cyrilzakka/clinical-trials huggingface dataset:
PK and Bioavailability Comparison of Tofacitinib Between a Modified Release and The Immediate Release Formulation

A study to characterize the single-dose and steady-state pharmacokinetics of tofacitinib Modified Release (MR) formulation as well as to compare the extent of absorption of the MR 11 mg formulation (once daily) to that of the Immediate Release (IR) 5 mg formulation (twice daily) of tofacitinib in Chinese healthy subjects under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be of Chinese ethnicity (individuals currently residing in mainland China who were born in China and have both parents of Chinese descent).
* Healthy male and/or female subjects of non-childbearing potential
* Female subjects of non-childbearing potential must meet at least one of the following criteria:
* Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal state;
* Have undergone a documented hysterectomy and/or bilateral oophorectomy;
* Have medically confirmed ovarian failure.
* Body Mass Index (BMI) of 19.0 to 26.0 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Clinically significant infections within the past 3 months prior to first dosing (eg, those requiring hospitalization or parenteral antibiotics, or as judged by the Investigator), evidence of any infection within the past 7 days prior to first dosing, history of disseminated herpes simplex infection or recurrent (\>1 episode) or disseminated herpes zoster.
* Any condition possibly affecting drug absorption (eg, gastrectomy, colon resection, etc.).
* Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg, phenytoin, carbamazepine, rifampin) within 14 days or 5 half lives (whichever is longer) prior to dosing.
Effects of Omega 3 in Hemodialysis Patients

The aim of the study was to determine the effects of a 3-week fish oil oral supplementation on the metabolic fate and thermogenic effect of an oral glucose load in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* hemodialysis at least 6 months duration end stage renal disease

Exclusion Criteria:

* - Age \< 18 y ou \> 75 y
* Hemodialysis \< 6 months
* Diabetes, obesity
* allergy to fish
* Asthma
* glucocorticoïds, propranolol,, Immunosuppressive drugs, Insulin, Somatostatin
* erythropoïetin \< 3 months
* Cancer
* Hemoglobin \< 11 g/l
* disease \< 1 month
* pregnancy
* respiratory insufficiency
* intensive sport practice
* refusal
Study of NanoDOX Hydrogel vs Placebo for Dehisced Surgical Wounds

The purpose of this study is to determine the effects of NanoDOX Hydrogel versus Placebo Hydrogel on Dehisced Surgical Wounds.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or older
* Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline, and:
* Agree to use a double-barrier method of contraception during their participation in this study;

  * condoms (with spermicide) and hormonal contraceptives OR
  * condoms (with spermicide) and intrauterine device OR
  * intrauterine device and hormonal contraceptives OR
  * Abstains from sexual intercourse during their participation in this study OR
  * Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant
* Have a full-thickness dehisced surgical wound that is between 1.2cm2 and 4 cm2 at initial screening
* Be able to apply study drug to their wound, or have a reliable and capable caregiver do it
* Subjects will have adequate blood flow to the wound as defined by transcutaneous oxygen tension (TcpO2) of \>30mmHg recorded over intact epidermis at the dehisced surgical wound margin
* Non-infected (Quantitative bacterial count of \< 1.0 x 105 cfu)

Exclusion Criteria:

* Less than 18 years of age
* Pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control
* Allergic to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative
* Tested positive for a doxycycline-resistant infection
* Have undergone treatment with system corticosteroid or immunosuppressive therapy in the past 2 months
* Currently undergoing dialysis for renal failure
* Have participated in another clinical research trial within the last 30 days
* Subject has wounds resulting from any cause other than surgical intervention (diabetes, electrical burn, arterial insufficiency, chemical or radiation insult)
* Active or previous (within 60 days prior to the study screening visit) chemotherapy
* Active or previous (within 60 days prior to the study screening visit) radiation to the affected wound area to be treated by investigational drug or placebo
* Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits
* The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements standard-of-care self-care requirements, and all study-related follow up visit requirements
* History of sickle cell anemia
* History of infection with Human Immunodeficiency Virus
* History of other immunodeficiency disorders
* Severe anemia - Hgb \< 10 g/dL (males) or \< 9 g/dL (females)
* Severe malnutrition (Albumin \< 3.0 gm/dl; \> 10% weight loss in preceding 6 weeks)
* Subjects that the Investigators deems unstable and/or require intensive monitoring
Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Pyrazinamide Plus Allopurinol in Healthy Volunteers

