cyrilzakka/clinical-trials huggingface dataset:
Hb Scope: A Multi-Center Validation Trial

The global prevalence of end-stage renal disease (ESRD) was estimated ranging 5.3 to 9.7 million patients in 2017 and is a major healthcare cost driver in both developed and developing economies. The majority of patients with ESRD, approximately 90%, received in-center maintenance hemodialysis (HD). Although HD patients are under the close supervision of a nephrologist, they are vulnerable to anemia and substantial hemoglobin (Hb) variability, which are controversially associated with poor clinical outcomes, such as all-cause mortality. The contemporary narrow target hemoglobin level recommended in the KDIGO and KDOQI guidelines, despite the ongoing debates, poses a crucial challenge in maintaining the optimal hemoglobin level in HD patients.

The Big Data Center at China Medical University Hospital (CMUH) has developed a tool, Hb Scope APP, that can use the color of the HD tubing to predict real-time Hb levels by leveraging the smartphone's camera capacity and machine learning (ML) technology. The performance of the Hb Scope ML algorithm in predicting Hb \> 10 g/dL can reach an accuracy of 0.93 and an AUROC of 0.99 in the testing dataset. This opens an opportunity to establish a vibrant digital ecosystem for automatic anemia management.

Innovative ML tools must be appropriately regulated before these algorithms are adopted into clinical practice. Therefore, in the current validation study, we propose to do a multicenter validation trial for validating whether the Hb predicted by Hb Scope APP can achieve an area under the receiver operating curve (AUROC) of at least 0.80 in the adult HD populations from CMUH, Asia University Hospital (AUH) in Taiwan, and SEHA Kidney Care (SKC)-Central in the United Arab Emirates.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving regular maintenance HD in the three participating sites; AND
* Aged 20-90 years old; AND
* Received regular HD through an arteriovenous (AV) fistula or AV graft access; AND
* Use the Fresenius HD machine 4008/4008S and 5008/5008S.

Exclusion Criteria:

* Do not have last Hb level from labs within 1 month prior; OR
* Do not receive blood drawn for the true Hb level or do not have the true Hb level on the date of image taking by Hb Scope APP; OR
* Do not agree to participate.
Radiation Therapy With Androgen Suppression in Treating Patients With Prostate Cancer

RATIONALE: Imaging procedures such as MRI may improve the ability to determine the response of prostate tumors to therapy.

PURPOSE: Phase II trial to study MRI results in patients with prostate cancer that has been treated with radiation therapy plus androgen suppression therapy.

OBJECTIVES: I. Establish whether changes between baseline and 2-month post androgen suppression endorectal coil MRI results predict for biochemical control following radiotherapy with androgen suppression in patients with adenocarcinoma of the prostate.

OUTLINE: Patients undergo a baseline endorectal coil MRI, followed by total androgen suppression (TAS) with either leuprolide IM or subcutaneous goserelin once a month plus oral flutamide 3 times a day for 2 months. Patients then receive a second endorectal coil MRI, followed by 2 months of external-beam radiotherapy plus TAS. Patients may receive an additional 2 months of TAS at the discretion of the treating physician. Patients are followed every 6 months for 3 years, then yearly thereafter.

PROJECTED ACCRUAL: Approximately 180 patients (approximately 60 per year) will be accrued for this study over a 34 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate AJCC stage T1b-T4b, N0 or Nx, M0 Transrectal, transperineal, or transurethral biopsy required

PATIENT CHARACTERISTICS: Age: 30 and over Performance status: CALGB 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: The following may increase the risk of protocol treatment: Serious intercurrent medical illness that might compromise patient safety Active acute infection requiring antibiotics Suppression therapy for chronic urinary tract infection allowed Uncontrolled or severe cardiovascular disease Psychiatric conditions that prevent compliance or informed consent

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for carcinoma of the prostate Endocrine therapy: No prior androgen deprivation therapy (medical or surgical) Radiotherapy: No prior radiation therapy for carcinoma of the prostate Surgery: No prior surgical androgen deprivation therapy
Study of Accuracy of New Diagnostic Technology to Determine Guide Rapid Antibiotic Treatment for Serious Infections

Military service members and the U.S. veteran population face a growing and serious health threat: widespread antibiotic resistance resulting from resistant bacteria and a dwindling pipe-line of sufficiently potent antibiotics. Infections with antibiotic resistant bacteria are increasing significantly. They cause major complications and mortality, and drive up healthcare costs. Powerful but non-targeted antibiotics, while in widespread use, can actually pressure bacteria to develop resistance.

