cyrilzakka/clinical-trials huggingface dataset:
Clinical Performance and Reproducibility of the Accelerate PhenoTest™ Blood Culture (BC) Kit With New Antibiotic Wave I Updates

This is a performance and reproducibility study to validate new or updated antimicrobials on the Accelerate PhenoTest™ BC kit. The data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.

This clinical study entitled "Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System with New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens" is designed to demonstrate the clinical performance and reproducibility of the new or updated antimicrobials on the Accelerate PhenoTest™ BC kit, which was previously FDA-cleared in February 2017.

Clinical performance and reproducibility evaluations will be conducted at a minimum of three sites to determine the clinical performance of the new or updated antimicrobials from a combination of fresh (de-identified, remnant specimens) and contrived positive blood culture samples, to include at least 375 total specimens.

The study sites selected will have expertise in blood culture diagnostics and will be able to conduct the study in accordance with this protocol and Good Clinical Practices (GCP). Additionally, prior to study initiation, each site will have approval from the local Institutional Review Board (IRB).

It is anticipated that the data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.

Eligibility Criteria:
Inclusion Criteria:

* Blood culture positivity is ≤ 8 hours prior to initiation of testing with the Accelerate Pheno™ system
* Positive blood culture sample containing gram-negative rods according to Gram stain results
* For fresh specimens, de-identified, remnant positive blood culture specimens from patients for which Standard of Care (SOC) testing has been initiated and the remaining samples would otherwise be discarded
* A minimum sample volume of 2.0 mL
* Seeded blood culture specimens derived from archived bacterial

Exclusion Criteria:

* Blood culture positivity is \> 8 hours prior to initiation of testing with the Accelerate Pheno™ system
* Insufficient (less than 2.0 mL) remnant sample volume
* From a patient that has already been enrolled in the study
* Fresh samples from Mycobacterial-type blood culture media (BACTEC™ Myco/F Lytic, BacT/ALERT® MP Bottle, VersaTREK® Myco) or charcoal-containing media
* Seeded specimens that appear mixed (by Gram stain or purity plating) after bottle culture positivity
REDUCE Trial- Reducing Prolapse Recurrence

This study will examine whether surgeons should add a prophylactic posterior colpoperineorrhaphy to a mesh-augmented apical prolapse repair.

The decision to perform a posterior colpoperineorrhaphy at the time of sacrocolpopexy is controversial. Based on cohort data, some surgeons advocate that sacrocolpopexy alone is effective at treating posterior vaginal wall prolapse and the addition of posterior colpoperineorrhaphy only increases the likelihood of pain with defecation and dyspareunia. Experts theorize that placement of posterior vaginal mesh down to the perineal body provides adequate posterior support and reduces genital hiatus size. Others argue that placement of mesh too low on the posterior vagina may be associated with increased mesh exposure and pain secondary to mesh stiffness. No randomized trials exist comparing prolapse outcomes using new, ultra-light polypropylene mesh with and without posterior colpoperineorrhaphy. The investigators hypothesize that there will be no difference in prolapse outcomes after sacrocolpopexy using Restorelle mesh with and without posterior colpoperineorrhaphy. However, patients with a posterior colpoperineorrhaphy will be more likely to report pain with defecation and dyspareunia. This will be the first multicenter randomized trial comparing outcomes of sacrocolpopexy with and without posterior colpoperineorrhaphy.

Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 18
* English or Spanish speaking
* Symptomatic prolapse (stage II or greater) undergoing minimally-invasive sacrocolpopexy with Restorelle ultra lightweight mesh
* Preoperative genital hiatus with valsalva/strain greater than or equal to 4cm

Exclusion Criteria:

* Patient has had prior prolapse surgery
* Patient has inflammatory bowel disease (Crohn's, Ulcerative Colitis)
* Baseline dyspareunia (patient reports that they have pain with vaginal intercourse when asked as a yes/no)
* Patients with a score of 7 or greater in any one muscle on the Meister Pelvic Floor Exam
* Patient planning a concomitant Burch procedure
* Pregnant
A Study of RO5190591 (Danoprevir) in Healthy Volunteers

This non-randomized, open-label study will evaluate the interaction of RO5190591(danoprevir)/ritonavir with and without ketoconazole and the safety and tolerability in healthy volunteers. Participants will be administered repeated daily doses of ketoconazole alone, RO5190591/ritonavir, and RO5190591/ritonavir plus ketoconazole. The anticipated time on study treatment is 25 days.


Eligibility Criteria:
Inclusion Criteria:

* Adult healthy volunteers, aged 18-64 years, inclusively
* Weight \>/=50.0 kg
* Body Mass Index (BMI) 18.0-32.0 kg/m2
* Ability and willingness to abstain from alcohol, xanthine-containing beverages or food (coffee, tea, cola, chocolate, "energy drinks") from 48 hours prior to entry in the clinical study center until discharge
* Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
* Medical history without major recent or ongoing pathology

Exclusion Criteria:

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Sustained supine systolic blood pressure \>140 or \<90 mmHG and supine diastolic blood pressure \>90 or \<50 mmHG at Screening or Day -1
* Resting heart rate \>100 or \<45 beats per minute at Screening or Day -1
* Any history of clinically significant cardiovascular or cerebrovascular disease
* Positive drug test result at screening or each admission
* Donation or loss of blood over 450 ml (1 pint) within 60 days prior to screening
A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia

This is a Phase 2 multicenter, single-blind, multiple dose study to evaluate the safety and efficacy of orally administered ATR-101 in subjects with classic congenital adrenal hyperplasia (CAH). Treatment duration will range from a minimum of approximately 2 months to 6 months per subject. A subject may receive a minimum of one dose level or up to a maximum of 5 dose levels, in sequentially increasing dose strengths. Each dose level will last 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Documented historical diagnosis of classic CAH due to 21-hydroxylase deficiency based on: Documented genetic mutation in the CYP21A2 enzyme consistent with a diagnosis of classic CAH, or historical documentation of elevated 17-hydroxyprogesterone
* Biochemical marker of disease status of 17-hydroxyprogesterone ≥ 4 times the upper limit of normal
* Chronic glucocorticoid replacement therapy for at least 6 consecutive months
* Stable glucocorticoid and mineralocorticoid regimen for at least 1 month

Exclusion Criteria:

* Non-classic CAH
* Other causes of adrenal insufficiency
* Surgery within the previous 3 months prior to screening or planned surgery during study participation
* History of active cancer requiring medical or surgical therapy within the past 6 months
High-Flow Tracheal Therapy on Tracheobronchial Secretions in Tracheostomized Patients

This monocentric, randomized crossover study aims to assess the impact of high-flow tracheal therapy (HFT) on the rheological properties of tracheobronchopulmonary secretions in tracheostomized patients. The primary objective is to compare the viscoelastic characteristics of secretions collected with and without HFT. Secondary objectives include evaluating the effects of HFT on dyspnea, patient comfort, and secretion appearance. The study will take place at Cliniques Universitaires Saint-Luc, with adult tracheostomized patients undergoing standard care.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old)
* Tracheostomized patients
* Patients requiring routine tracheal suctioning and already using HFT overnight

Exclusion Criteria:

* Insufficient secretions for analysis
* Cognitive impairment or confusion
Abnormal Uterine Bleeding and Progestin-only Contraceptives

The use of progestin-only methods of contraception has been increased obviously and progressively over the world in the last few years. Progestin-only contraception is an option for women in whom an estrogen-containing contraceptive is either contraindicated or causes additional health concerns.

Progestogen-only pills are contraceptive pills that contain only synthetic progestogens (progestins) and do not contain estrogen . The progestin-only pill is recommended over regular birth control pills for women who are breastfeeding because the mini-pill does not affect milk production.