The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of pyrazinamide in combination with allopurinol. Pharmacokinetics (PK) and whole blood bactericidal activity (WBA) will be measured in healthy volunteers following administration of pyrazinamide alone and in combination with allopurinol.

The whole blood bactericidal activity (WBA) assay is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial sterilisation. If performed in parallel with PK measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. The aim of this trial is to assess the WBA activity and PK data of pyrazinamide and its metabolites boosted with allopurinol in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 21 and 70 years old
2. Male or female willing to comply with the study visits and procedures
3. Willing and able to provide written informed consent

Exclusion Criteria:

1. Women who are currently pregnant or breastfeeding
2. Body weight 50kg or below
3. HLA-B\*5801 allele positive
4. Clinical evidence (symptoms and/or signs) suggestive of active TB
5. Previous hypersensitivity, intolerance or allergy to pyrazinamide or allopurinol
6. Current use of any drugs or medication known to have an interaction with pyrazinamide or allopurinol, or known to have anti-TB activity
7. Evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations
8. Known hepatic disease (including chronic hepatitis), recent hepatitis (within last 6 months) or alcohol abuse
9. Known hyperuricaemia or evidence of hyperuricaemia at screening
10. History or current episode of gout
11. Any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial
12. Current participation in other clinical intervention trial or research protocol
A Study to Evaluate Safety and Efficacy of TTP054 for 12 Weeks in Subjects With Type 2 Diabetes

The purpose of this study is to compare the safety and effect of TTP054 versus placebo on glucose control in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus
* On a stable (for the last 3 months) regimen of either metformin alone or metformin in combination with one additional acceptable oral antidiabetic (OAD) agent
* HbA1c: Metformin only: 7.0 - 11.0%; Metformin + acceptable OAD agent: 6.5 - 9.5%

Exclusion Criteria:

* History or evidence of significant diabetic complications
* History of heart attack, stroke or congestive heart failure
* Severe, uncontrolled hypertension
* Frequent hypoglycemia
* Women of child-bearing potential
IUdR/BUdR Cell Cycle Labelling

To determine cell cycle parameters and changes after treatment, the labelling agent is given and a bone marrow aspiration is accomplished before treatment and after treatment for comparison. Participants must be undergoing concurrent therapy for hematologic malignancy.

Cell cycle parameters include LI, Ts, Tc, T dpot, changes in these parameters, and differences between normal and leukemic cells in patients with hematologic malignancy prior to and following treatment.

Eligibility Criteria:
Histologic proof of one of:

* AML, ALL, or AUL
* MDS or CMML
* CML
* OR undergoing bone marrow transplantation.

Participants should be:

* off therapy for at least two weeks
* At least 18 years old or older
* Using adequate contraception if of child-bearing capability.
tES Effects on Associative Memory Performance

Previous studies showed that transcranial electric stimulation (tES) applied over the prefrontal cortex improves cognitive performance in healthy elderly adults as well as in patients suffering from mild cognitive impairment or early Alzheimer's disease. Therefore, tES methods might be a useful intervention tool for patients suffering from memory impairment in early terms of the disease.

