mg drospirenone and 30mcg ethinylestradiol can be used safely for oral contraception. This study investigates the risks of short and long-term use of a 24-day regimen of drospirenone/ethinylestradiol in comparison to established OCs in a study population that is representative of the actual users of the individual preparations.

INAS-OC is a prospective, controlled, non-interventional cohort study with two study arms: OCs containing drospirenone and OCs containing any other progestogen. The study was started in the USA in April 2005 and was extended to several European countries in September 2008 based on the launch status of the 24-day regimen. New users of an OC (starters, switchers without a pill intake break and recurrent users with a pill intake break \[same or different OC\]) are accrued by a network of prescribing physicians. Baseline and follow-up information are collected via a self-administered questionnaire. Data analysis will be based on life-table methods comparing the cohorts. All analyses will make allowance for confounding, using methods that will include multivariate techniques such as Cox regression.

Eligibility Criteria:
Inclusion Criteria:

* First-ever OC users ("starters")
* Women switching OC use without a pill intake break ("switchers")
* Recurrent users with a pill intake break ("recurrent users")
* Women willing to participate in the active surveillance

Exclusion Criteria:

* Women who do not agree to participate
* Long-term users
Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes

This trial is conducted in Europe and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Current treatment with basal-bolus insulin regimen for more than or equal to 3 months
* HbA1c less than or equal to 11.0%

Exclusion Criteria:

* Proliferative retinopathy or maculopathy
* Recurrent major hypoglycaemia
* Impaired hepatic or renal function
* Cardiac problems or uncontrolled hypertension
Acquisition of Portal Venous CTCs and Exosomes From Patients With Pancreatic Cancer by EUS

The investigators are going to explore the diagnostic and prognostic value of circulating tumor cells and exosomes extracted from the portal venous blood obtained with endoscopic ultrasound in pancreatic cancer patients.

As the prognosis of pancreatic cancer, a kind of malignant tumor, remains poor due to the low diagnostic rate at the early stage, there is still a significant clinical need to determine individualized tumor molecular profiles and personalized risk for recurrence. Circulating tumor cells (CTCs) and exosomes from patients with primary tumors may hold promise in serving as an informative biomarker to address this clinical need. Here in this study, the investigators are going to explore the feasibility and safety of sampling portal venous blood via endoscopic ultrasound (EUS), and detect portal venous CTCs and analyze mRNA markers of exosomes by RNA-seq. The investigators aim to explore the potential molecular mechanisms in tumor microenvironment and mechanisms of drug resistance.

Eligibility Criteria:
Inclusion Criteria:

1. Aged from 18 to 80 years-old
2. Suspected pancreatic masses and referred for EUS-FNA for pathology diagnosis
3. Written informed consent

Exclusion Criteria:

1. Patients who have received adjuvant chemotherapy and other anti-tumor treatments
2. Severe heart, lung, liver, kidney insufficiency, or severe bleeding disorders, severe coagulopathy or local/systemic infections, other critical illnesses
3. Women who are planning to become pregnant or are pregnant or breast-feeding
Trial to Evaluate Efficacy of Olanzapine With Short-acting 5HT3 Inhibitors in Chemotherapy-induced Nausea & Vomiting (CINV) Prophylaxis

Olanzapine-containing regimens for CINV prophylaxis may provide even better protection than aprepitant-containing regimens.

Olanzapine-containing regimens for CINV provide high complete response (CR) rate in patients receiving high emetogenic chemotherapy. Olanzapine may be more effective than aprepitant in this setting but cheaper. However, there is no strong evidence supporting the advantages of olanzapine over aprepitant - and this is the reason why aprepitant is still the standard of care. Due to high cost aprepitant can be not affordable in low- and middle income countries; this compromises quality of life of cancer patients. On the other hand, recommended olanzapine-based regimen includes palonosetron, whose price is quite high as well and undesired sedation is a common side effect for olanzapine doses that currently recommended, these adverse events precludes wide use of olanzapine in oncology. Development of effective, tolerable and affordable regimen for CINV prophylaxis based on low-dose olanzapine and short-acting 5-HT3 inhibitors can improve quality of care for many cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. High-emetogenic chemotherapy (HEC) regimen (e.g., cisplatin ≥70 mg/m2 or doxorubicin ≥60 mg/m2 or carboplatin AUC≥4). Patients that are prescribed less doses of mentioned agents are still allowed if another high-emetogenic drug will be administered (eg, doxorubicin plus cisplatin);
2. Administration of HEC component only in first day of the cycle;
3. No previous chemotherapy or radiotherapy;
4. No concomitant quinolone antibiotics administration;
5. ECOG PS ≤2;
6. No nausea and vomiting 24 hours before enrollment;
7. Adequate hepatic and renal function (eg, ALaT, ASaT ≤3 ULN, creatinine clearance ≥50 ml/minute).
8. No brain metastases, leptomeningeal carcinomatosis, and chronic diseases such as uncontrolled diabetes mellitus and chronic alcohol consumption.
9. Subject willing to participate in the trial and provided informed consent form.

