cyrilzakka/clinical-trials huggingface dataset:
Bag Mode BreathID Hp Validation Versus Endoscopy in Detection of Helicobacter Pylori

A new method of breath collection for testing for Helicobacter Pylori infection has been developed by Exalenz. In this study, it will be compared to the gold standard- endoscopy results to prove its accuracy.

This study will validate a breath collection method by comparing a newly developed breath test kit, IDkit:Hp™ TWO using breath collection bags, to congruent biopsy results (a composite reference standard by analyzing specimens with microbial culture, histological examination and rapid urease test- RUT) in detecting H.Pylori

Eligibility Criteria:
Inclusion Criteria:

* Present with clinical indication of H. pylori and candidate for upper endoscopy
* Have the ability and willingness to sign the Informed Consent Form for initial diagnosis cohort
* Naive to treatment in the past 18 months
* No known H.pylori status (no conclusive test results within last 6 months)

Exclusion Criteria:

* Participation in other interventional trials
* Antibiotics and/or Bismuth preparations within four (4) weeks prior to breath test
* PPI (proton pump inhibitors) or H2 blockers within two (2) weeks prior to breath test
* Pregnant or breastfeeding women
* Allergy to test substrates
Everolimus in Combination With Trastuzumab and Paclitaxel in the Treatment of HER2 Positive Locally Advanced or Metastatic Breast Cancer

The purpose of this Phase III study was to confirm the value of adding everolimus to weekly paclitaxel and trastuzumab as treatment of HER2-overexpressing metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adult Women (≥ 18 years old).
* Histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.
* Must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease.
* HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive).
* Prior trastuzumab and/or chemotherapy (taxanes included) as neo-adjuvant or adjuvant treatment is allowed but should be discontinued \> 12 months prior to randomization.
* Prior treatment for breast cancer with endocrine therapy (adjuvant or metastatic settings) is allowed but should be discontinued at randomization. Patients treated with bisphosphonates at entry or who start bisphosphonates during study may continue this therapy during protocol treatment.
* Documentation of negative pregnancy test.
* Organ functions at time of inclusion.

Exclusion Criteria:

* Prior mTOR inhibitors for the treatment of cancer.
* Other anticancer therapy for locally advanced or metastatic breast cancer except for prior hormonal therapy.
* Patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites, etc).
* Radiotherapy to ≥ 25% of the bone marrow within 4 weeks prior to randomization
* History of central nervous system metastasis.
* Impairment of gastrointestinal (GI) function or GI disease or active ulceration of the upper gastrointestinal tract.
* Serious peripheral neuropathy.
* Cardiac disease or dysfunction.
* Uncontrolled hypertension.
* HIV.
* Pregnant,
Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty

Electroacupuncture may improve cognitive function and altered consciousness, but its effect on postoperative delirium in older arthroplasty patients remains unexplored. This study aims to assess the efficacy of electroacupuncture in preventing postoperative delirium in older adults undergoing total knee arthroplasty.

Electroacupuncture combines traditional acupuncture with electrical stimulation at specific body points. Recent clinical studies have shown promising results for acupuncture-related techniques in managing perioperative neurocognitive disorders. However, the efficacy of electroacupuncture in preventing postoperative delirium in elderly patients undergoing total knee arthroplasty remains unexplored.This randomised controlled trial aims to evaluate the efficacy of electroacupuncture in preventing postoperative delirium in elderly patients undergoing total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65-90 years
* American Society of Anaesthesiologists (ASA) physical status class II or III
* Scheduled for elective unilateral total knee arthroplasty under general anesthesia

Exclusion Criteria:

* Baseline dementia or Mini-Mental State Examination (MMSE) score below 24
* Implanted electrical devices (eg, pacemakers, brain or spinal cord neurostimulator)
* Infection or abscess at any selected acupuncture point
* Severe hematopoietic or hemorrhagic disease
* Severe audio-visual impairments or inability to communicate in Mandarin
* Alcohol or illicit drug misuse disorder
* Current use of sedatives, antidepressants or glucocorticoids
* Received acupuncture or electroacupuncture within one month before surgery
* Any condition deemed unsafe or unsuitable by the research team
BC Women's Hospital Noise Pilot

The effect of noise is often underestimated but it is one of the most common occupational health hazards. Its health effects include; noise-induced hearing loss, sleep disturbance, interference with speech comprehension, complaints, stress, annoyance, and safety concerns with regard to workers being able to complete their tasks in a safe manner.

This pilot aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital during elective and emergency cesarean deliveries.

