cyrilzakka/clinical-trials huggingface dataset:
Vitamin K2 Supplementation to Activate Matrix Gla Protein (MGP) as Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients

Vascular calcification (VC) is a predictor of cardiovascular morbidity and mortality. Hemodialysis (HD) patients suffer from severe vascular calcifications. Matrix Gla protein (MGP) is a central calcification inhibitor of the arterial wall and its activity depends on vitamin K-dependent γ-glutamate carboxylation. Noncarboxylated MGP, formed as a result of vitamin K deficiency, is associated with cardiovascular disease. Recent studies pointed towards poor vitamin K status in HD patients. We therefore aim to investigate whether daily vitamin K2 (MK-7) supplementation improves the bioactivity of vitamin K-dependent proteins in HD patients as assessed by circulating dephospho-noncarboxylated MGP (dp-ucMGP), noncarboxylated osteocalcin (ucOC) and noncarboxylated prothrombin (ucFII; PIVKA-II).


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* minimum of 3 months of hemodialysis
* written consent

Exclusion Criteria:

* chronic or acute bowel disease
* soy bean allergy
* active Vitamin K Supplementation
* oral anticoagulation with vitamin K Antagonists (coumarins)
* systemic therapy using steroids
* positive history for thrombosis or embolism
* pregnancy
Feasability of Lung Ultrasonography in General Practice

A major barrier to ultrasonography in general practice (GP) is the time restriction of their medical consultation. We aimed to evaluate the feasibility of lung ultrasonography (LUS) realized by general practitioners (GP's) into their medical consultation.

A prospective, observational, multi-centric and open study conducted in 3 different centers by 15 GP in France. Patient receiving LUS were recruited from December 2019 to January 2020. GP's were all novices and received a training course by LUS expert before the study. Eight-points LUS exam was recorded, timed, and interpreted by GP's.

Among the 111 LUS performed, 110 LUS were interpreted. Time duration was 4 (3-5) min with 13% of LUS superior to 5 minutes. There was no significant difference in time duration after stratification by age. Patients were mainly satisfied after receiving LUS, and 80% of patients had a better understanding about their disease due to US realization.

In this first prospective, and multicenter study, involving patients consulting in General Practice, we found that LUS seems to be feasible by GP's in a medical consultation. We showed that LUS can be performed fast enough for a GP consultation, and easy to learn. These findings will need to be valided in a randomized and controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 3 months; lung ultrasonography performed by GP

Exclusion Criteria:

* Age \< 3 months or rejection to participate to the study
A Pharmacokinetic Study to Assess Dose Proportionality, Safety and Tolerability of Diazepam Nasal Spray in Healthy Adult Volunteers

This is a single-center, two-period, randomized, open-label, crossover pharmacokinetic (PK) study in healthy adult volunteers to evaluate dose proportionality of diazepam nasal spray using two dose levels


Eligibility Criteria:
Inclusion Criteria:

* Screening body weight 88 to 111 kg, inclusive;
* General good health with no clinically significant abnormalities that would affect ability to complete study as determined by medical history, physical examination, visual evaluation of the septum and turbinates to document baseline anatomy, electrocardiogram, clinical laboratory test results;
* Negative drug and alcohol testing;
* Negative pregnancy test for female subjects of childbearing potential.

Exclusion Criteria:

* Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product;
* In the judgment of the Investigator, any clinically significant abnormality (such as septal perforations) or illness that would interfere with participation in this study as determined by medical history, physical examination (including visual exam of septum and turbinates), ECG, clinical laboratory results, or other screening safety tests;
* Any other condition and/or situation that causes the investigator to deem a subject unsuitable for the study.
Usefulness of Medroxyprogesterone Acetate in Follicular Phase in Oocyte Donors. Undergoing Ovarian Stimulation

The purpose of this study is to determine whether Medroxyprogesterone Acetate (MPA) administration in follicular phase prevents premature luteinization with equal efficiency as GnRH antagonists and otains similar clinical results in oocyte donation.

