cyrilzakka/clinical-trials huggingface dataset:
German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms

This PMS study had the objective to evaluate under ordinary medical care conditions the efficacy and tolerability of esomeprazole in patients who where treated by general practitioners and internists.


Eligibility Criteria:
Inclusion Criteria:

* Patients with GERD, or NSAID related ulcers, who need treatment with esomeprazole.

Exclusion Criteria:

* Limitations; possible risks; warnings; contraindications mentioned in the SPC.
High Flavonols Cocoa Intake for the Improvement of Body Fat Composition in Athletes

The decrease in body fat percentage improves exercise performance, reducing race time. The intake of cocoa improves the body fat composition in obese and diabetic people by improving their cardiovascular disease risk factors. Although epidemiological studies indicate that healthy subjects who consume cocoa have lower body fat composition, there is no study indicating whether cocoa improves fat composition in athletes. The aim of the study was to determine if the intake of cocoa rich in flavonoids improves the fat composition of athletes, modifying the systemic levels of adipokines (folistatin, myostatin and leptin), resulting in an improvement of physical performance.

The objective of this project was to investigate the effects of chronic daily consumption of high in flavanols cocoa in body composition and performance of endurance athletes:

A randomized, blinded, parallel placebo controlled intervention study was carried out in endurance athletes . The number of male athletes enrolled in the study was 40, with ages between 18 and 50 years and an aerobic power consumption of oxygen greater than or equal to 55 mL / kg / min). The intervention was carried out for 10 weeks. Cocoa or placebo (maltodextrin) were supplied in sachets of a single daily dose. Cocoa provided 425 mg of flavanols/ day.

Athlete's body composition was evaluated by dual-energy X-ray absorptiometry (DEXA). Exercise performance was evaluated with a treadmill test protocol determining the maximum aerobic capacity and also by determining the time necessary to run a kilometer at maximum speed.

Adipokines (follistatin, myostatin and leptin) in plasma and serum samples were determined by ELISA.

Diet was determined by three 24h-recall questionnaries and a Food Frecuency questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Men.
* Age between 18 and 50 years
* Aerobic power of oxygen consumption greater than or equal to 55 mL / kg / min

Exclusion Criteria:

* Intake of chronical medication.
* Intake any type of nutritional or ergogenic supplements.
* Vegetarian or vegan diet
* Smoke.
* Any diagnosed disease at the time of inclusion or during the study
Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients

Diabetic retinopathy (DR) is a leading cause of vision loss in working age Canadians. Current treatment consists of early detection and laser photocoagulation therapy for preventing progressive or severe vision loss. Microaneurysms (MA) are the earliest, clinically visible changes of DR, which are visualized using specialized imaging technologies. PulseMedica is developing a three-dimensional (3D) retinal imaging system with real-time eye tracking capabilities. The purpose of this study is to assess the feasibility of PulseMedica's prototype device, the OSNAT800 Imaging Only (IO), in providing real-time tracking of eye movements in patients with DR. It is hypothesized that the OSNAT 800 IO will be able to perform real-time eye tracking while imaging patients with DR.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 70 years of age
* Male or female
* Diagnosed diabetic retinopathy
* Two eyes with clear ocular media

Exclusion Criteria:

* Patients younger than 18 years and over 70 years of age
* Patients without diabetic retinopathy
* Opacification of cornea, lens, or vitreous
Dynamics of the Microbiome in the Premature Infant

The purpose of the study is to describe the dynamics of the microbiome in the premature infant as a means to adapt the premature infant gut to affect better health outcomes.

The study team will collect samples of blood and stool from preterm infants once a week from the first week of life until 8 weeks after delivery. Blood samples will be collected from left over blood that is being collected for clinical management. No extra blood draws will be done for research purposes only. Samples of leftover breast milk will be collected once weekly from the first week of life until 8 weeks after delivery.

While the baby is in the hospital the study team will collect information about the growth and development as well as events that happen during their intensive care nursery (ICN) hospitalization.