This is a pilot study that aims to measure and analyze noise levels in obstetric ORs at BC Women's Hospital during elective and emergency cesarean deliveries.

The investigators want to quantify the amount of noise in BCW ORs in order to create a research question for a larger study.

Eligibility Criteria:
Inclusion Criteria:

* BCW staff members
* Presence in OR during Cesarean section
* Willing to have a personal dosimeter pinned to hospital scrubs lapel

Exclusion Criteria:

- unable to read and understand English for the purpose of informed consent and perioperative communication
A Study Exploring the Safety, Tolerability, and Efficacy of a 28 Day Course Followed by an Additional 56 Day Course of Itacitinib in Subjects With Active Rheumatoid Arthritis

This is a study evaluating a 28-day course followed by a 56-day course of itacitinib in patients with active rheumatoid arthritis (RA). The study will evaluate safety and efficacy parameters of itacitinib.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with active RA aged 18 to 75 years of age and meet tender and swollen joint assessment expectations defined in the study protocol.
* c-Reactive protein (CRP) or erythrocyte sedimentation rate (ESR) laboratory values meet minimal study protocol expectations.

Exclusion Criteria:

* Females who are pregnant or breastfeeding.
* Men and women who cannot comply with requirements to avoid fathering a child or becoming pregnant, respectively.
* Subjects treated with a biologic agent within 12 weeks prior to first dose of study drug. (12 months in the case of rituximab.)
* Subjects with a history or currently suspected inflammatory disease other than RA.
* Subjects with a history of hematological disorders.
Advancing the Health of Rural Communities in Uganda Through Strong Community Health Programs

The overarching goal of this study is to improve the health of women and children in rural areas of Uganda through strengthening of the community health workforce, which provides critical health services to the rural poor.

Uganda, like several countries in Sub-Saharan Africa, faces a shortage of skilled healthcare workers, and a disproportionate concentration of workers in urban areas. This disparity has dire consequences for rural populations, who have higher fertility rates, lower utilization of maternal and child health services, lower levels of access to safe drinking water and sanitation services, and poorer vaccination coverage. Women and children in rural and remote communities bear the disproportionate brunt of poor access to and poor quality of health care. Village Health Teams (VHTs), Uganda's community health workers (CHW), were introduced to address some of these inequities by providing basic health services to the rural poor. However, like many CHW programs globally, the VHT program has high levels of attrition, owing to inadequate systems and financial support.

The objectives of this study are to understand:

1. What structure and group of incentives is best suited to motivate VHTs, improve their performance in the delivery of services, and increase their retention in the health workforce?
2. What is the behavioral mechanisms through which new incentives may work or fail to work?
3. How do the changes in the national VHT program impact utilization of maternal and child health services, sanitary practices, and perception of quality of health services at the community-level? What is the impact of COVID-19 on VHT practices on community health?

This study will evaluate a 1-year incentives intervention provided to VHTs in Uganda's Masindi District. It is a two-armed clinical trial, where parishes will be randomized to the incentives intervention (i.e., an incentives package will be provided to VHTs practicing in the intervention parishes; control parishes VHTs will not receive an incentives package). The primary outcomes include assessing VHT performance, VHT motivation, VHT retention, trends in utilization of maternal and child health services, and trends in the adoption of sanitary practices. Outcomes for VHT performance, VHT retention, trends in utilization of maternal and child health services, and trends in adoption of sanitary practices will be measured monthly. Outcomes for VHT motivation will be measured twice, at baseline (Month 1) and endline (Month 12).

Eligibility Criteria:
Inclusion Criteria:

* Must be an active VHT in Uganda's Masindi district.

Exclusion Criteria:

* Anyone who fails to meet the inclusion criteria specified above will be excluded.
Hamburg TranscathEteR Mitral Valve REplacement RegiStry

The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with mitral valve disease that undergo transcatheter mitral valve replacement (TMVR) screening. In particular, long-term durability and function of implanted bioprosteses is of utmost interest for both patients and clinicians. Moreover, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR.

Mitral valve regurgitation (MR) emerges as the most frequent valvular heart disease in developed coun-tries with prevalence increasing with age. Mitral valve repair is the gold standard therapeutic strategy in primary MR and is recommended in patients with secondary MR who are in need of revascularization. However, in patients with secondary MR mitral valve repair is associated with a higher rate of MR recurrence compared to mitral valve replacement. Nevertheless, elderly patients often are at high or prohibitive surgical risk and up to one half of all patients with severe MR are not referred to surgery. Transcatheter edge-to-edge mitral valve repair (TEER) constitutes a feasible and effective alternative, but eligibility for TEER is limited in some cases due to suboptimal anatomy or risk of mitral stenosis. Moreover, MR reduction is less predictable and, again, MR may reoccur. Transcatheter mitral valve replacement (TMVR) represents a complementary therapeutic approach for patients with severe MR. This novel therapy promises to reduce MR as durable as surgical valve replacement while reducing the procedural risk with an interventional approach.