Within the new guidelines for stimulation, the use of oral progesterone in follicular phase allows GnRH analogue administration, resulting in greater comfort for patients as well as a reduction in cost. Obtained results are similar to those from conventional protocols in terms of: early luteinization, number of oocytes, embryos number and rate of implantation and gestation or appearance of congenital malformations. Another advantage is the lower incidence of OHSS (Ovarian Hyperstimulation Syndrome).

From a scientific point of view, it would allow a better understanding of folliculogenesis, of progesterone mechanism of action on blocking LH secretion and its effect on ovarian and later embryonic level.

From a clinical point of view, it would simplify COS (Controlled Ovarian Stimulation) by reducing the number of medication administered subcutaneously and their possible side effects on both systemic and local levels. It would be of special interest in 2 groups of patients, for example, oocyte donors and patients undergoing preservation of fertility. To date, there is a lack of studies along these lines.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-35 years (both included)
* Regular Menses (between 25-35 days)
* Absence of physical and psychic pathologies at the time of oocyte donation
* BMI: 18-28 kg(m2 at the time of oocyte donation.
* Other criteria to comply with:

  i. With no relevant personal or family medical history ii. Signing of Informed Consent iii. From a medical point of view:
  1. Healthy ovaries and uterus, with no organic pathology
  2. Ovaries without polycystic aspect
  3. Antral Follicle Count \> 12 in the sum of both ovaries
  4. Normal Karyotype
  5. Negative results in infectious illness screening (Hepatitis B Virus; Hepatitis C Virus, VIH Virus Syphilis)
  6. Results within range of general analysis of hemogram, hemostasia y biochemistry.

     Exclusion Criteria:
* Any systemic or metabolic disorder which contraindicate the use of Gonadotrophines
* Medical background of Trombophlebitis or thromboembolic phenomena or Arterial Hypertension
* Severe hepatic insufficiency, cardiovascular illness
* Suspicion or evidence of malignity of mamarian glands or other hormone dependant genital organs
* Known infection of Hepatitis B Virus; Hepatitis C Virus or VIH Virus
* Known hypersensitivity to PMA or its excipients
* Any reason or cause which excluede from the oocyte donation program
* Participation in another clinical trial in the two months prior to the inclusion on this study
Educational Needs of Patients With Systemic Vasculitis

A cross-sectional study design and online questionnaire was used to assess the informational needs of patients with several different types of systemic vasculitis. Patients were recruited from within the Vasculitis Clinical Research Consortium (VCRC) online Patient Contact Registry1. Survey responses from participants in the VCRC Patient Contact Registry were compared to responses from a similar survey recently administered to patients within a United Kingdom (UK) based vasculitis support group (Vasculitis UK).

All patients enrolled in the Vasculitis Clinical Research Consortium's Contact Registry were invited via email to participate in this study. The Contract Registry includes people who self-identify as having one of the following types of vasculitis: Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, or Takayasu's Arteritis. People voluntarily enroll in this Registry with the understanding that they will receive information about clinical studies for which they might be eligible. The introductory email included basic information about the study and all of the required elements for informed consent in a brief format. Once participants agreed to participate in the study, they were directed to the online questionnaire.

When completing the questionnaire, the patients were asked a series of questions. The questionnaire content was included as an appendix. The online questionnaire version was thoroughly tested for usability.

It was expected that most participants wouldrequire approximately 10-15 minutes to complete the questionnaire.

