cyrilzakka/clinical-trials huggingface dataset:
Comparative Oral Bioavailability Study of MT-1303

The purpose of this study is to assess the comparative oral bioavailability of a Formulation B versus the Formulation A of MT-1303.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian males aged 18 to 55 years at Screening.
* Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory, and other tests at Screening and Day -1.
* A body weight of ≥60 kilograms (kg) and BMI ranging from 18 to 30 kg/m2 at Screening or Day -1.

Exclusion Criteria:

* Presence or history of severe adverse reaction or allergy to any medicinal product or relevant excipient that is of clinical significance.
* Participated in more than three clinical studies of a new chemical entity in the previous year or participated in a clinical study of any IMP within 12 weeks or five half-lives of the IMP before the administration of the IMP in this clinical study.
* Clinically relevant abnormal medical history, physical findings, or laboratory values at Screening or Day -1 that could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator.
* Previous medical history of tuberculosis or in the opinion of the Investigator a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections, or fungal infection.
* Subjects who have received any prescribed systemic or topical medication within 14 days prior to administration of the IMP(Day 1) unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise safety. Slow release medicinal formulations considered to still be active within 14 days prior to the first dose administration will also be excluded unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study procedures or compromise safety.
Impact of Hyperuricemia on Psoriatic Arthritis

Psoriatic arthritis and gout (linked to hyperuricemia) are two rheumatisms well known to rheumatologists. There are epidemiological and physiopathological arguments in favor of a non-fortuitous link between these two rheumatisms, which to date has not been established. There is currently no recommendation to treat hyperuricaemia without an episode of gout attack. We hypothesize that there is a link between hyperuricemia and severity of rheumatism. This would ultimately modify the therapeutic management of hyperuricemic patients followed for psoriatic arthritis.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Subject with a history of psoriatic arthritis objectified according to the CIM 10-1 coding for patients followed in hospitalization at the HUS and HCC
* Subject presenting psoriatic arthritis objectified during a consultation by an HCC rheumatologist
* Among these two populations, all subjects for whom at least one serum uric acid assay was available in the medical file
* Subject having not expressed, after being informed, opposition to the reuse of their data for research purposes

Exclusion criteria:

* Subject who expressed their opposition to participating in the study
* Subject who met the inclusion criteria but whose analysis of the medical file (anamnestic, clinical, biological and radiological data) led to a diagnostic reversal and therefore did not present with psoriatic arthritis
* Subject under guardianship or curatorship
* Subject under safeguard of justice
Age-related Prevalence of Sleep Respiratory Disturbances

To determine the prevalence and longitudinal course of sleep apnea among men and women and to examine the associations of apnea, oxygen desaturation, snoring, high blood pressure, and other biomedical correlates.

BACKGROUND:

Sleep apnea is characterized by repetitive cessations of respiration during sleep with consequent decreases in arterial oxygen saturation. Sleep apnea can be caused by upper airway obstruction or by central nervous system failure to sufficiently excite the diaphragm and accessory respiratory muscles. However, in most cases, both processes are involved. Hypopneas, in which airflow is significantly compromised without complete cessations of respiratory flow, and snoring are often found in association with apneas. Both apneas and hypopneas cause repetitive disruptions of sleep, consequent daytime somnolence, and complex cardio-respiratory disturbances.

DESIGN NARRATIVE:

The study was longitudinal in design. A stratified random sample of adults in San Diego was used to examine risk factors in the prevalence of sleep respiratory disturbances. A structured random sample was selected by random digit telephone dialing. Subjects were studied in their homes. Some were followed yearly during the project. Each volunteer gave a brief sleep history and medical review, including blood pressure measurement, the National Interview Survey, And Quality of Well-being Scale. Blood oxygen saturation, pulse rate, snoring, and sleep duration were recorded for three nights. State-of-the-art computerized pulse oximeters and microprocessor-based activity/light monitors were used. Subjects found to have the most severe sleep respiratory disturbances underwent laboratory polysomnograms to add descriptive data and to validate the survey methodology. The prevalence of respiratory disturbances in sleep was analyzed as a function of age and sex. Associations with several aspects of morbidity were determined. The longitudinal course of respiratory disturbances in sleep were examined.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Iron-Biofortified Rice Intervention in the Philippines

The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice. A randomized trial of biofortified rice (IR68144-2B-2-2-3), bred to enhance iron content, was conducted among women living in convents in the greater area of Manila, Philippines for 9 months.

