cyrilzakka/clinical-trials huggingface dataset:
A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc

Healthy volunteers are being recruited for this pharmacokinetics study. The objective is to characterize the pharmacokinetic properties of maraviroc alone and when administered with rifabutin and to assess rifabutin and 25-O-desacetyl-rifabutin pharmacokinetics compared to the literature.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to sign informed consent prior to any study-related activities.
* Male or female participants between 18 and 65 years of age inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Healthy, i.e. not suffering from an acute or chronic illness and not using medications.
* Acceptable medical history, physical examination, and 12-lead ECG at screening.
* Acceptable laboratory values that indicate adequate baseline organ function at screening visit.
* Willing to stop using any herbal or natural health products for 2 weeks prior to and during the study including: Grapefruit, grapefruit juice, St. John's Wort.
* Willingness to abstain from alcohol use for 3 days prior to and during the study.
* Participant must practice a reliable method of birth control while they are participating in the study; for instance an intrauterine device (IUD), condom with spermicidal gel or foam, diaphragm with spermicidal gel or foam, vasectomy, tubal ligation, hysterectomy or abstinence or female must be post menopausal for at least one year.

Exclusion Criteria:

* Have serological evidence of exposure to HIV
* Female patients of childbearing potential who has a positive urine pregnancy test at screening
* Participants not willing to use a reliable method of barrier contraception during the study.
* Is breastfeeding.
* Inability to adhere to protocol.
* Use of any medications (2 weeks prior to or during the study) other than occasional use of acetaminophen.
* Participants taking oral contraceptive medications.
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* Patients may be excluded from the study for other reasons, at the investigator's discretion.
Innovative Device for Intravenous Administration

The prevention of catheter-related complications is nowadays an important topic of research. Flushing the catheters is considered an important clinical procedure in preventing malfunction and several complications such as phlebitis or infection. Considering the latest guidelines of the Infusion Nurses Society, the flushing involves a pre and post-drug administration, requiring different syringes (with associated overall increased times of preparation/administration of intravenous medication by nurses, also increasing the need for manipulation of the venous catheter).

A multi-centre, two-arm randomised controlled trial with partially blinded outcome assessment, of 146 adult patients. After eligibility analysis and informed consent, participants will receive usual intravenous administration of drugs with subsequent flushing procedures, with the double-chamber syringe (arm A) or with the classical syringes (arm B). The outcomes assessment will be performed on a daily basis by the unblind research team, with the same procedures in both groups. Some main outcomes, such as phlebitis and infiltration, will also be evaluated by nurses from a blind research team and registered once a day.


Eligibility Criteria:
Inclusion Criteria:

* Patients with 18 years or above, admitted to the orthopaedic department;
* Patients with the ability to fully communicate in Portuguese;
* Patients able to consent;
* Prescribed PIVC for intravenous therapeutic administration;
* PIVC expected to remain for at least 24 hours;
* PIVC inserted at the orthopaedic department;
* PIVC size 18 gauge (G) or 20 G;
* Anatomical insertion site in arm, forearm, or back of the hand;
* PIVC secured with a transparent, semi-permeable polyurethane film dressing.

Exclusion Criteria:

* - Patients with a known infectious disease;
* Patients with leucocytosis, defined as ≥1200 leukocytes/mm3;
* Patients with anaemia, with haemoglobin levels \<13g/dl for men, and \<12g/dl for women;
* Patients receiving immunosuppressive treatment within 6 months prior to hospital admission;
* Patients receiving chemotherapy or radiotherapy within 6 months prior to hospital admission;
* Patients with body mass index below 16 kg/m2 or above 39 kg/m2;
* Anatomical insertion site in flexion areas (e.g. cubital fossa region) or lower members;
* Skin lesions at the insertion site (e.g. previous infiltration, dermatitis, burns) and skin alterations such as tattoos;
* Peripheral venous alterations resulting from previous hospital admissions.
3D Cine Cardiovascular Magnetic Resonance

Conventional CMR is based on breath-hold 2D cine image acquisitions which are sequentially acquired in different imaging planes. The necessity of precisely planning and then acquiring multiple 2D imaging planes during breath-hold is relatively inefficient and leads to CMR exam times of ≤60 minutes. However, some patients are too ill or young to hold their breath. Furthermore, 2D images sometimes fail to provide a complete picture of complex 3D anatomy of patients with complex morphology.