The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with significant mitral valve disease, at high surgical risk with suboptimal anatomy for TEER, who undergo TMVR screening. In particular, long-term durability and function of implanted bioprosteses will be investigated. Additionally, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR (i.e., TMVR, TEER, surgery and medical therapy).

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation.
* Individuals over the age of 18 years.
* Patients with clinically relevant mitral valve disease, who undergo screening for TMVR.

Exclusion Criteria:

* Insufficient knowledge of the German language, to understand study documents and interview without translation
* Physical or psychological incapability to cooperate in the investigation
Comparison of Pressure-, Flow- and Neurally Adjusted Ventilatory Assistance (NAVA)-Triggering in Pediatric and Neonatal Ventilatory Care

The purpose of this study is to study whether neurally adjusted ventilatory assist (NAVA) provides advantages over current methods in detecting patients own breathing efforts in pediatric and neonatal ventilatory care.

Our study hypothesis is that NAVA-technology is more accurate than currently used methods in detecting and assisting spontaneous breathing in children, and thus the patient-ventilator synchrony will improve.

Asynchrony means that the timing of support given by the ventilator is different from patients own breathing pattern. Asynchrony during ventilatory care may increase the risk for complications, make the weaning more difficult and may affect the survival rates.

In this study we will compare two currently used methods pressure- and flow-triggering with a neurally adjusted ventilatory assist in synchronization of the ventilator support with patients own efforts.

Eligibility Criteria:
Inclusion Criteria:

* All children born over 30 weeks of gestation needing ventilatory care

Exclusion Criteria:

* Craniofacial malformation which does not allow feeding tobe positioning. Critical ventilatory or perfusion problems.
Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis

The objective of this study is to determine whether creatine slows disease progression in subjects with amyotrophic lateral sclerosis (ALS). ALS is a progressive uniformly lethal neurodegenerative disorder for which there is no known cure. Recent genetic and biochemical studies implicate free radical toxicity, glutamate excitotoxicity and mitochondrial dysfunction as possible causes of familial ALS (FALS) and sporadic ALS (SALS). It has been hypothesized that in ALS there may be involvement of oxidative free radical damage and impaired mitochondrial energy metabolism that could in turn lead to excitotoxic cell death. Creatine, an agent that improves mitochondrial function, has been shown to be neuroprotective in animal models of ALS and Huntington's disease.

This study is a double-blind, randomized, placebo-controlled trial of the safety and efficacy of creatine in patients with ALS enrolled at sites distributed throughout the United States, including Northeast ALS (NEALS) sites. The study will provide preliminary data on the safety and efficacy of creatine in ALS. If creatine slows disease progression in ALS and is well tolerated, a phase 3 study with survival as the primary outcome measure will be initiated.

114 eligible subjects will be randomized to receive treatment for 6 months of (1) active creatine or (2) placebo. After randomization, subjects will be followed prospectively for 6 months. The primary outcome measure for the study is the change in upper extremity motor function after 6 months of experimental therapy as tested with the Tufts Quantitative Neuromuscular Exam. Strength in eight arm muscles will be measured (bilateral shoulder and elbow flexion and extension). Secondary outcome measures include grip strength, motor unit number estimates (MUNE), the ALS functional rating score-revised (ALSFRS-R), and rate of change of a well established biochemical marker of oxidative damage to DNA (8OH2'dG levels in urine), and the safety and tolerability of creatine.


Eligibility Criteria:
Inclusion Criteria:

* ALS
* FVC \>=50%
* Abnormality in upper and/or lower extremity motor function
* Not pregnant
* Disease duration \<5 years
The SPINUS I Study: Spinal Fusion for a Single Level SPECT/CT Positive Lumbar Degenerative Disc Disease

The aim of the present study is to find out whether fusion of a sinlge level SPECT/CT positive degenerative disc disease leads to a significant improvement of pain and disability.