Exclusion Criteria:

1. Previous chemotherapy or radiotherapy;
2. Moderate- or low- emetogenic chemotherapy;
3. Multiday administration of HEC agents;
4. ECOG PS \>2;
5. History of brain metastases, signs of symptoms of bowel obstruction;
6. Nausea and/or vomiting of any genesis 24 hours before enrollment;
7. Uncontrolled diabetes mellitus or other metabolic diseases; chronic alcohol consumption.
8. Diseases and conditions interfere with subject ability to swallow the drug and to take oral medication;
9. Concomitant therapy with olanzapine or other antipsychotic drugs; history of mental illness;
10. Concomitant therapy with quinolone antibiotics;
11. Contraindications for olanzapine or aprepitant administration;
12. Intraperitoneal or intrapleural administration of HEC drugs;
13. Inadequate hepatic and/or renal function.
Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Treatment-Resistant Keratitis

The purpose of this open, mono center trial is to assess the impact of the use of an amniotic membrane on the healing of a keratitis resistant to medical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male or female; age between 18 and 65 years.
* Patient with non-infectious keratitis resistant to medical treatment for more than 15 days or recurrent after healing treatment.
* Patient with quantitative and qualitative score for inflammatory ocular signs \> 20.
* Patient with Oxford grade \> 2.
* Informed and consenting patient with a relative or friend available to instill eye drops if necessary.
* Patient affiliated to a social security system or beneficiary of such a system.

Exclusion Criteria:

* Patient with active infectious keratitis (bacterial, parasitic or viral).
* Patient with allergy to Oxybuprocaine or Tetracaine eye drops, to ester type local anesthetics and to fluorescein.
* Current contact lens wear, including scleral lenses.
* NSAID eye drops and any drops containing preservatives.
* Antibiotic, anti-viral, anti-parasitic eye drops.
* Patient with identified causes for the keratitis for which discontinuation of medical treatment beneficial.
* Ocular surgery in the 3 months preceding the inclusion in the study.
* Monophtalmic patient.
* Person deprived of liberty by a judicial or administrative decision.
* Adult subjected to a legal protection measure or unable to express his/her consent.
A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 Diabetes Mellitus (T2DM) (Part A) and multiple doses of LY3938577 in participants with T2DM (Part B). The study will last approximately 6 weeks for Part A and approximately 10 weeks for Part B respectively.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are overtly healthy as determined by medical evaluation (Part A)
* Participants with T2DM diagnosed greater than 1 year before enrollment (Part A and Part B)
* Have a body mass index within the range of 18.5 to less than or equal to (\<=) 32 kilograms per square meter (kg/m²) for healthy participants and 18.5 to 40 kg/m² for T2DM participants.
* Male or female participants of nonchildbearing potential

Exclusion Criteria:

* Have proliferative retinopathy or maculopathy and/or severe neuropathy
* Have been treated with sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, glucagon-like peptide-1 receptor agonist or Insulin within the previous 3 months
* Have received chronic systemic glucocorticoid therapy in the past 3 months
* Are currently enrolled in another clinical study trial involving medical research, or have participated within the last 30 days in a clinical study involving an investigational product.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 14332 CL Powder in Healthy Male Subjects

To investigate safety, tolerability and pharmacokinetics, and pharmacodynamics of BI 14332 CL


Eligibility Criteria:
Inclusion Criteria:

* Healthy males were included based on a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, and clinical laboratory tests
* Age ≥18 and Age ≤50 years
* Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, HR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which reasonably influenced the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range and of clinical relevance
* Inability to comply with the dietary regimen of the study centre
* Any ECG value outside the reference range and of clinical relevance including, but not limited to QRS interval \>120 ms or a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms or QT \>500 ms)
* A history of additional risk factors for Torsades des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
* The use of concomitant medications that prolong the QT/QTc interval
QUILT-3.025: A Phase 2 Study of AMG 479 in Relapsed or Refractory Ewing's Family Tumor and Desmoplastic Small Round Cell Tumors

Single-arm, open-label study of AMG 479 in up to 35 subjects with Ewing's Family Tumors (EFTs) and Desmoplastic Small Round Cell Tumors (DSRCTs) who have progressed or recurred after at least one prior chemotherapy regimen. An exploratory cohort of an additional up to 10 subjects with prior exposure to anti-IGF-1R therapy and who have progressed or recurred after at least one prior chemotherapy regimen will also be assessed.


Eligibility Criteria:
Male and female subjects ≥ 16 years of age with a diagnosis of EFT or DSRCT who have relapsed or progressed after at least one prior chemotherapeutic regimen will be eligible for this study.

Before any study-specific procedure, the appropriate written informed consent must be obtained.

Inclusion Criteria:

Disease Related Subjects with pathological or histological diagnosis of Ewing's Family Tumor or Desmoplastic Small Round Cell Tumor.

* Measurable disease as defined by RECIST.
* Documented failure of at least one prior chemotherapy regimen for their disease.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.

Demographic

* Males or females ≥ 16 years old.
* Signed written informed consent.
* Able to comply with visits and procedures.

Laboratory

* Willing to provide existing and/or newly acquired tumor samples.
* Diabetic Subjects (Type 1 or 2) must have HgbA1c \< 8.0% and fasting blood glucose level \< 160 mg/dL.