Current methods for diagnosing infections typically require 2-3 days to produce results that can guide antibiotic choice. That is frequently too delayed to help clinicians make good treatment decisions. This also results in inappropriate or over-treatment with non-targeted antibiotics that are started while awaiting lab results. More rapid technologies that can accurately diagnose the specific cause of an infection could guide early, targeted antibiotic treatment. This would result in more effective early treatment of infection, decrease unnecessary exposure to excess antibiotics, and could slow the development of antibiotic resistance. By diagnosing infections earlier, we expect to reduce the complications and mortality of combat-related infections in Wounded Warriors and Military Veterans.

We propose a new ultra-rapid technology (called MADM) that uses a digital microscope to detect bacteria growing directly from a patient's specimen, rather than waiting for growth in lab cultures. The innovative new method supports identification of the infecting bacteria within 2 hours of receiving a specimen. The technology also shows the effect of selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors know within 6 hours from specimen collection which antibiotic kills the bacteria.

This study involves collection of any excess volume of microbiology specimens after it has been determined sufficient sample is available for clinical care. All microbiological samples and results are being obtained for solely non-research purposes as part of usual care; only leftover/discarded materials from clinical or research procedures already performed will be used for this study. Samples will be tested in tandem with usual care on the new technology to test the accuracy and speed. Results obtained from the new technology will not be used in patient care or to make treatment decisions.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Microbiology culture (respiratory, blood or tissue/skin) ordered during regular clinical care.

Exclusion Criteria:

* Insufficient sample volume available after clinical test completed.
Pelvic Girdle Pain Early Postpartum: Underlying Condition and Associated Factors

Background: Pregnancy-related pelvic girdle pain (PGP) can appear during pregnancy, directly after labour or can be delayed to 3 weeks postpartum. Pain is experienced between the posterior iliac crest and the gluteal fold, particularly in the vicinity of the Sacroiliac joints (SIJ). The pain may radiate in the posterior thigh and can also occur in conjunction with/or separately in the symphysis. The endurance capacity for standing, walking, and sitting is diminished. The diagnosis of PGP can be reached after exclusion of lumbar causes. The pain or functional disturbances in relation to PGP must be reproducible by specific clinical tests. Lack of accurate and early diagnosis of the PGP reasons postpartum may contribute to development of chronic condition, lowering quality of life years after delivery.

Objectives: The aim of the project is to evaluate the underlying cause of the severe pelvic girdle pain postpartum (whether it is real PGP or diastasis pubic symphysis) and to assess the differences between females with severe postpartum PGP, mild and moderate PGP and with no PGP in terms of: presence of diastasis pubic symphysis, presence of diastasis recti and linea alba dysfunction, factors associated with labour and maladaptive mental processing (catastrophizing).

Materials and methods: Because of low incidence of researched conditions, a case control study will be the study design of choice. The subjects with PGP will be matched with those with no PGP. Subjects' assessment will consist of palpation and ultrasonography evaluation of diastasis recti(inter-recti distance), ultrasonography assesment of pubic symphysis (inter-pubic width) and mental processing (catastrophizing assessed with Pain Catastrophizing Scale) analysis. Factors connected with labour (time from epidural anaesthesia injection to full dilatation and delivery) will be also investigated.

Expected results: To the investigators' knowledge, postpartum pelvic girdle pain has not been extensively studied so far. The study will bring information about the possible underlying cause of postpartum PGP: whether it is PGP or diastasis pubic symphysis.