The present study aims at establishing a connection between the stimulation-induced changes on associative memory performance and its underlying neurophysiological parameters. tES effects and their underlying mechanisms will be compared between healthy elderly controls and clinical study populations receiving either real or sham tES over the left ventrolateral prefrontal cortex during an associative memory task.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Non-smokers
* Right-handedness
* Native German speakers or comparable level of fluency
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Neurological or psychiatric condition (other than diagnosed cognitive impairment)
* Past head injuries
* Magnetizable implants
* History of seizures
* Current or life-time alcohol or drug abuse
* Skin diseases
ENRED@TE. Social Support in Southern Spain. Interventional Study

The main objective to be achieved is to find out if the perceived social support, the perceived loneliness, the perceived social isolation and the family support of those over 65 years of age improve after participating in the Enréd@te project carried out by the Spanish Red Cross (CRE).


Eligibility Criteria:
Inclusion Criteria:

* People over 65 years
* Not institutionalised

Exclusion Criteria:

* Participants of other programs
* Difficulty responding to measurement scales due to language barriers
* Legal incapacitation
* People with a residence of less than 3 months in the city
Correlation Between Changes in End-Tidal Carbon Dioxide and Stroke Volume Variation Detected by Electrical Cardiometry as A Predictor of Fluid Volume Responsiveness in Hemodynamically Unstable Patients in the Intensive Care

This study will be conducted to assess the role of end-tidal carbon dioxide (PETCO2) monitoring to predict the fluid volume responsiveness in correlation with stroke volume variation detected by electrical cardiometry in patients with hemodynamic instability.


Eligibility Criteria:
Inclusion criteria:

* Patients who will be 18 years or older.
* Patients on mechanical ventilation in the intensive care.
* Patients developing hypotension (MABP) \<65 mmHg.

Exclusion Criteria:

* Patients with organ/s failure at presentation.
* Patients with deep venous thrombosis.
* Patients with limb and pelvic fractures.
* Pregnant patients
Postoperative Sore Throat in Children: Comparison Between Two Supraglottic Devices, Ambu® AuraOnce™ Laryngeal Mask Airway (LMA) and I-Gel®.

Sore throat is minor but well recognized complaint after receiving general anaesthesia. It is rated as 8th most undesirable outcome in postoperative period.It not only affects the patient's satisfaction but also can affect patient activities after leaving hospital.

Many factors can contribute to postoperative sore throat and the incidence has been found to vary with the method by which airway is managed.

The study is conducted to compare the severity and frequency of postoperative sore throat in children undergoing elective surgery following the use of AmbuAuraOnce LMA and I-Gel. The study will be done in children who are able to self-report the severity of sore throat.

This study will help us to determine which supraglottic device (I-gel vs. AmbuAuraOnce LMA) is better in terms of causing less complication spells of sore throat. The use of such device will not only reduce the severity and frequency of postoperative sore throat that may affect the activities of patient after leaving hospital but also will improve satisfaction level of patient and parents.

OBJECTIVE:

The objective of our study is to assess the frequency and severity of postoperative sore throat by comparison between two supraglottic devices, AuraOnce Laryngeal Mask Airway (LMA) and I-gel in children undergoing elective lower abdominal or orthopedic surgery.

HYPOTHESIS: Use of I-gel in children undergoing elective lower abdominal or orthopedic surgery is associated with decrease frequency and severity of postoperative sore throat as compared to use of AuraOnce Laryngeal Mask Airway.

Eligibility Criteria:
Inclusion Criteria:

* 6 to 16 year old patients of both gender
* ASA (American Society of Anesthesiologists) I and ASA II patients
* Scheduled for elective lower abdominal surgery (inguinal hernia repair or circumcision) or orthopedic surgery (upper and lower limb) under General anesthesia.