To address these limitations, we have recently developed a 3D cine (3 spatial dimensions plus time) CMR technique. Rather than acquiring 2D cine images in multiple orientations during breath-hold, this approach allows one to acquire a free-breathing 3D block of data for each phase of cardiac cycle that can be reformatted offline into the desired views without adding to the exam time. This added efficiency should lead to a reduction in CMR exam time, increasing patient comfort, and making CMR exam easy and available for all. In addition, the 3D nature of the data may yield more complete information about the anatomy and physiology.

In this proposal, we will examine the agreement between the 2D cine and 3D cine CMR techniques with regard to left and right ventricular volumes and systemic and pulmonary blood flow circulation. The internal consistency of the measurements between the 2 techniques will be also investigated. This study will focus on children because they may benefit the most from the short, improved efficiency, and free-breathing CMR exams.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are greater than 40 kg and are referred for a clinically indicated 2D CMR exam with a gadolinium-based contrast agent. Informed consent/assent will be obtained.

Exclusion Criteria:

* Patients who are under anesthesia, sedated, or with a contraindication to CMR exams.
Awareness Of Gynecologists About Role Of Physical Therapy In Management Of Polycystic Ovarian Syndrome

This study aimed to measure the extent of knowledge of gynecologists about the role of physical therapy in the management of PCOS.

Physical therapists are good communicators and also have the knowledge and skills to make a substantial impact in this field of management of polycystic ovarian syndrome.

It is important for the gynecologists to have awareness about the role of physical therapy in polycystic ovarian syndrome to encourage patient to seek physical therapy help instead of suffering in silence and improve their quality of life

Eligibility Criteria:
Inclusion Criteria:

* Gynecologists with more than 2 years' experience.
* Had managed cases of PCOS.

Exclusion Criteria:

* Gynecologists with less than 2 years' experience.
* Gynecologists who didn't deal with PCOS.
Prebiotics as a Means to Modulate Gut Fermentation, Metabolism, Appetite and Cognition

This study aims at investigating the impact of colonic fermentation of intrinsic indigestible carbohydrates in cereal whole kernels after three days consumption, on metabolic variables and cognition. The study is performed in healthy, normal to slightly over-weight test subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI 19-28 kg/m2

Exclusion Criteria:

* gastrointestinal diseases
* metabolic disorders
* tobacco/snuff user
* antibiotic/probiotic treatment
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 443139 in Participants With Early Manifest Huntington's Disease

This study tested the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of ISIS 443139 administered intrathecally to adult participants with early manifest Huntington's Disease.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with early manifest Huntington's disease
* Male or female, aged 25 to 65 years, inclusive, at the time of informed consent
* Able and willing to meet all study requirements, including travel to Study Center and participation in all procedures and measurements at study visits
* Have a trial partner who is reliable, competent and at least 18 years of age, is willing to accompany the participant to select trial visits and to be available to the Study Center by phone if needed
* Able to tolerate MRI scans, blood draws and lumbar punctures
* Reside within 4 hours travel of the Study Center

Key Exclusion Criteria:

* Clinically significant medical condition, such as severe chorea, active suicidal ideation or any other conditions which would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study
* Recent treatment with another investigational drug, biological agent, or device
* Prior treatment with an antisense oligonucleotide \[including small interfering ribonucleic acid (siRNA)\]
* Any history of gene therapy or cell transplantation or any other experimental brain surgery
* Presence of an implanted shunt for the drainage of cerebrospinal fluid (CSF) or an implanted central nervous system (CNS) catheter
* History of post-lumbar-puncture headache of moderate or severe intensity and/or blood patch
* Malignancy within 5 years of Screening, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated
* Hospitalization for any major medical or surgical procedure involving general anesthesia within 12 weeks of Screening or planned during the study
Phase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

The primary purpose of the study is to determine the impact of chemotherapy on the ability of your surgeon to completely remove the cancer as well as the impact on your survival. Furthermore the investigators will be assessing the side effects of this chemotherapy strategy. Finally the investigators will determine the ability of specialized imaging technology (PET scan) to document and predict the response of the tumor to this chemotherapy.