Chronic back pain (CBP) is a very common clinical problem. It is dominantly caused by degenerative changes, while specific causes such as tumor, trauma or inflammatory conditions are relatively rare. Back pain may be a concomitant symptom of lumbar disc herniation or spinal canal stenosis and is a typical symptom of spondylolisthesis. Magnetic resonance imaging (MRI) plays a key role in the diagnosis, showing in detail the soft structures, vertebral bodies (Modic changes, MC) or signs of facet arthropathy. On the other hand, it also proves a number of clinically silent findings. Degenerative disc disease (DDD) or facet osteoarthritis are most often considered to be a pain generator. The problem, however, is that both entities are very common in the general population without a painful correlate, and there is still controversy in the literature about their role in the genesis of CBP.

Radionuclide bone scintigraphy with single photon emission computed tomography (SPECT) provides functional imaging and is used to detect microcalcification due to increased osteoblastic activity. In the absence of other pathology the foci of increased osteoblastic activity reflex areas of mechanical stress and degenerative change in the skeleton. There is growing evidence about the relationship between DDD, facet arthropathy, and SPECT positivity. Although these findings have been recently confirmed by surgical studies, the evidence about the effect of surgical treatment of SPECT positive lumbar degeneration is still weak due to the small number of operated patients.

The aim of the present study is to define a possible correlation between degenerative changes of the lumbar spine and positivity on SPECT/CT imaging. Patients with a single level SPECT+ DDD will undergo spinal fusion of the involved segment. Postoperative improvement will be measured by ODI (Oswestry Disability Index) and pain VAS (Visual Analogue Scale) in 6 and 24 months follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Lower back pain (in extension +/- pain in buttocks, groin, thigh) without radicular pain
* Symptoms \> 6 months after failure of conservative management in the primary care setting
* MRI signs of degenerative disc disease or facet arthropathy
* One-level positivity on lumbar SPECT/CT

Exclusion Criteria:

* Other spinal pathology (tumours, congenital defects, spondylolysis or spondylolisthesis)
* Intolerance of SPECT examination
* Pregnancy
Assessment of Onset, Safety & Toleration of UK-369,003 in Male Erectile Dysfunction

To determine the onset of action, safety and toleration of different formulations and doses of UK-369,003 in patients with erectile dysfunction. Patients should have been previously treated with PDE5 inhibitors and have been responders to the drugs. Duration of treatment is 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Erectile dysfunction as defined by DSM-IV. Patients should have been PDE5 inhibitor respondents

Exclusion Criteria:

* Alpha blockers and Nitrates of any preparation
Retinal Atrophy and Neurofilament Light Chain in People With Multiple Sclerosis Taking Ofatumumab

This study aims to assess whether, and the degree to which, ofatumumab modulates or reduces rates of retinal atrophy in people with relapsing-remitting MS (RMS), according to baseline serum neurofilament light chain (sNfL) levels.

Seventy-five people with RMS who due to commence or already receiving ofatumumab therapy within 60 days of baseline will be recruited. All recruited participants will be tracked prospectively over a two-year period. Participants will complete an optical coherence tomography (OCT) scan, visual acuity (VA) assessments, EDSS, and sNfL blood level at baseline and every 6 months. Participants will be tracked prospectively for 2 years. OCT scans, sNfL levels, disability score determinations, 100% high-contrast, 2.5% and 1.25% low-contrast letter acuities will be performed every 6 months. Results from an existing cohort of approximately 75 healthy controls (HC) from a separate study undergoing annual OCT and visual function assessments will be used for comparison purposes.

Eligibility Criteria:
Inclusion Criteria:

1. Between 18 - 70 years of age
2. Have RMS as confirmed by the treating neurologist based on the 2017 revised McDonald criteria

   AND Either
   * be due to commence ofatumumab within 60 days of baseline OCT/VA/phlebotomy or
   * be existing patients attending the center and already receiving ofatumumab, be eligible for inclusion, and already undergoing all of the proposed study procedures.
3. Willing to sign informed consent
4. Willing to undergo phlebotomy

Exclusion Criteria:

* Uncontrolled Diabetes
* Uncontrolled Hypertension
* Glaucoma
* Refractive errors of +/- 6 diopters
* Other neurologic or ophthalmologic disorders
A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia

This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615 (RN316) in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.


Eligibility Criteria:
Inclusion Criteria:

* Fasting LDL-C greater than or equal to 130 mg/dL at two qualifying screening visits.
* Total body weight greater than or equal to 50 kg (110 lbs) and less than or equal to 150 kg (330 lbs)

Exclusion Criteria:

* Lipid-lowering prescription medications, homeopaths, herbal medicines, or nutritional supplements.
* Poorly controlled type 1 or type 2 diabetes.
* History of a cardiovascular or cerebrovascular event or related procedure during the past year.
* Poorly controlled hypertension.