Eligibility Criteria:
Inclusion Criteria:

* Natural labour or vacuum extractor or forceps
* for the study group - pain due to PGP confirmed with dedicated functional tests
* for control group with no pain - no pain due to PGP
* agreement to participate

Exclusion Criteria:

* diseases that can mimic PGP f.ex. Scheuermann disease, rheumatoid arthritis, Ehler's-Danlos Syndrome, hip dysplasia
* major peri-partum events like internal haemorrhage, pelvic fracture
The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study

This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)


Eligibility Criteria:
Inclusion Criteria Normal Anterior Segment

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. Eye(s) with normal anterior segment

Exclusion Criteria Normal Anterior Segment

1. Active infection or inflammation in the study eye
2. Insufficient tear film or corneal reflex
3. Physical inability to be properly positioned at the study devices or eye exam equipment
4. Rigid contact lens wear 2 weeks prior to imaging
5. Soft lenses worn within one hour prior to imaging
6. Cataract grade ≥1.5

Inclusion Criteria Abnormal Anterior Segment

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. Eye(s) with abnormal anterior segment (including cataract grade ≥ 1.5)

Exclusion Criteria Abnormal Anterior Segment

1. Active infection or inflammation in the study eye
2. Insufficient tear film or corneal reflex
3. Physical inability to be properly positioned at the study devices or eye exam equipment
4. Rigid contact lens wear 2 weeks prior to imaging
5. Soft lenses worn within one hour prior to imaging
Urine Biomarkers to Predict Acute Kidney Injury After Pediatric Cardiac Surgery

The goal of this prospective cohort study is to evaluate, in pediatric patients after cardiac surgery, the predicting capability of biomarkers for acute kidney injury. The main questions it aims to answer:

* The predicting capability of acute kidney injury (AKI) biomarkers for the primary endpoint: the occurrence of AKI stage ≥ 1 within 48-h after intensive care unit (ICU) admission.
* The predicting capability of AKI biomarkers for the secondary endpoint: the occurrence of AKI stage ≥ 2 within 12-h after ICU admission.
* Investigated biomarkers include urine chitinase 3-like protein 1 (uCHI3L1), urine neutrophil gelatinase-associated lipocalin (uNGAL), tissue inhibitor of metalloproteinases-2 (TIMP-2), insulin-like growth factor-binding protein 7(IGFBP7), NephroCheck® and Δ serum creatinine \[postop-preop\]. Differences in concentration between patients with and without AKI development were investigated, as well as AKI diagnostic performance of (combined) biomarkers.

During and after cardiac surgery several blood and urine samples will be taken of participants to investigated AKI occurrence and to measure biomarker concentrations.

Pediatric patients after cardiac surgery were prospectively included. Urine and blood samples were taken between induction of anesthesia and the start of cardiac surgery, at intensive care unit (ICU) admission and 2, 4, 6, 12, 24, 48-h after ICU admission respectively.

Sampling was only done in the operating room and ICU. Volume and number of blood samples collected were according to the guidance of the European Commission on blood volume limits for sampling. Clinical data were extracted from the hospital records by study coordinators. Samples were anonymized as were clinical data. All technicians were blinded to clinical data.

Acute kidney injury was defined by the Kidney Disease Improving Global Outcomes (KDIGO) definition and classification, using both serum creatine as urine output criteria. AKI predicting capability of biomarkers was assessed by performing area under the receiver-operating characteristics curve (AUROC) analysis. Biomarkers were evaluated individual and as a combination of two- or three-biomarker-panels diagnostic tests. Additionally, the absolute difference between pre- and postoperative serum creatinine (ΔsCr\[postop-preop\]) was evaluated as diagnostic test.

To correct for urine dilution, the investigated urine biomarkers were normalized, by dividing urine biomarker concentration by urine creatinine concentration.

A sensitivity analysis was made to evaluate the biomarker performance to predict AKI ≥ 1 in patients who did not already have AKI ≥ 1 at ICU admission. Likewise, a similar sensitivity analysis was made for AKI ≥ 2.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients (age \<18 years with body weight ≥ 2 kg)
* patient underwent elective cardiac surgery

Exclusion Criteria:

* AKI stage ≥1 on admission
* chronic kidney disease (CKD) stage 5
* kidney transplantation
* cardiac surgery during weekend
China REgistry of WATCHMAN

This registry is designed to observe the safety and effectiveness of WATCHMAN left atrial appendage closure technology in a Chinese population.