Standard therapy for patients with your condition usually consists of surgery (removal of the tumor) followed by combination chemotherapy and radiotherapy. More recently, standard options available to patients with cancer of the stomach or lower esophagus have been expanded to include chemotherapy without radiotherapy prior to and following surgery. While it is believed that chemotherapy prior to surgery is a good option for patients with stomach, it is not known what is the optimal chemotherapy regimen to offer patients prior to surgery to improve the likelihood of cure while limiting side-effects to patients.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of adenocarcinoma of the stomach, gastroesophageal junction (GEJ), or lower third of the esophagus.
* The tumour must be deemed by the team to be potentially resectable. This includes imaging studies (detailed below) to clinically stage the tumour and rule-out the presence of metastatic disease, and includes a preoperative laparoscopic evaluation.
* Stage IB (T1N1 only), II, IIIA, IIIB, and IV (T4N1 only)
* Life expectancy greater than 3 months
* ECOG performance status of 1 or better (i.e. restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work).
* Adequate hematologic reserve: Platelet count 100,000/L, WBC 2000/μL
* Creatinine clearance 60 ml/min, AST \& ALT 2 ULN, Alkaline phosphatase 2.5 ULN, bilirubin ULN

Exclusion Criteria:

* Prior systemic therapy for gastric cancer
* Prior docetaxel-containing chemotherapy
* Pre-existing medical conditions precluding treatment, including any contraindication for major surgery
* Pregnancy or lactating mothers. Women of childbearing age must use contraception during and for 3 months following treatment.
* Unable to give informed consent
* Patients that are not able to maintain nutrition by oral consumption of food alone must have additional enteral feeding.
* Patients with macroscopic disease noted at laparoscopy
* ECOG performance status of 2 or higher
* Significant hearing impairment, as judged by the need for or use of a hearing aid. If there is any uncertainty regarding the degree of hearing impairment, an audiogram will be done. If the audiogram is grossly normal or shows only minor hearing impairment (i.e. not requiring hearing aid), the patient may be enrolled.
* Unwillingness to undergo investigations and/or treatment as outlined on the study
Meglimine Sodium Succinate for Correction of Metabolic Acidosis in Critically Ill Patients

An acid-base imbalance, called metabolic acidosis (acid-base disorder lasting from several minutes to several days, caused by a decrease in serum bicarbonate ion (HCO3) concentration), is often observed in critically ill patients with various underlying diseases. Metabolic acidosis has a negative impact on the cardiovascular, respiratory, digestive, nervous, excretory, hematological, endocrine, musculoskeletal and immune systems and is associated with unfavourable outcomes. Reamberin® is a solution of disubstituted sodium salt of succinic acid, which has an alkaline reaction and succinate is capable to integrate into the Krebs cycle and restore energy metabolism in the cell. The aim of the present study is to evaluate the efficacy and safety of meglumine sodium succinate at a dose of 500 to 3000 ml in critically ill patients with metabolic acidosis and choose the optimal volume of its solution for the correction of metabolic acidosis in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated written Informed Consent (if unconscious due to a critical condition, the decision is made by a Council consisting of 3 physicians)
2. Male and female patients aged 18-70
3. Critical illness ((shock (including traumatic, hypovolemic), major trauma, acute massive blood loss, acute complicated surgical diseases of the abdominal organs) accompanied by metabolic acidosis, defined as serum bicarbonate \<22mmol/L
4. pH of arterial blood 7.20-7.35, inclusive
5. Planned volume of infusion \>= 1500 ml per day
6. Interval between admission to the ICU and randomization \<24 hours

Exclusion Criteria:

1. Pregnant and lactating women
2. Known hypersensitivity to any component of the study drug / placebo
3. Chronic kidney disease stage C5 (end-stage renal failure)
4. Acute hepatic failure (ALT \> 15 upper normal limits) or liver cirrhosis
5. Traumatic brain injury accompanied by cerebral edema
6. Previously diagnosed mental illness
7. Any chronic disease in the terminal stage with a life expectancy of \< 3 months
8. HIV infection
9. Clinically significant cardiovascular disease (unstable angina pectoris or angina pectoris of functional class III or higher; chronic heart failure III - IV class according to NYHA; acute myocardial infarction within 6 months before screening)
10. Extremely low or extremely high body fat
11. Infusion sodium bicarbonate, sodium bicarbonate, trometamol, Sterofundin, Quintasol, Ringer's lactate (Hartmann's solution) within 6 hours before screening
12. Acute respiratory acidosis
13. Poisoning with chemical compounds causing metabolic acidosis
14. Alcohol in saliva at screening \>= 0.5 pro mille
15. Previously diagnosed chronic obstructive pulmonary disease
The Safety and Efficacy of Topical IDP-108 Versus Vehicle in Patients With Onychomycosis

