cyrilzakka/clinical-trials huggingface dataset:
A Study of JNJ-56136379 in Healthy Participants

The purpose of this study is to evaluate the effect of multiple-dose JNJ-56136379 on the single-dose pharmacokinetics (PK) of the combination of bictegravir (BIC), emtricitabine (FTC), tenofovir alafenamide (TAF) in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Healthy on the basis of clinical laboratory tests performed at screening. If the results of the blood biochemistry, blood coagulation, and hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* Women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and urine pregnancy test on Day -1
* Blood pressure (after the participant is supine for 5 minutes) between 90 and 140 millimeters of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic. If blood pressure is out of range, up to 2 repeated assessments are permitted
* Must have a normal 12-lead electrocardiogram (ECG) at screening, including: a) predominant sinus rhythm, b) heart rate between 45 and 100 beats per minute (bpm), extremes included, c) QT interval corrected for heart rate (QTc) interval less than or equal to (\<=) 450 milliseconds (ms) in male participants/ \<= 470 ms in female participants (QT interval corrected according to Fridericia \[QTcF\]), c) QRS interval of less than (\<)120 ms, and d) PR interval \<=220 ms

Exclusion Criteria:

* Having donated or lost 1 or more than 1 unit of blood (500 milliliter \[mL\]) or had any clinically significant abnormal bleeding in the prior 60 days before the planned first administration of a study drug
* Any history of clinically significant skin disease (as judged by the investigator) such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
* A history of clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
* Current human immunodeficiency virus (HIV)-1 or HIV-2 infection (confirmed by antibodies) at screening
* Clinically significant history of liver disease or renal dysfunction (estimated creatinine clearance \<60 milliliter per minute \[mL/min\]) at screening
Effect of Ziprasidone on Glucose & Plasma Lipids in Diabetes (II) and Schizophrenia or Schizoaffective Disorder

The aim of the protocol is to study the effects of 320 mg/day of ziprasidone (Geodon) on glucose and lipid metabolism of patients with both Diabetes Type II (DM) and schizophrenia or schizoaffective disorder, after switching their antipsychotic medication/s from typical and/or atypical to ziprasidone monotherapy.

Inpatients with DSM IV diagnosis of schizophrenia or schizoaffective disorder and DM II will be enrolled after giving informed consent. Participants may stay on their original ward at MPC, if their clinical care would be better served on their home ward because of patient programs and/or continuity of care reasons. Patients recruited from other participating sites will be transferred to MPC research ward.

There will be a screening phase (two weeks) on the prior antipsychotic regimen, a cross-titration phase (three week) and a ziprasidone phase (eight weeks; four time points).

All medications, except for the antipsychotic agents, will be kept stable throughout the protocol. These medications may include anticholinergics, mood stabilizers and antidepressants. After the screening phase lasting two weeks, patients will enter the cross-titration phase lasting three week. The cross titration schedule will be changed in accordance with Deutschman \& Deutschman's 2005 recommendations. The current antipsychotic will be gradually decreased to zero and ziprasidone will be started at 40 mg bid po and raised up to 160 mg po bid during the cross-titration phase, according to clinical response and tolerance. After the cross-titration phase has concluded, the ziprasidone dose will range from 80 mg bid p.o. to 160 mg bid p.o. daily according to clinical response during the eight week treatment phase.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 65 years
2. DSM IV diagnosis of schizophrenia (all subtypes) or schizoaffective disorder
3. Diabetes Mellitus type II treated with oral antidiabetic drugs or insulin
4. Stable dose of antipsychotic regimen for previous one month.
5. Stable dose of antidepressant regimen for previous one month.
6. Stable dose of adjunctive mood stabilizer and/or anticholinergic regimen for previous 1 month
7. Signed informed consent
8. Absence of significant cardiovascular pathology as demonstrated by EKG (QTc \< 450 millisec)
9. Absence of severe medical conditions (except for DM) requiring frequent changes in medication.