In this prospective, multi-center, single arm observational study, 413 patients with non-valvular atrial fibrillation intended to be implanted with a WATCHMAN device based on real clinical practice will be enrolled. Enrolled subjects will be followed up for 5 years.Primary endpoints include stroke, systematic embolism, cardiovascular death, and procedure or device related complications, etc.

Eligibility Criteria:
Inclusion Criteria:

Non-valvular atrial fibrillation patient with CHA2DS2-VASC≥2, and with any one of the following items:

1. not suitable for long-term anti-coagulation therapy;
2. stroke or embolism events in spite of warfarin treatment with intended INR
3. HAS-BLED≥3

Exclusion Criteria:

Patient with any one of the following items will be excluded from the study:

1. clinical exclusion criteria (any of the items) a congestive heart failure NYHA IV, b atrial septum defect, ASD surgery or closure c cardioversion or catheter ablation is planned within 30 days d with mechanic valve e left atrial appendage resection f heart transplantation g symptomatic jugular artery disease h previous stroke or TIA within 30 days i long term warfarin therapy is needed or contraindicated to warfarin j contraindicated to aspirin or clopidogrel k enrolled in other cardiac device or medicine trials l pregnant women or plan to pregnant during the study period m estimated life \< 5 years

2 Echocardiography exclusion criteria (any of the items) a LVEF\<30% b thrombus or spontaneous echo imaging detected within two days prior to procedure c patent foramen ovale d cardiac tumor e left atrial appendage orifice diameter \>32mm or \< 17mm f the depth of left atrial appendage is less than the width g prominent mitral stenosis (area \<1.5cm2)

3 subject is not able to or will not complete the follow ups as planned
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry

The recent data suggest that cancer cells at the origin of prostate cancer metastases can be detected in an early stage. Available techniques allow phenotypic analysis of cancer cells in circulating blood (cellsearch) or in marrow hematopoietic (flow cytometry). Pilot study on 180 patients infected by prostate cancer at all stage of disease, show that c-met marker , integrin alpha 2 and 6 expressed in marrow and quantified by flow cytometry were predictor of metastatic progress. In this new study the investigators will analyze antibody panel by cellsearch and flow cytometry on marrow sample of castration-Resistant prostate cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma or prostate
* Ongoing effective androgen deprivation therapy (testosterone ≤ 50 ng/mL)
* Castration-Resistant prostate cancer patient : defined as a minimum of 3 rising PSA values assessed and/or radiological progress confirmed by RECIST and PCWG2
* Patient who signed informed consent

Exclusion Criteria:

* Severe disorders of coagulation
* Major skin lesion on iliac crests
* Allergies in local anesthetics
* Psychological instability or psychiatric histories
* Uncertain follow-up and distant residence
* History of another invasive cancer and hematologic disease
* Patient deprived of their freedom by court or administrative order
* Revocation of consent
Navigation Laser Versus Traditional Laser Photocoagulation for Mild Diabetic Macular Edema

The aim of this study is to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser.

navigation laser is a novel fundus imaging and laser treatment method that allows imaging (infrared, colour, fluorescein angiography) and integrated laser treatment of the retina. Besides documentation, precision,safety and patient comfort,the main theoretical advantages lie in retina navigation.This randomized, parallel controlled, clinical-trial aims to evaluate treatment effect and safety of navigation laser photocoagulation for mild diabetic macular edema compared with traditional laser. The primary outcome measures is the Best-corrected visual acuity (BCVA) of the participants at 1 year after treatment. Besides, the slit-lamp examination, tonometry, funduscopy, and OCT, FFA, ICGA examinations will also be compared between different groups to find the advantage of navigation laser .