Iron deficiency is the most prevalent nutritional deficiency globally, with the highest burden in women of reproductive age and children. In this randomized controlled trial, 317 women aged 18-45 years living in convents in the greater Manila area, Philippines, were fed meals using either biofortified or commercially available rice for all meals, 7 days a week, for 9 months. Women living in convents in the greater Manila area were recruited for this study. These women represent a segment of the population at high risk for iron deficiency, consume large quantities of rice, and all of their meals are prepared and consumed in common kitchen and dining areas, respectively.

The investigators hypothesized that daily consumption of iron-biofortified rice (IR68144-2B-2-2-3) would improve hemoglobin, serum ferritin, and total body iron in 9 months, compared to control rice. In order to examine this hypothesis, the investigators conducted a randomized efficacy trial of iron-biofortified rice and iron status in among women living in convents in the greater area of Manila, Philippines for 9 months.

The objective of this randomized efficacy feeding trial was to determine the effects of consuming iron-biofortified rice on iron status in women, compared to non-biofortified rice.

The long-term goal of this study is to determine if iron bio-fortification of rice is an efficacious and potentially effective strategy to improve iron status of at-risk populations in resource-limited settings.

Eligibility Criteria:
Inclusion Criteria:

* Women (18-45 years old) living in convents in the greater Manila area
* Hb ≥10.5 g/dL

Exclusion Criteria:

* Current or history of gastrointestinal or hematological disorders
* Taking iron supplements or medications that could interfere with hematopoiesis or dietary iron absorption
* Hb \<10.5 g/dL
* Women expressed uncertainty in their ability to participate for the full (9 month) trial
Long-term Follow Up of Viral Hepatitis in Uremic Patients in Taiwan

The linkage between viral hepatitis and renal failure is complex. The current study aims to exlore the long-term prevalence of viral hepatitis among uremic patients in Taiwan

Patients are prospectively recruited from 15 hemodialysis units including one medical center, 3 satellite hospitals and 11 local clinics in Taiwan. Patients who provided informed consents for blood tests including genetic study related to HCV spontaneous seroclearance are enrolled for analysis. All the eligible subjects are tested for both HCV antibodies (third-generation, enzyme immunoassay; Abbott Laboratories, North Chicago, IL) and hepatitis B surface antigen (HBsAg). HCV RNA is tested by polymerase chain reaction (Cobas Amplicor Hepatitis C Virus Test, V.2.0; Roche Diagnostics, Branchburg, New Jersey, USA; detection limit: 50 IU/ml) twice for at least 6 months apart if anti-HCV is positive to ensure chronicity of HCV infection. HBsAg is quantified with the use of a standard quantitative chemiluminescent microparticle immunoassay (ARCHITECT HBsAg, Abbott Diagnostics). The concentration of HBsAg in the specimen is determined using a previously generated Architect HBsAg calibration curve (range, 0.05-250 IU/mL). Samples with serum HBsAg titer \>250 IU/mL were diluted at 1:20 and 1:500 with the Architect HBsAg diluent and retested to expand the upper limit of the dynamic range from 250 to 125,000 IU/mL. Serum HBV DNA is determined by a standardized automated quantitative PCR assay (Cobas Amplicor HBV Monitor; Roche Diagnostics; detection limit 200 copies/ml) if patients are seropositive for HBsAg.

Eligibility Criteria:
Inclusion Criteria:

* uremic patients

Exclusion Criteria:

* Nil
The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery

The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss and red blood cell transfusion during high risk spine surgery.

There are conflicting studies in the literature reporting different efficacy outcomes for the use of antifibrinolytics in spine fusion surgery. Several studies support the successful use of tranexamic acid for major orthopedic procedures, but the patient populations studied for spine surgery thus far have been small and highly variable, with less than clinically significant results. If TXA if efficacious in reducing not only perioperative blood loss, but RBC transfusion without an increase in thromboembolic events, then its use may be justified for patients at risk for major blood transfusion.