The most common progestin-only method used is the injectable depot medroxy-progesterone acetate which had been approved by Food and Drug Administration since 1992 . depot medroxy-progesterone acetate provides reliable, private, long-acting (three months) and reversible contraception. Users of depot medroxy-progesterone acetate don't need daily taking as well as it doesn't affect the intercourse by any mean.

The etonogestrel implant (Implanon) is a single-rod progestin contraceptive method placed subdermally in the inner aspect of upper non dependant arm for three years. Much evidence supports the safety, efficacy, reversibility and acceptability of this contraceptive method.

A common reason women choose to discontinue progestin-only contraception is dissatisfaction with its effects on uterine bleeding which occurs in a significant number of users. Information revealed from many clinical trials shows that abnormal uterine bleeding with progestin-only contraception ranging from 10 to 25 % at first year of use.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged between 18-40 years.
2. Women with more than 12 month postpartum.
3. Women who had normal menstrual pattern (cycle from 21 - 35 days with a same cycle length variation of no more than 5 days, bleeding days from 2-7 days and number of sanitary pads not more than 3 pads without blood clots or flooding of blood).
4. Women wanted to use DMPA, etonogestrel subdermal implant or POPs only for pregnancy prevention for at least 1 year.

Exclusion Criteria:

1. Women on any anticoagulant therapy.
2. Women who had a history of uterine, cervical or ovarian pathology.
3. Women who had uterine bleeding disturbance (including amenorrhea) before recruitment.
4. Women received DMPA injection within the previous 9 months except they had three spontaneous regular menstrual cycles.
5. Severely anemic women (hemoglobin \< 8gm/dl).
6. Women with any contraindications for POCs following the WHO eligibility (Altshuler AL et al., 2015).
7. Women refused to participate in the study.
The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery

Bariatric guidelines recommend preoperative weight loss of 5% to reduce the risk of surgical complications. However, results in the literature on the improvement of surgical procedure and outcomes are still conflicting.

This study aims to evaluate the effect of preoperative weight loss by means of a 14-day low-calorie diet in bariatric patients on operative time, the ease of the Roux-en-Y gastric bypass (RYGB) procedure and long-term weight loss in a real-life experimental setting.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing primary RYGB surgery (meeting all criteria + approval of surgeon)
* Able to prepare the meal replacements at home

Exclusion Criteria:

* Undergoing another bariatric procedure than primary RYGB.
* Diabetes Mellitus
* Contraindication for the usage of Modifast meal replacements:

  * Allergy or intolerance to any substance in the used meal replacements (Soy, milk, gluten, egg, peanuts, nuts and seeds)
  * Veganism
  * Kidney failure (GFR \< 90 ml/min/1.73m2), liver failure or cardiac insufficiency
  * A heart attack (myocardial infarct) in the past twelve months
  * Cancer
  * Hypokalaemia: serum potassium level \<3.4 mmol/l
  * Phenylketonuria \& Porphyria
A Study to Assess the Effect of High Fat Meal and Increased Gastric pH on the Bioavailability of an Extended Release Formulation of BMS-663068 in Healthy Subjects

The purpose of this study is to estimate the effect of high fat meal and increased gastric pH on BMS-663068 bioavailability


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Target population: Healthy males and females.
3. Males and females
4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test
5. Women must not be breastfeeding
6. Men and WOCBP must agree to follow instructions for contraception

Exclusion Criteria:

1. History of any chronic or acute illness or gastrointestinal disease
2. Any major surgery within 4 weeks of study drug administration
3. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
4. History of allergy to HIV attachment inhibitors, famotidine or high fat meal
5. History of smoking
Marathon and Half Marathon Runners, Older Than 70 Years Old: Who Are They?

Through this study, the investigators intend to describe the profile of marathon and half marathon runners older than 70 years old, in terms of medical, social and psychological characteristics.