General

* Must be willing and able to use birth control (double barrier protection or abstinence) during and for 6 months after the study
* Prior exposure to another anti-IGF-1R therapy will only be allowed for a limited number of additional subjects (up to 10) in an exploratory cohort

Exclusion Criteria

Disease Related

* Known brain metastasis.
* History of bleeding diathesis.
* History of another malignancy.
* History of chronic hepatitis.
* Documented prior history of human immunodeficiency virus.

Laboratory

* Absolute neutrophil count \< 1.5 x109/L.
* Platelet count \< 100 x 109/L.
* Hemoglobin \< 9 g/dL.
* PT \> 1.5 x institutional upper limit of normal (IULN) or PTT \> 1.0 x IULN.
* Serum creatinine \> 1.5 x IULN.
* Aspartate aminotransferase (AST) \> 2.5 x IULN or Alanine aminotransferase (ALT) \> 2.5 x IULN (\> 5.0 x if liver metastases present).
* Total bilirubin \> 1.5 IULN (\> 3.0 x with documented Gilbert's Syndrome)

Medication

* Antitumor treatment within 21 days of Study Day 1.
* Anticoagulation therapy within 28 days of Study Day 1.
* Major surgery within 28 days of Study Day 1.

General

* Other investigational procedures are excluded.
* Inability to tolerate intravenous administration.
* Subject is pregnant (eg, positive HCG test) or is breast feeding.
A Study to Assess the Interaction Between ASP1707 and Itraconazole in Healthy Female Subjects

The purpose of this study to explore the effect of multiple oral doses of itraconazole on the pharmacokinetics of a single oral dose of ASP1707 in healthy female subjects. This study will also evaluate the safety and tolerability of a single oral dose of ASP1707 alone and in combination with itraconazole.

Subjects will be confined in the clinical unit for up to 15 days.

Eligibility Criteria:
Inclusion Criteria:

* Female subject must be either of non child bearing potential, post-menopausal prior to screening, or documented surgically sterile. Or, if of childbearing potential, must agree not to try to become pregnant during the study and for 28 days after the final study drug administration, must have a negative urine pregnancy test at Day -1 and, if heterosexually active, agree to consistently use two forms of highly effective form of birth control starting at screening and throughout the study period and for 28 days after the final study drug administration.
* Female subject must not be breastfeeding at screening or during the study period, and for 28 days after the final study drug administration.
* Female subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.

Exclusion Criteria:

* Female subject who has been pregnant within 6 months prior to screening assessment or breast feeding within 3 months prior to screening.
* Subject uses grapefruit (more than 3x 200 mL) or marmalade (more than three times) in the week prior to admission to the Clinical Unit until ESV, as reported by the subject.
* Subject is a vulnerable subject (e.g., subject kept in detention).
Effects of Topical Anesthesia With Pressure Nebulized 2% Lidocaine During Awake Intubation

As reported, about 0.43% patients can not be intubated unevenly because of difficult airway and 30% of the total death of anesthesia due to failed intubation. The difficult airway will disturb the clinical treatment and even threaten the patients' life. But the present methods for tracheal intubation during awake intubation can not provided ideal intubation condition. In this study, the investigators will perform topical anesthesia with the nebulized 2% lidocaine at 10L/min oxygen flow rate, and the observer's assessment of alert and sedation (OAA/S) scale was controlled to 3-4 points by intravenous midazolam,propofol, and remifentanil. Tracheal intubation was performed after topical anesthesia. The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood samples were taken to measure stress factor during intubation period.Intubation condition score was assessed and the complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation. The investigators aim is to evaluate the effect of topical anesthesia with lidocaine nebulized by 10L/min oxygen flow rate during awake tracheal intubation.

90 adult patients for elective surgery under general anesthesia, aged 18-60 years old, Mallampti Ⅰ-Ⅱ class, , were randomly allocated to receive topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times(each group n=30). Before topical anesthesia, the observer's assessment of alert and sedation (OAA/S) scale was controlled to 3-4 points by intravenous midazolam (0.03mg/kg), propofol (2mg/kg/h) and remifentanil (0.05μg/kg/min). Ten minutes after sedation, topical anesthesia was performed with the nebulized 2% lidocaine at 10L/min oxygen flow rate, meantime patients were told to breathe deeply. Tracheal intubation was performed after topical anesthesia. The arterial pressure (MAP), heart rate (HR) and pulse oxygen saturation (SpO2) were recorded and blood samples were taken to measure the serum cortisol and insulin concentration during intubation period. Intubation condition score was assessed and the complications like local anesthetic toxicity, mucosa injury, respiration depress were also recorded. Patients were asked whether they could recall the events during intubation 24 hr after operation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18-60 years old with Mallampti Ⅰ-Ⅱ class

Exclusion Criteria:

* Patients who have allergic reaction to the drugs used during anesthesia
* Patients who have a history of gastro-esophageal regurgitation, or with full stomach
* Patients with abnormality of cardiopulmonary function, renal and liver function
* Patients with abnormality of endocrine function
* Patients with increased intracranial pressure or epilepsy