The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed onychomycosis of the target nail
* Presence of mild to moderate onychomycosis, defined as 20 - 50% of the area of the target nail being clinically affected
* Has a positive KOH examination from the target nail
* Has a positive dermatophyte culture from the target nail

Exclusion Criteria:

* Presence of any disease or condition that might cause nail abnormalities or may interfere with the evaluation of the study drug
* Use of any systemic antifungal therapy within 4 weeks prior to the Screening visit or non-responsive to systemic antifungal therapy for onychomycosis
* Use of any prescription or over-the-counter topical antifungal therapy for the toenails within 4 weeks prior to the Screening visit
* Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
A Study of the Safety and Efficacy of A-60444 in Adults With Respiratory Syncytial Virus (RSV) Infection Following HSCT

Objectives

Primary Objectives:

* Pilot Study: A preliminary assessment of the exposure and safety of oral A-60444 in post-stem cell transplant patients with RSV infection.
* Main Study: To determine the antiviral effect of oral A-60444 versus placebo in post-stem cell transplant patients with RSV infection and to assess the safety of oral A-60444 in post-stem cell transplant patients with RSV infection.

Secondary Objectives:

* To study the pharmacokinetics of A-60444 in the presence of concomitant medications such as immunosuppressants and antifungals, in post-stem cell transplant patients with RSV infection.

Sample Size: Six patients will be included in the open, pilot phase of the study and there is an option to include a further 22 patients into the main, placebo-controlled study, depending on the pilot study findings. An independent Data Safety Monitoring Board will assess the findings of the pilot study.

Clinical will be recorded daily. A-60444 PK will be studied pre-dose and at peak dose on the last day (Day 5) of dosing.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with RSV infection who have had a stem cell transplant.
2. Female patients must be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant. Females of non-childbearing potential are defined as women who have had a hysterectomy, bilateral oophorectomy, tubal ligation, or who have been post-menopausal for at least two years; or are considered to be sterile due to recent chemotherapy.
3. Aged between 18 and 65 years.
4. Patients who have given their written informed consent to participate in the study.
5. Patients who are willing and able to comply with the protocol and study procedures.

Exclusion Criteria:

1. Patients who have received an investigational drug within one month preceding the start of dosing.
2. Patients who have a documented history of allergy to benzodiazepines.
3. Patients with significant hepatic impairment (alanine transaminase \[ALT\] more than 5 x upper level of normal \[ULN\], total bilirubin more than 3 x ULN). Biochemistry data collected four weeks prior to screening is acceptable.
4. Patients, who in the opinion of their general practitioner or the Investigator, should not participate in the study.
Antithrombotics' Therapeutic Optimization in Hospitalized Patients Using Physiologically- and Population-based Pharmacokinetic Modeling

The main goal of the OptimAT study main goal is to validate a PBPK model for 3 direct oral anticoagulants (rivaroxaban, apixaban, dabigatran) and 3 P2Y12 inhibitors (clopidogrel, ticagrelor, prasugrel) in hospitalized patients.

Patients treated with antithrombotics are at risk of both severe ischemic and bleeding events. However, current clinical scores are insufficiently discriminant to predict the most favorable drug and dosing for an improved net clinical benefit. Physiologically and population-based pharmacokinetic models (PBPK and POPPK respectively) incorporate substrate specific properties obtained from experimental in-vitro experiments as well as patients' demographic, genetic and physiological in vivo data in order to characterize the dose-concentration relationships. As such, they can be used to simulate and predict PK profiles accounting for specific patients' characteristics and are the basis of dosing optimization. These models could be a valuable tool to predict antithrombotic blood concentration in a given patient. Our main goal is to elaborate predictive models characterizing the dose-concentration relationship with influencing variables of three direct oral anticoagulants (DOAC) (rivaroxaban, apixaban, dabigatran) and three P2Y12 inhibitors (clopidogrel, prasugrel, ticagrelor) in hospitalized patients, which will serve as basis for drug selection and dosage optimization.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients at any of the Geneva University Hospitals 18 yo and older
* Treated with DOAC (dabigatran, rivaroxaban, apixaban) or/and P2Y12 (clopidogrel, ticragrelor et prasugel) at the time of study blood sampling
* Understanding of French language and able to give an inform consent.

Exclusion Criteria:

* Patients with a reduced life span (\<6 mois)
* Exclusion criteria during follow up
* Change in dosage or cessation of the DOAC or P2Y12 taken by the participant follow up data will be censored at the time of change.