Exclusion Criteria:

1. DSM IV diagnosis other than Schizophrenia or Schizoaffective disorder
2. Unstable epilepsy
3. Acute, unstable or significant medical condition
4. Suicidal or physically violent behavioral episodes in the previous month
5. Current DSM IV diagnosis of substance or alcohol abuse with positive urine toxicology in the past two weeks.
6. Liver enzyme test values ≥ three times upper normal limit for AST, ALT, GGT, and Alkaline Phosphatase; ≥ two times upper limit for LDH.
A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

This multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (NMOSD) who completed open-label extension (OLE) period of studies BN40898 and BN40900. Participants will receive satralizumab as monotherapy or in combination with one of the following background immunosuppressive treatments: azathioprine (AZA), mycophenolate mofetil (MMF), or oral corticosteroids.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged less than 18 years at the time of informed consent for Study BN40898 can continue treatment with a combination of oral corticosteroids and either AZA or MMF
* Participated in Study BN40898 or Study BN40900 with satralizumab in NMOSD, are on ongoing satralizumab treatment and were anti-aquaporin-4 IgG antibody (AQP4-IgG) seropositive at screening in these studies. Participants with NMOSD who were AQP4-IgG seronegative at screening in Study BN40898 or Study BN40900 can be enrolled if the investigator considers the continued treatment with satralizumab to be beneficial for the participant
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 3 months after the final dose of satralizumab.

Exclusion Criteria:

* Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug. Women of childbearing potential must have a negative urine pregnancy test result on the baseline visit prior to initiation of study drug
* Evidence of any serious uncontrolled concomitant diseases that may preclude participation including nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency
* Known active infection that requires delaying the next satralizumab dose at the time of enrollment
* NMOSD relapse at the time of enrollment
* Laboratory abnormalities at the last assessment in Study BN40898 or Study BN40900 that preclude re-treatment with satralizumab
Sentinel Lymph Node Biopsy With Hybrid Technique in Breast Cancer

Sentinel lymph node (SLN) biopsy is the gold standard method to stage axilla in breast cancer. The aim of the study is to compare the efficiency of various methods to identify SLN is breast cancer patients.

Various markers has been used for SLN biopsy including isosulfan blue (patent blue), indocyanine green (ICG), radioisotope colloid (RAIC) and ultrasound (US) with several advantages and disadvantages. In this study investigators designed an algorithm using the combination of mapping with patent blue, ICG, RAIC and US to compare the accurate identification of SLN in breast cancer patients. The protocol is based on the hypothesis that identification rate of SLN is increased with multiple agents. Patent blue and ICG provides visual guidance. The combination of dyes with sonographic and RAIC method have the potential to prevent obstacles and ensure better outcomes as an identification strategy.

Patent blue provides visual identification of the SLN. ICG fluorescence can be detected percutaneously and by means of fluorescence imaging system in real time. RAI has several advantages, but disadvantages as well, like cost and invisibility. RAI can only be detected and confirmed by means of sound and numerical value through gamma probe. All breast cancer patients underwent axillary ultrasound before SLNB with different mapping combinations. The determination of abnormal axillary lymph node was followed by ultrasound-guided FNA cytology of these nodes. The sonographic abnormality criteria of the nodes were defined as; completely hypoechoic node, asymmetric focal hypoechoic node, cortical lobulation more than 3, cortical thickness \>2mm, totally spheric appearance, absence of fatty hilum and compromise of normal vascularity (hypervascularization from various poles). Patients with negative results of FNA would undergo SLNB. Lymphatic mapping was performed with abovementioned dyes and radioactive colloid. Before the incising for SLNB real time intraoperative US was performed and suspicious axillary lymph nodes were seen by ultrasound guidance. In the SLNB operation, radioactive or dyed nodes and sonographically suspicious nodes were removed and labeled separately for pathological examination.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary breast cancer by core needle, incisional or excisional biopsy
* cN0 patients
* In patients with abnormal axillary lymph nodes sonographically US-guided FNA cytology of these nodes were performed and FNA cytology negative patients planed to undergo SLNB with different mapping techniques.