The survey data is stored by the Rare Diseases Clinical Research Network Data Management and Coordinating Center (DMCC) at the University of South Florida. The data is de-identified. Names or other personal health information were not collected.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the VCRC Contact Registry
* Patient reported diagnosis of Behçets disease, Churg-Strauss Syndrome, CNS Vasculitis, Giant Cell Arteritis, granulomatosis with polyangiitis (Wegener's granulomatosis), Henoch-Schöenlein Purpura, Microscopic Polyangiitis, Polyarteritis Nodosa, Takayasu's Arteritis.
* 18 years of age or older
* English speaking

Exclusion Criteria:

* Inability to provide informed consent and complete survey
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Fluoxetine Tablets Under Fed Conditions

Subjects to compare the single dose bioavailability of Torrent's Fluoxetine Tablets 20 mg and Sarafem® 20 mg Tablets of Warner Chilcott LLC, USA. Dosing periods of studies were separated by a washout period of 35 days.

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Fluoxetine Tablets containing Fluoxetine 20 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Sarafem® 20 mg Tablets containing Fluoxetine 20 mg (Reference, Warner Chilcott LLC, USA) in Healthy Human Volunteers Under Fed Condition.

Eligibility Criteria:
Inclusion Criteria:

* Sex: male
* Age: 18-45 years (inclusive both)
* Volunteer with BMI of 18.5-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
* Healthy and willing to participate in the study.
* Volunteer willing to provide written informed consent.
* Non-smokers or smoker who smokes less than 10 cigarettes per day.

Exclusion Criteria:

* Inability to communicate or co-operate.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of pre-existing bleeding disorder.
* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* HIV, HCV, HBsAg positive volunteers.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* Participation in any study within past 3 months,
* History of alcohol or drug abuse.
* History of consumption of prescribed medication since last 14days or OTC medication/ herbal remedies since last 7 days before beginning of the study. Positive to Breath alcohol test.
* Positive to breath alcohol test.
* Volunteer found to be positive for Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Systolic blood pressure less than 100 mmHg or more than 139 mmHg and diastolic blood pressure less than 60 mm Hg or more than 89 mm Hg.
* Pulse rate less than 60/minute or more than 100/minute.
* Oral temperature less than 95°F or more than 98.9°F.
* Respiratory rate less than 10/minute or more than 20/minute.
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* Recent History of kidney or liver dysfunction.
* Volunteers suffering from any psychiatric (acute or chronic) disorder.
* Existence of any surgical or medical condition, which, in the judgment of the Chief Investigator and/or clinical investigator/physician, might interfere with the absorption; distribution,· metabolism or excretion of the drug or likely to compromise the safety of Volunteers.
The Impact of Beef on Muscle Fatigue in Older Adults

The goal of this controlled-feeding cross-over diet intervention is to compare a beef diet to a vegetarian diet on muscle fatigue in older adults. The aims are:

AIM 1: To test the hypothesis that muscle fatigue is attenuated in older adults consuming beef compared to older adults consuming a plant-based diet.

AIM2: To test the hypothesis that daily beef consumption improves biochemical indicators related to muscle fatigue.

Participants will be randomized to consume either a beef-based diet or vegetarian diet under controlled-feeding conditions for 8 weeks. After a 2-week washout period, participants will cross-over to consume either the beef diet or vegetarian diet for 8 weeks. Body composition and functional muscle outcomes will be measured during each 8-week feeding period. Blood samples will also be collected.


Eligibility Criteria:
Inclusion Criteria

* Ages 60-85 years
* Ability to eat study diet meals for a total of 16 weeks
* Ability to perform sit-to-stand chair and 6-minute walking tests based on results from PAR-Q questionnaire
* Ability to provide fasted blood samples
* Access to transportation
* Willing to abstain from alcohol consumption and/or use illicit drug use for each 8-week intervention period
* Ability to consent to participating in this study
* English-speaking
* Body mass index between 18.5 (normal) and 39.9 (obese) kg/m2
* Minimum total body weight of 110 pounds
* Non-anemia hemoglobin values: Females - \>12.0 grams/dL; Men - \>13.0 grams/dL
* Able to ambulate without assistance
* Physician's clearance for study participation (required prior to baseline testing)