Exclusion Criteria:

* Patients with risk of aspiration (incomplete NPO (Nil per oral), Gastroesophageal reflux disease, Congenital anatomic abnormalities of aero digestive tract, delayed gastric emptying, altered mental status)
* Difficult airway(difficult mask ventilation or difficult laryngoscopy, Cormack-Lehane grade more than 2 in patient history, trismus, limited mouth opening, trauma or mass)
* Children who are unable to self-report pain using a four-point categorical pain scale
* Refusal of the parent
* Refusal of the child to give assent
* Patients having pre-existing sore throat or symptoms of Upper respiratory tract infection.
* Obese children i.e. BMI for age percentile equal to or greater than the 95th percentile on BMI-for-age percentile growth charts.
Self-Perceived in Medical Students Undergoing Distance Learning

Our primary objective is identifying the degree of self-perceived competence in medical students without clinical rotations during the COVID-19 pandemic to know how prepared the students could be when they are professionals because they lack clinical skills in front of an actual patient and can be affected to be accepted in hospitals because they will have to acquire a phase of training later. Without a clinical rotation, one can be deprived of the essential educational value.The study design is an observational cross-section study in which an anonymous survey will be shared online on Google Forms platform. Students will be asked for their participation; after obtaining verbal and consent, the survey will be distributed using social media groups such as foundation school groups. For this study, the Spanish version of the Self-Perceived Competence scale will be used (REF). This scale is comprised of 21 questions divided into five factors that assess: 1) demonstration of the essential clinical skills, 2) demonstration of clinical reasoning, decision making, and problem-solving skills, 3) management of life-threatening medical conditions, 4) management of common medical problems and 5) placing patients' needs and safety at the center of the care process. Each item has a Likert scale answers of 4 options ranging from "incompetent (1)", "somewhat incompetent (2)", "somewhat.


Eligibility Criteria:
Inclusion Criteria:

* Medical students currently attending college in a distance learning modality.
* \> 18 years

Exclusion Criteria:

* Medical professionals and specialists
* university students
* \< 18 years
* Medical students currently attending clinical rotations
A Multicenter Research on the Effects of Substitution of Hospital Ward Care From Medical Doctors to Physician Assistants

Reallocation of healthcare is one solution to the problems healthcare is facing. In the Netherlands reallocation of care to Physician Assistants (PAs) hasn't adequately been studied. Given the growing number of PAs, it is essential to evaluate the effectiveness and efficacy of (Dutch) PA services.

This multicenter matched-controlled study aims to evaluate the (cost) effectiveness of substitution of hospital ward care from medical doctors (MDs) to PAs. The traditional model in which the role of house officer is taken by medical doctors MD model) will be compared with a mixed model in which a PA functions as house officer together with a medical doctor (PA/MD model). Hospital wards will be matched on medical specialism and hospital type (i.e. academic;non-academic). On the basis of USA studies, it is hypothesized that the mixed PA/MD model compared to the MD model reduces the costs of healthcare, while improving or maintaining the clinical outcomes, patients and provider satisfaction, and continuity and quality of care.

Primary research question:

• What is the effect of 'mixed PA/MD model' compared with 'MD model' on efficiency of care?

Secondary research questions:

* What is the effect of 'mixed PA/MD model' compared with 'MD model' on clinical and patients outcomes?
* What is the effect of 'mixed PA/MD model' compared with 'MD model' on continuity of care?
* What is the effect of 'mixed PA/MD model' compared with 'MD model' on nurses and (specialist) medicals doctor experiences?
* What are the barriers and facilitating factors considering the implementation of PAs as house officer?


Eligibility Criteria:
Inclusion criteria:

• Wards using a mixed PA/physician model (with PA ward coverage of at least 50% of the available ward hours per week, during dayshifts on weekdays) or a physician model (daily coverage by a (specialized medical doctor)

Exclusion criteria on ward level:

* Wards from specialty hospitals
* Wards with only PAs in training
* Wards with a nurse practitioner (NP) in the role of house officer (NP, NP/MD or PA/NP/MD model)
* Pediatric and psychiatric wards, intensive care units

Exclusion criteria on patient level:

* Terminal patients
* Not fluent in Dutch language
* Age \< 18 years
* Patients in daycare
Treatment of Malignant Strictures in Esophagus and Gastroesophageal Junction With Covered or Partially Covered Stent.