First, in order to acquire a better knowledge of these aged runners: who they are; on a medical, social and psychological point of view; to figure out their motivations; to assess the impact on their life, their health and aging process.

Then, in order to be able to offer them a better medical care, in terms of prevention, treatment and follow-up care.


Eligibility Criteria:
Inclusion Criteria:

* Older than 70 years old
* Marathon or Half marathon runner
* To give an agreement to use medical datas for research study

Exclusion Criteria:

- Refusal to give an agreement to participate
Evaluation of CIED "Readers" for Disease Management

The purpose of this study is to evaluate the use of remote interrogation (readers) of CIEDs in evaluation of suspected TIA/stroke patients, HF or those experiencing syncope. This approach has the potential to advance the practice of CIED evaluation by staff without specialized training in cardiac electrophysiology (non-EP staff). We hypothesize that actionable events will be identified with use of CIED readers. These events may include identification of atrial fibrillation in TIA/stroke patients, percentage biventricular pacing in patients with HF or evaluation of arrhythmic events in syncope patients. We believe that non-EP staff will find CIED readers easy or very easy to use and that time from transmission to analysis for non-EP trained staff will be low.

Subjects with CIEDs undergoing evaluation for TIA/stroke, HF or syncope will be reviewed for inclusion/exclusion criteria. CIED interrogation, demographics and time of interrogation will be collected. Review of interrogation and medical record will be done to evaluate for actionable events including CIED programming, initiation or change in medications, admission/discharge or decision for further testing.

Eligibility Criteria:
Inclusion Criteria:

* have a Medtronic CIED compatible with Medtronic CareLink Express
* being evaluated for heart failure, TIA/stroke or syncope
* able to read and speak English

Exclusion Criteria:

-CIED from other than Medtronic
Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain.

The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot that has not formed in the heart travelled to the brain. BAY 2433334, works by blocking a step of the blood clotting process in our body and thins the blood and is a so called oral FXIa inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 45 years of age and older at the time of signing the informed consent
* Non-cardioembolic ischemic stroke with

  * persistent signs and symptoms of stroke lasting for ≥ 24 hours OR
  * acute brain infarction documented by computed tomography (CT) or MRI AND
  * with the intention to be treated with antiplatelet therapy during the study conduct
* Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess, vascular malformation)
* Severity of index event nearest the time of randomization:

  * Part A: minor stroke (defined as National Institutes of Health Stroke Scale (NIHSS) ≤ 7) can be enrolled
  * Part B: participants with minor or moderate stroke and NIHSS ≤ 15 can be enrolled. Participants undergoing thrombolysis or endovascular therapy (mechanical thrombectomy) can be enrolled but at the earliest 24 hours after the intervention
* Randomization within 48 hours after the onset of symptoms of the index event (or after patients were last known to be without symptoms in case of wake-up stroke)
* Ability to conduct an MRI either before randomization or within 72 hours after randomization

Exclusion Criteria:

* Prior ischemic stroke within last 30 days of index event
* History of atrial fibrillation or suspicion of cardioembolic source of stroke
* Dysphagia with inability to safely swallow study medication
* Contraindication to perform brain MRI
* Part A only: thrombolysis or endovascular therapy (mechanical thrombectomy) performed for index event
* Active bleeding; known bleeding disorder, history of major bleeding (intracranial, retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding within last 6 months of randomization.
A Study to Learn About the Study Medicine Called PF-07799933 in People With Advanced Solid Tumors With BRAF Alterations.

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07799933) administered as a single agent and in combination with other study medicines (called binimetinib) in people with solid tumors.

This study is seeking participants who have an advanced solid tumor with a certain type of abnormal gene called "BRAF" and available treatments are no longer effective in controlling their cancer.