Exclusion Criteria

* Inability or refusal to sign the informed consent
* Significant orthopedic limitations or other contraindications to exercise
* Inability or refusal to perform muscle fatigue tests
* Has dietary restrictions that prevent to consumption of beef, soy and/or wheat
* Has liver or kidney complications
* Live or work \>25 miles from Bloomington study site or does not have transportation to the study site
* Anticipate elective surgery during the study period
* Diagnosis of progressive neurological disorders, musculoskeletal disorders, osteoarthritis, rheumatoid arthritis
* Fracture or serious injury in the last 6 months
* Stroke, revascularization, deep vein thrombosis, or pulmonary embolism in the past 12 months
* Severe cardiovascular disease, uncontrolled systemic hypertension, chronic pulmonary disease
* Plan to move residence or travel out of the local area during the study period
* Current use of anti-coagulants (e.g. Coumadin or Warfarin)
* Current use of prescription medications that affect heart rate or blood vessel dilation
* Psychological or social characteristics that would interfere with their ability to fully participate in the study
Biomarkers in the Diagnosis and Assessment of Pulmonary Arterial Hypertension (PAH)

The investigators hypothesize that baseline plasma brain natriuretic peptide (BNP) and migration inhibitory factor (MIF) levels are surrogate markers of clinical severity of PAH and that changes in plasma brain natriuretic peptide (BNP) and MIF levels pre and post exercise.

As above

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PAH, based on currently accepted gold standard for Right Heart Catheterization.
* Patients with mean artery pressure of greater that 25 mm Hg at rest or 30mm Hg during exercise with pulmonary capillary wedge pressure less than 18mm Hg on right heart catheterization.

Exclusion Criteria:

* Significant left heart disease or renal insufficiency (serum creatinine \> 1.5 mg%).
Pharmaceutical Literacy and Quality of Life in Spanish Population.

The goal of this study is to learn about the knowledge and abilities that patients have regarding their own medication and to see if that's related to their quality of life.

The main questions it aims to answer are:

* Are patients abilities and knowledge about their medications sufficient to ensure a safe and efective use?
* Are those knowledge and abilities related to the patient's quality of life? How?

Patients already taking at least one medication will answer questions about their abilities and knowledge towards medication and their quality of life related to their health state.

A cross-sectional study is carried out, consisting of an interview between the patients and community pharmacists included in the study.

The participants selected are adults usually taking medication that answer questions related to their pharmaceutical literacy (RALPH interview). This type of literacy refers to three domains regarding functional, comunicative and critical abilities about their own medication.

After that, every participant answers a simple survey regarding their health-related quality of life including topics such as mobility, self-care, everyday activities, pain and mental health (EQ-5D-5L survey).

The recruitment and interviewing take place at the same time, and it requires less than 30 minutes per patient. No follow-up is needed afterward.

There are no risks associated with this procedure, and the participation of the patients will always be voluntary and anonymous.

Previously to the patients' enrollment in the study, proper information will be given to the potential participants and an informed consent will be signed.

Eligibility Criteria:
Inclusion Criteria:

* Adults currently taking at least one medication prescribed by a physician and living in Spain.

Exclusion Criteria:

* Having physical or cognitive limitations that make it impossible to answer the study questions.
The Effects of Intravenous Dexmedetomidine on Spinal Anesthesia Using Low Dose Diluted Bupivacaine for Transurethral Resection of Prostate

Dexmedetomidine is a new selective and potent alpha-2 agonist. It has centrally acting anesthetic properties. It has been known that intrathecal addition of alpha-2 adrenergic agents result in prolongation of the duration of the sensory and motor blockade induced by hyperbaric bupivacaine. But the effects of intravenous dexmedetomidine on the spinal block was not evaluated. The aim of study is to assess the effect of intravenous dexmedetomidine on the low-dose spinal anesthesia for the transurethral surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA class I or II
* Elective transurethral prostatectomy
* aged \> 20