Exclusion Criteria:

* Patients with neoadjuvant therapy
* Patients with pathological diagnosed ductal carcinoma in situ by excisional biopsy
* Patients with pathologically proven axillary disease
* Patients with T4d tumor
Dose-finding Study With Lu AA24530 in Major Depressive Disorder

The primary purpose of this study is to assess the efficacy in treating patients with Major Depressive Disorder of one or more doses of Lu AA24530 relative to placebo

According to the World Health Organisation, Major Depressive Disorder is the leading cause of disability and the 4th leading contributor to the global burden of disease. There are unmet medical needs in the treatment of depressive disorders in terms of insufficient effectiveness and unpleasant side-effects of current therapies. The overall prognosis of the disorder is positive for the majority of patients, but as many as 30% of patients will develop a chronic and treatment-resistant depression. In the study, patients with depression are treated for 6 weeks. Assessments of efficacy and safety are taking place every week for the first 4 weeks and again after 6 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Episode that has lasted at least 3 months
* Moderate to severe depression

Exclusion Criteria:

* Any current psychiatric disorder established as the principal diagnosis other than MDD as defined in the DSM-IV-TR and as assessed with the Mini-International Neuropsychiatric Interview (MINI)
* Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR
* Major Depressive Episode that has been unresponsive to two adequate courses of antidepressant treatment, each of at least 6 weeks duration
* Electroconvulsive therapy within 6 months prior to Baseline
* Ongoing formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study
* Clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance
* The patient is pregnant or breast-feeding
Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 4873 in Healthy Adult Human Subjects

This is a Phase 1, multiple dose, open-label pharmacokinetic study conducted in healthy adult male and female subjects.

Subjects will receive 3 oral doses of WCK 4873 administered once-daily starting on Day 1. Blood collection for determining plasma WCK 4873 concentrations will be conducted within 15 minutes prior to and at 1, 2, 3, 4, 6, 9, 12, and 24 hours after the first dose of WCK 4873. The 24 hours post-dose sample after the first dose will be collected prior to Day 2 dosing. Blood samples for determining plasma WCK 4873 concentrations will also be collected within 15 minutes prior to and at 1, 2, 3, 4, 6, 9, 12, 24 and 36 hours after the third dose. Each subject will undergo one standardized bronchoscopy with bronchoalveolar lavage (BAL) in the outpatient bronchoscopy suite at 3, 6, 9, 12, 24 or 48 hours after the third oral dose of WCK 4873. Subjects scheduled for bronchoscopy at 48 hours will also have blood sample drawn for determining plasma WCK 4873 concentrations at 48 hours after the third dose.

Safety will be assessed throughout the study by adverse event monitoring, clinical laboratory tests (including liver function tests), ECG, physical examination and vital sign monitoring. Subjects will discontinue study drug administration in the event of AST/ALT elevation of greater than 3 times the upper limit of normal.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 18.5 and 30 (kg/m2) and weight between 55.0 and 100.0 kg (both inclusive).
* Medical history without any major pathology as judged by the Principal Investigator.
* Resting supine blood pressure 100-139 (systolic) or 60-89 (diastolic) mm Hg, a resting pulse rate of 40 beats per minute or higher, and showing no clinically relevant deviations as judged by the Principal Investigator.

Exclusion Criteria:

* History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Positive alcohol breath test or urine drug screen test at screening or confinement.
* Positive testing for HIV, Hepatitis B or Hepatitis C.
* Clinically significant pulmonary or any other disease that prevents a subject from undergoing bronchoscopy with pulmonary lavage.
Mass Balance, Pharmacokinetics, and Metabolism of 14C-labeled ACT-128800 Administered to Healthy Male Subjects

The study was conducted to investigate the metabolism and mass balance of ACT-128800, and to identify the elimination pathways (metabolism and excretion) of ACT-128800 and compare them with the known metabolic profiles of ACT-128800 in animals.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Male and aged between 45 and 65 years (inclusive) at screening.
* No clinically significant findings on physical examination performed at screening.
* Body mass index (BMI) between 18-28 kg/m\^2 (inclusive) at screening.
* Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and heart rate 55-90 bpm (inclusive), measured on the leading arm, after 5 minutes in the supine position at screening. These criteria should also be met before the administration of the first dose.
* 12-lead electrocardiogram without clinically relevant abnormalities at screening.
* Clinical chemistry, hematology, and urinalysis results not deviating from the normal range to a clinically relevant extent at screening.
* Negative results from urine drug screen at screening.
* Ability to communicate well with the investigator in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