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Diagnosed as diabetic retinopathy with Mild macular edema
* BCVA≥0.5
* No macular laser coagulation or surgery or medicine therapy of macular edema within the last 6 months

Exclusion Criteria:

* Blood glucose was not controlled steadily(HbA1cd≥10%)
* Accompanied with severe hypertension（BP≥180/110mmHg）
* Taking part in other clinical trial within 3 months
* Planning panretinal photocoagulation(PRP) within 3 months
* Performed cataract surgery in the last 3 months
* Accompanied with other retinal vascular disease that can lead to macular edema, for example branch retinal vein occlusion(BRVO),central retinal vein occlusion(CRVO)
* Accompanied with severe opacity of refractive media that maybe impact therapy and observation
* Accompanied with nystagmus
* Accompanied with some history that maybe interfere with result or increase the risk of patients
Follicle Activation by Inhibition of the Hippo Pathway

The aim of this project is to activate recruitment and growth of resting primordial follicles in the ovaries of women with diminished ovarian reserve, in attempt to increase the chance to become pregnant, either naturally or after assisted reproduction.

For this study investigators will carefully select 20 women with low AMH and imminent POI.

They will be randomized to have cortical ovarian biopsies taken from either the left or right ovary. The biopsies will be fragmented in 1x1 mm2 pieces and immediately auto-transplanted in a peritoneal pocket under the right ovary.

The contralateral untouched ovary will act as the control, making each woman their own control.

Follow up: each week in 2,5 months the women will be assessed by transvaginal ultrasound and hormonal status. After 2,5-6 months the women will receive a FSH stimulation cycle (rFSH 300 IU or Corifollitropin) followed by standard IVF/ICSI,

Hypothesis: the ovaries contain a pool of resting primordial follicles. By fragmentation of cortical ovarian tissue, manipulation of the local environment in the tissue will inhibit the Hippo Pathway and hereby active recruitment and growth of primordial follicles.

Eligibility Criteria:
Inclusion Criteria:

* Infertility with indication for IVF/ICSI
* Imminent POI, still cycling
* Age 25 - 39 years
* Two ovaries
* Serum AMH measurements \< 5 pmol/l (two independent measurements)
* Antral follicle count (AFC) (sum of both ovaries \< 5)

Exclusion Criteria:

* Ovarian pathology (endometriosis, cysts)
* Known chromosomal abnormality
* Known autoimmune disease (except TPO-antibodies)
* Patients who have contraindication for laparoscopy
Motivating Value of Vegetables Study

The purpose of this study is to see if perceived barriers to vegetable consumption can be overcome by making it easier for people eat more vegetables and to see if the effects last over time.

High vegetable consumption is associated with maintenance of a healthy body weight. Americans do not eat vegetables in the amounts recommended by the dietary guidelines and interventions to increase intake have had limited results. Reported barriers to consumption include not knowing how to prepare them and being unused to eating them.To get people to eat vegetables, they have to be motivated to do so. Repeated consumption of snack foods increases overweight and obese individuals' motivation to eat snack foods. The investigators hypothesize that by increasing people's consumption of vegetables by making them easy to eat will increase the motivation value of vegetables. For this study the investigators propose to provide minimally-processed (cleaned, packaged) vegetables to overweight and obese individuals. The motivating value of vegetables will be measured using a computer task where people play a game to earn points towards portions of a vegetable or a neutral food (crackers). The investigators will determine potential moderators of the increase in the motivating value of vegetables such as genetics (single nucleotide polymorphisms) that are associated with the motivating value of food and whether people substitute eating vegetables for other foods. The investigators will also determine changes in adiposity as a result of vegetable consumption. Lastly, the investigators will determine if repeated consumption increases psychosocial predictors of vegetable intake, such as self-efficacy of eating vegetables.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 25 kg/m2
* Currently eating ≤ 1 cup of vegetables (apart from fried potatoes) per day
* Willing to consent to study conditions

Exclusion Criteria:

* BMI \< 25 kg/m2
* Age \< 18 years or \> 65 years
* Currently dieting or following specific diet
* Allergies or unwillingness to consume study foods
* Gastrointestinal disorder or disease
* Pregnant, lactating, or planning pregnancy
* Current smoker or tobacco user
* High dietary restraint or certain eating patterns
* Inability to give consent
* Medications that would influence appetite, weight gain, or weight loss
* Exclusionary medications: Didrex, Tenuate, Belviq, Contrave, Phendimetrazine, Adipex-P, Suprenza, Xenical, Qsymia, Saxenda