All participants in this study will receive PF-07799933. PF-07799933 comes as a tablet to take by mouth, 2 times a day. Depending on the part of the study, participants may also receive another study medicine:

* People with melanoma or other solid tumors may also receive binimetinib. Binimetinib comes as a tablet to take by mouth, 2 times a day.
* People with colorectal cancer may also receive cetuximab. Cetuximab will be given weekly (or every two weeks) in the clinic as a shot given in the vein or port (intravenous, IV).

Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.


Eligibility Criteria:
This study is seeking participants who meet the following eligibility criteria:

Inclusion Criteria:

* Diagnosis of advanced/metastatic solid tumor including primary brain tumor.
* Qualifying BRAF alteration (V600 or non-V600 Class II/Class III BRAF alteration), in tumor tissue and/or blood (ie circulating tumor deoxyribonucleic acid \[DNA\], or ctDNA).
* Disease progressed during/following last prior treatment and no satisfactory alternative treatment options (Part 1 and Part 2).
* Tumor specific cohorts (melanoma, colorectal cancer) must have received specific prior approved therapies

Exclusion Criteria:

* Brain metastasis larger than 4 cm
* Systemic anti-cancer therapy or small molecule therapeutics ongoing at the start of study treatment.
* For participants who may get binimetinib on study, history or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK)
Standard Medical Management in Secondary Prevention of Ischemic Stroke in China

The purposes of the study are to analyse the cross-section data of secondary stroke prevention in China and to carry out a standard medical management including medicine and interactive education program,and to evaluate the efficacy and safety of the standard medical management in secondary stroke prevention.


Eligibility Criteria:
Inclusion Criteria:

1. Ischemic cerebral infarction or TIA within 30 days.
2. Aged above 18 years old.
3. Hospitalized.
4. Cranial CT or MRI scan exclude intracranial hemorrhagic diseases
5. Stable clinical and neurological conditions.
6. A Modified Rankin score less than 4 at enrollment
7. Informed consent is obtained.

Exclusion Criteria:

Patients will be excluded from entry if any of the criteria listed below are met

1. Documented stroke caused by conditions other than atherosclerosis, ie, surgical or vascular intervention procedure.
2. Severe co-morbid or unstable medical condition, ie, heart failure, respiratory failure and renal failure, severe liver dysfunction, malignancy with likelihood of death within the next 2 years
3. Significant memory or behavioural disorder, ie, Alzheimer disease, etc, daily care needed.
4. A Modified Rankin score is more than 4
5. Concurrent participation in another clinical trial
6. Pregnant
7. Unable to give informed consent.
DNA Methylation Biomarker for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture

DNA methylation biomarker for diagnosis of cholangiocarcinoma in patients with bile duct stricture has high sensitivity and specificity compared with cytology from the brush specimens

The methylation of HOXA1, NEUROG1 were used to determine cholangiocarcinoma from brushed biliary samples. However, the sensitivity and specificity of this test for cholangiocarcinoma is still required.

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 year old
* Patients had biliary stricture from cholangiocarcinoma and benign stricture

Exclusion Criteria:

* Pregnancy
* Patient had other malignancy
Safety and Pharmacokinetics Study of DU-176b Administered to Non-valvular Atrial Fibrillation With Severe Renal Impairment

To assess the safety and pharmacokinetics of DU-176b administered to non-valvular atrial fibrillation patients with severe renal impairment, compared with DU-176b administered to non-valvular atrial fibrillation (NVAF) patients with normal renal function or mild renal impairment (Normal/MiRI).


Eligibility Criteria:
Inclusion Criteria:

* Patients with NVAF and SRI, or patients with NVAF and Normal/MiRI.

Exclusion Criteria:

* Patients who are on hemodialysis or patients who may start hemodialysis before the follow-up assessment
* Patients who are at a significantly high risk for bleeding
* Patients who are receiving treatment with any anticoagulant drugs excluding warfarin, rivaroxaban, and dabigatran
* Patients who have evidence of hepatic function test abnormalities