Eligibility Criteria:
Inclusion Criteria:

* age\>17 years
* undergoing posterior spine fusion surgery for kyphoscoliosis with a \>80% chance of major transfusion

Exclusion Criteria:

* age \< 18 years
* non-English speaking
* pregnancy
* emergency procedures
* surgery for tumor, trauma or infection
* severe coronary artery disease
* history of venous thromboembolism
* history of cerebral vascular accident
* history of renal insufficiency
* allergy to tranexamic acid
Exclusion of Intra-atrial Thrombus Before Catheter Ablation

Atrial fibrillation is the most frequent heart rhythm disorder. Its symptomatic forms, resistant to drug therapy, require invasive management (catheter ablation), which exposes to potentially serious complications including thromboembolic complications. Despite anticoagulant treatment, intra-atrial thrombus, which is a contraindication to catheter ablation, is detected in nearly 2 % of cases. Its diagnosis requires prior transoesophageal echocardiography, an unpleasant examination.

A previous study (NCT02199080) showed that a zero ATE score, defined by no heart failure, no hypertension, no history of stroke, d-dimer \< 270 ng/mL, has a negative predictive value of 100 % for the exclusion of intra-atrial thrombus.

The objective of the study is to confirm the negative predictive value, sensitivity and specificity of the ATE score for the exclusion of intra-atrial thrombus.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients,
* Patients hospitalized for ablation of atrial fibrillation or symptomatic left atrial tachycardia,
* have signed or orally given an informed consent

Exclusion Criteria:

* Contraindication to transoesophageal echocardiography,
* Transoesophageal echocardiography made in another centre than the centre of ablation,
* Pregnant women, parturient mothers and nursing mothers,
* Lives in an institution on court or authority order,
* Severely altered psychological health,
* Persons leaving in health or social establishment,
* Minors,
* Under guardianship,
* Persons unable to give their consent,
* Refusal to participate in the study.
Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon

This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy.

This study will also use to evaluate the administrative feasibility and data management of study design.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is between 50 - 75 years of age, and an appropriate candidate for polyp screening.
2. Subject received an explanation about the nature of the study and agrees to provide written informed consent.

Exclusion Criteria:

1. Subject has a history of colorectal cancer
2. Subjects with history of any positive colon assessment (including CT, colonoscopy, sigmoidoscopy etc.),
3. Subject with history of negative colon assessment (including CT, colonoscopy, sigmoidoscopy etc.) \< 5 years.
4. Subject has a first degree relative diagnosed with colorectal cancer before the age of 60 years old or 2 (or more) first degree relatives diagnosed with colorectal cancer at any age.
5. Subject is suspected or diagnosed with familial adenomatous polyposis.
6. Subject is suspected or diagnosed with hereditary nonpolyposis colon cancer.
7. Subject is suspected or diagnosed with inflammatory bowel disease, or chronic ulcerative colitis or Crohn's disease.
8. Subject is suspected or diagnosed with hematochezia, melena, Fe deficiency anemia or any other rectal bleeding., including positive FOBT test of any variety
9. Subject is suspected or diagnosed with bowel obstruction.
10. Subject has dysphagia or any swallowing disorder.
11. Subject has congestive heart failure.
12. Subject has Diabetes.
13. Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months or other uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
14. Subject has a cardiac pacemaker or other implanted electro medical device.
15. Subject has any allergy or other known contraindication to the medications used in the study.
16. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
17. Subject with any condition believed to have an increased risk for capsule retention such as intestinal tumors, radiation enteritis, and incomplete colonoscopies due to obstructions or NSAID enteropathy.
18. Subject with strictures, fistulas and/or chronic constipation.
19. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
20. Subject with known gastrointestinal motility disorders.
21. Subject has known delayed gastric emptying.
22. Subject has any condition, which precludes compliance with study and/or device instructions.
23. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
24. Subject suffers from life threatening conditions.
25. Subject currently participating in another clinical study.
Assess Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban in Healthy Adult Participants

The primary objective of the study is to determine whether aspirin alone or aspirin combined with various doses of rivaroxaban causes subclinical GI blood loss as determined by the HemoQuant assay.

The secondary objective of the study is to evaluate the safety and tolerability of aspirin alone or in combination with rivaroxaban to healthy volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

1. Has a body mass index between 18 and 32 kilograms per metered square (kg/m2), inclusive
2. Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed during screening
3. Is in good health based on laboratory safety testing obtained at the screening visit
4. Willing and able to abstain from alcohol use for the duration of the study

Key Exclusion Criteria:

1. History of anemia, abnormal bleeding (including vaginal bleeding or excessive menstrual periods), previous diagnosis of bleeding diathesis, or blood clots as defined in the protocol
2. History, in the last year, of any bleeding GI lesions such as peptic ulcer, hemorrhoids or anal fissure, or a positive fecal occult blood test performed either during screening or on Day 1
3. Presence of irregular stool patterns, constipation, or frequent diarrhea that, in the opinion of the investigator, may interfere with stool collections required by the protocol
4. Inability to refrain during study period from activities with high risk of bleeding or trauma such as planned surgery, contact sports, etc.
5. Hemoglobin levels below the lower limit of normal as defined by local laboratory at screening; the lab may be repeated once if initially abnormal
6. PT and aPTT values above the upper limit of normal as defined by the local laboratory during screening; the lab may be repeated once if initially abnormal
7. Platelet count below the lower limit of normal as defined by the local laboratory during screening; the lab may be repeated once if initially abnormal
8. History of clinically significant respiratory, hepatic, renal, GI, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation.

   History of any atherosclerotic cardiovascular disease
9. Presents any concern to the study investigator that might confound the results of the study or poses an additional risk to the participant by their participation in the study
10. Has received a COVID-19 vaccination within 1 week of day 1 of the study or for which the planned COVID-19 vaccinations would not be completed 1 week prior to day 1 of the study.

NOTE: Other protocol defined inclusion / exclusion criteria apply.
The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for Treatment of Pressure Ulcers

To investigate whether an oral nutritional supplement of a mixture of arginine, glutamine and HMB for a maximum period of four weeks is more beneficial than the standard dietary approach to the healing of pressure ulcers, and to examine whether the use of it can reduce admissions and length of hospitalizations for these patients.

All patients would be assessed by a dietitian to ensure them receiving nutritional support of at least 30 kcal/kg/day and of at least 1.2 g/kg/day of protein regardless of feeding method. During the study period, vitamin C and zinc supplement would not be given. Nutritional supplement other than that provided by the dietitian to meet the energy and protein requirement would not be given. The pressure ulcers would be cared according to the "Basic nursing standards for patient care: Wound dressing - Version 5" published by the Hospital Authority Head Office.

The treatment group would also be given 2 Sackets of a mixture of arginine, glutamine and HMB (ABOUND) every day for a maximum period of 4 weeks, either orally or via enteral feeding.

Eligibility Criteria:
Inclusion Criteria:

1. Inpatients of medical and geriatric wards of OLMH and WTSH
2. Aged 18 and older with stage III - IV lesions
3. Patients fed orally or through feeding tubes were included

Exclusion Criteria:

1. Patients with history of using the nutritional supplement (ABOUND) in previous three months
2. Patients with cellulitis, wounds with purulent discharge or osteomyelitis or sepsis
3. Patients requiring protein restriction
4. Patients with poorly controlled diabetes mellitus (latest HbA1C \> 8.5) (healing process may be affected
5. Patients under palliative care
Acceptability Study of Vaginal Films for HIV Prevention

This study is being done to find out what women would want in a film vaginal product for human immunodeficiency virus (HIV) prevention, especially what it should look like and how to apply it.

The investigators hypothesize that women will prefer a smooth, clear, and rectangular quick-dissolve vaginal film for HIV prevention over a textured, opaque, square quick-dissolve vaginal film.

The lives of 25 million people have ended due to HIV-related causes since the start of the AIDS epidemic in 1981 (1). Each year, AIDS continues to claim the lives of millions of people, with an estimated two million deaths worldwide in 2008 (2). Heterosexual transmission of HIV accounts for the majority of new infections and disproportionately affects women both in the United States and globally (2, 3). There is an urgent need for agents to prevent the sexual transmission of HIV, particularly agents that may be controlled by women.

Quick dissolve films such as Listerene® Breath Strips have been developed for inexpensive delivery of drugs and vitamins. As products for HIV prevention, quick dissolve films offer a host of potential advantages including low cost, control by the receptive partner, discreet and applicator-free use, low mess, portability, easy storage, stability, targeting to site of exposure, reduction of systemic toxicity by bypassing first-pass metabolism, and the incorporation of multiple active microbicidal compounds (4, 5).

In the course of developing agents for HIV prevention, determination of valued characteristics is important for product refinement and for enhancement of future use likelihood. Knowledge regarding acceptability can also inform product promotion and educational campaigns (6).

Eligibility Criteria:
Inclusion Criteria:

* Female 18-30 years old at time of enrollment
* Able to provide written informed consent

Exclusion Criteria:

* Not sexually active, defined as no vaginal sex at any time in the past year
* Pregnant by self-report