Exclusion Criteria:

* Coagulation deficiency
* infection on the back
* Congestive heart failure or arrythmia
* Chronic alcoholic disease
* Antidepressants therapy
A Study to Describe the Characteristics of Patients Treated With Apremilast for Plaque Psoriasis in Italian Routine Clinical Practice

The DARWIN study is an Italian multicenter, observational, cross-sectional study involving both a primary data collection (at enrollment visit) and secondary use of data (retrospective observation period). DARWIN will describe patients' characteristics in Italian routine clinical practice as well as the medication utilization patterns, including needs and benefits form the patient's perspective.

The DARWIN study is anticipated to enroll 375 participants from 24 Italian dermatologic departments and recruitment is expected to take approximately 20 months. Participants must have started apremilast treatment 6 (±1) months prior enrollment in order to be considered eligible. The decision to prescribe apremilast falls within current practice according to the current decision-making process in the Italian routine clinical practice and according to AIFA prescribing information. No extra-procedures (diagnostic or monitoring) will be implemented and the assessment schedule reflects the routine clinical practice for psoriatic patients treated with apremilast. Patients will be consecutively enrolled in the study and information will be collected as recorded in the medical chart before starting apremilast (as close as possible to the apremilast start date/index date), and/or directly observed during the enrolment visit. The study variables will describe patient disease and characteristics, apremilast utilization patterns, psoriasis severity a, extent and impact on patient wellbeing, apremilast safety profile and apremilast satisfaction.

Eligibility Criteria:
Inclusion Criteria:

1. Must have understood and voluntarily signed the informed consent and privacy form.
2. Age ≥ 18 years at the time of signing the informed consent and privacy form.
3. Patients with available hospital medical chart since the start of apremilast treatment ('index date').
4. Diagnosis of plaque psoriasis.
5. Treatment with apremilast for plaque psoriasis, according to Summary of Product Characteristics (SmPC), started 6 (±1) months before enrollment. Patients who interrupted apremilast treatment before enrollment will also be included.
6. Ability to understand (read \& write) the Italian language and to follow the study instructions.

Exclusion Criteria:

1. Refusal to participate in this study or current participation in the treatment phase of an interventional clinical trial.
2. Started apremilast as part of a clinical trial, or previous apremilast use (prior to the index date).
Non-contrast 3D MR Angiography for Assessment of the Thoracic Aorta in Pregnancy

Introduction: Native magnetic resonance angiography (MRA) is recommended to assess the thoracic aorta during pregnancy, avoiding the risks of ionising radiation and contrast agent administration. This guidance is however, based only on consensus opinion supported by limited case reports (level of evidence C).

Aim: To evaluate the feasibility of performing native 3D steady-state free-precession (SSFP) MRA in pregnant subjects with inherited aortopathy to guide timing and mode of delivery.


Eligibility Criteria:
Inclusion Criteria:

* Any pregnant subject with a history of familial aortopathy

Exclusion Criteria:

* None
Is the Distance of Patients From Rouen University Hospital Influencing the Time Between Colectomy and First Chemotherapy Cure for Colon Cancer?

This project has for objective to demonstrate that the increase of the distance "Patient home - center of treatment" may be associated with significant, other noticeable, noted events. This distance may also be available in the Rouen University Hospital. The study of the association in this distance and the delay in initiating chemotherapy after surgery in patients treated at the CHU correspond to a pilot study prior to the completion of the analysis at the regional scale.


Eligibility Criteria:
Inclusion Criteria:

- Patients who had colectomy for colon cancer and at least one chemotherapy treatment at CHU Rouen, between 2009 and the first half of 2015.

Exclusion Criteria:

* Patients who died in hospital before receiving a chemotherapy treatment
* Patients with a CIM code of metastasis during the stay of the colectomy or the first chemotherapy treatment
* Patients who received a chemotherapy treatment before colectomy
* Patients who have undergone several colectomies.