Self expandable stent (SEMS) constitutes the main palliative treatment in advanced esophageal cancer. The palliative effect of SEMS is immediate when it comes to relief of dysphagia. The duration of this effect is however questionable. The design of SEMS can be of importance since the device can dislodge and as a consequence of that dysphagia recur. The hypothesis has therefore been formulated that a partially covered SEMS is associated with less tendency to dislocate as compared to those SEMS, recently developed, which are covered through their entire length.


Eligibility Criteria:
Inclusion Criteria:

* Verified Squamous Cell Carcinoma or Adenocarcinoma of esophagus or Gastro Esophageal Junction (GEJ)
* Age above 18 years.
* Dysphagia scoring grade two or worse
* Not amenable for curative treatment
* Informed consent to participate

Exclusion Criteria:

* Concomitant cancer disease
* Inability to comply with study protocol
* Previous stent treatment
* Proximal location of the tumour in the esophagus.
* Need for more than one stent deployment.
CellAdhesionMolecule EndometriosisRatio - CAMERA

Background: Endometriosis, which is characterized by the growth of endometrial stroma and glands outside of the uterine cavity, is estimated to occur in 6-10% of women of reproductive age. Clinical presentation of endometriosis can vary widely, often significantly reducing quality of life, and the mean interval between the onset of symptoms and obtaining a definitive diagnosis is approximately 10 years. Currently, laparoscopy is the gold standard for diagnosing endometriosis; however, this procedure is invasive, carries surgery-related risks, and contributes to diagnostic delay. Therefore, the field has an urgent need for an efficient, sensitive, non-invasive tool for diagnosing endometriosis.

Recently, it was shown that sVCAM-1/sICAM-1 ratio is a promising serum biomarker, which may lead to the development of a new, efficient, sensitive, non-invasive tool for diagnosing endometriosis, thereby potentially avoiding surgical interventions.

Primary aim: To determine whether the serum sVCAM-1/sICAM-1 ratio can be used todiagnose endometriosis.

Study design: Prospective multicenter validation study


Eligibility Criteria:
Inclusion Criteria:

* unfulfilled desire for children
* chronic pelvic pain
* suspicion of endometriosis
* cysts
* myomas

Exclusion Criteria:

* acute infections
* malign diseases
* drug abuse
* pregnancy
* infectious diseases
Study Evaluating the Parent-child Relationship During the Hospitalisation of a Parent in Long-term Protective Isolation

The intensive treatments of certain cancers and haemopathies require the implementation of a protective isolation from external micro-organisms for a period of several weeks. This isolation implies a limitation of visitors and sometimes prohibits access to young children. This raises questions concerning the maintenance of family links, and in particular the parent-child relationship as well as the psychological and emotional isolation of hospitalised patients and the resulting psychological effects.

Telepresence robots are increasingly used as a means of remote communications, especially for teleconsultations and/or access to various public services (cultural events, education, etc.). In the context of long-term hospitalisation, they can be used for various purposes, such as access to cultural events, university activities, contact with patient's home and maintenance of family links. Some studies have analyzed the use of these robots and their effects in academic settings or the suitability of their use with elderly populations for continuing care.

To our knowledge, no study has evaluated the interest for the parent-child relationship of the use of a telepresence robot during the hospitalisation in protective isolation for a long period of a patient with young child(ren).

We propose to conduct this observational, multi-center prospective study aiming at evaluating the parent-child relationship following the setting up of a mobile telepresence robot for patients with children aged 15 years or less and hospitalised in long-term protective isolation.

Eligibility Criteria:
Inclusion Criteria:

* Age≥ 18
* Patient with at least one child aged 15 or under
* Pathology requiring a prolonged hospitalization in protective isolation
* Consent dated and signed

Exclusion Criteria:

* Impaired cognitive functions
* Performance Status -Eastern Cooperative Oncology Group (PS-ECOG) = 4
* Difficulties in speaking and understanding French
* Patient under guardianship or curatorship