* Known hypersensitivity to any excipients of the drug formulation.
* Treatment with another investigational drug within the 3 months prior to screening.
* History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
* Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug.
* Smoking within the 3 months prior to screening.
* Any immunosuppressive treatment within 6 weeks before study drug administration.
* Previous treatment with any prescribed or over-the-counter medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
* Loss of 250 mL or more of blood within the 3 months prior to screening.
* Lymphopenia (\< 1,100 lymphocytes/μL).
* Viral, fungal, bacterial or protozoal infection within 4 weeks before study drug administration.
* Positive hepatitis B or hepatitis C serology, except for vaccinated subjects, at screening.
* Positive human immunodeficiency virus serology at screening.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* Legal incapacity or limited legal capacity at screening.
* Exposure to artificial ionizing radiation (e.g., X-ray, thyroid scan, study with radiolabeled compound) in the 12-month period before screening.
* A history of clinically relevant constipation (defined as lasting more than 3 days) in the 4-week period before screening.
Intranasal Insulin for Weight Management During Smoking Cessation

This FDA-approved (IND# 120700) study will evaluate efficacy of intranasal insulin in reducing snack intake and reducing postprandial free fatty acid levels in abstinent smokers.


Eligibility Criteria:
Inclusion Criteria:

* smokers (\>10 cig/day) for the past 1 year
* normosmic olfactory function

Exclusion Criteria:

* previous/current use of insulin
* current Diagnostic and Statistical Manual-IV-Revised (DSM-IV-R) Axis I disorder
* current pregnancy (or lactation)
* lifetime history of endocrine disease
* excessive alcohol use (\>25 standard units of alcohol/week)
* current use of illicit drugs
* current use of a smoking cessation aid (NRT, Chantix or Wellbutrin), or a psychotropic agent
* local infections, inflammation, structural abnormalities, or other nasal pathology
* current use of any medications administered intranasally, including intranasal steroids
The Use of Quantitative Pregnancy Test in Amniotic Fluid as a Diagnostic Tool for Rupture of Fetal Membranes

Two groups will be recruited. The first group are pregnant ladies that have unequivocal rupture of fetal membranes that is diagnosed by seeing the amniotic fluid leakage in the vagina. The second group are normal pregnant ladies without rupture of membranes. both groups will be tested by taking vaginal washing fluid. Quantitative and qualitative pregnancy tests will be measured in this fluid.

Beta subunit of human chorionic gonadotropin assay will be measured in the vaginal washing in two groups. The first group are pregnant women in the second or third trimester. These women have definite rupture of membranes diagnosed by visual leaking of the amniotic fluid from the cervix during speculum examination. The second group are pregnant women with intact membranes. Assessment of both the qualitative and quantitative beta subunit of human chorionic gonadotropin will be done

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women between 14 and 40 weeks gestation with history of gush of vaginal fluid
* Pregnant women between without history of gush of vaginal fluid

Exclusion Criteria:

* Presence of vaginal bleeding
* Presence of any obstetric emergency as cord prolapse
Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Gynecological Tumors.

Gynecological cancers involve several tumors of the female reproductive system. The five most common gynecological tumors are those of the uterine cervix, endometrium, ovary, vagina and vulva. Furthermore, although rarer, there is a further gynecological tumor, which is generated from the gestational trophoblast tissue.These pathologies represent an important burden for society since there are over nine hundred thousand cases in Europe.

Ultrasound examination is the investigation commonly used to monitor high-risk women.

Magnetic resonance imaging (MRI) is considered the most accurate imaging technique for presurgical staging of gynecological tumors. Computed tomography (CT), on the other hand, is not usually used for diagnosis, but is considered very useful for investigating possible distant metastases.Finally, integrated positron emission tomography (PET)/CT and PET/MRI methods are innovative molecular imaging techniques and represent a continually expanding field of research in the oncology setting, including gynecological malignancies.

The present study is of considerable clinical relevance as at our Institute it is possible to have a significant number of patients suffering from gynecological neoplastic pathologies that are studied using PET, thus allowing the identification and validation of innovative imaging biomarkers, with the use of both traditional imaging parameters and radiomic features.


Eligibility Criteria:
Inclusion Criteria:

* adult patients suffering from a gynecological oncological disease; Patients who have performed at least one PET study with 18F FDG for the staging or restaging of their oncological pathology; patients who give written informed consent to the study

Exclusion Criteria:

* patients \<18 years lack of availability of clinical and PET imaging data useful for analyses.