In addition, blood and stool will be collected, as well as information about the growth when the infant returns to the Duke Special Infant Care Clinic for developmental check-ups at 6 and 12 months of age. The blood will be approximately 1 teaspoon (5 milliliters) and will be done at the same time that labs for clinical management are being done.

A single maternal blood sample (approximately 2 teaspoons) and stool sample will be collected after delivery. Information will also be collected from the medical record.

Eligibility Criteria:
Inclusion Criteria:

* 1500 grams or less at birth
* infants without genetic diseases or gross anomalies
* mother has to be planning on providing breast milk to the infant

Exclusion Criteria:

* infants with genetic diseases or gross anomalies
* parents who are not willing to give consent
Azithromycin for COVID-19 Treatment in Outpatients Nationwide

This individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of COVID-19 in patients with a recent positive SARS-CoV-2 test who are not currently hospitalized.

Identification of a safe, effective treatment for individuals with mild or moderate COVID-19 that prevents disease progression and reduces hospitalization would reduce the burden on the health system. High dose hydroxychloroquine is being evaluated for SARS-CoV-2 prevention and COVID-19 disease treatment, but has a high risk of a number of potentially severe adverse events. Recent evidence has indicated that the broad-spectrum macrolide azithromycin may have some activity against coronaviruses. Here we propose an individually-randomized, placebo-controlled trial to determine the efficacy of a single dose of azithromycin for prevention of COVID-19.

Potential participants will undergo remote eligibility screening with study staff prior to enrollment. Upon determination of eligibility and signing electronic informed consent documents, participants will be emailed baseline study forms and will be mailed their randomized study treatment. At the end of the study (21 days), participants will be emailed a final study questionnaire. Note that there will no contact between study staff and participants in this trial, minimizing risk of infection spread.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of a positive SARS-CoV-2 test and test results received within the previous seven days
* Not currently hospitalized
* Willing and able to receive study drug by mail
* Willing and able to do the study questionnaires at baseline, day 3, 7, 14, 21 days via email or over the phone
* No known allergy or other contraindication to macrolides
* Age 18 years or older at the time of enrollment
* No known history of prolongation of the QT interval (eg. History of torsades de pointes, congenital long QT syndrome, bradyarrhthmia)
* No recent use of hydroxychloroquine within the past 7 days for participants \>55 years of age
* Not currently taking nelfinavir or warfarin (Coumadin)
* Provision of informed consent
* Not currently pregnant
Anastomotic Leak in Covid-19

evaluate the incidence of anastomotic leak after colorectal surgery


Eligibility Criteria:
Inclusion Criteria:

* colorectal cancer

Exclusion Criteria:

* stage 4
Investigation of the Relationship Between Pain Sensitization and Diagnostic Parameters in Carpal Tunnel Syndrome

The aim of this observational, cross-sectional study is to investigate the relationship between pain sensitization and ultrasonographic and nerve conduction studies in patients diagnosed with carpal tunnel syndrome (CTS).

The main questions it aims to answer are:

* Can threshold values be determined ultrasonographically and electrodiagnostically in patients who develop pain sensitization?
* Are pressure pain threshold values and central sensitization inventory scores correlated with ultrasonographic and nerve conduction studies of the median nerve?

Carpal tunnel syndrome (CTS) is the most common nerve entrapment and the main mechanism is compression of the median nerve under the transverse ligament at the wrist level. Its incidence varies between 6.3-11.7% in the general population. In CTS, neuropathic complaints such as numbness, burning and tingling in the palmar face of the first two fingers, which are the innervation area of the median nerve, and fatigue in the hand are the most common symptoms. However, it has been reported that these complaints in most patients are not limited to the innervation area of the median nerve but also spread to other neighboring areas. This has been found to be associated with the development of central sensitization in CTS patients, and extra-median symptoms are suggested to be a clinical marker of pain sensitization. The term central sensitization is explained as an increase in pain sensitivity due to the amplification of neuron-derived signals in the central nervous system.Research shows that ongoing damage to the median nerve stimulates neurons located in the central nervous system, advancing the central sensitization process. Although the diagnosis of CTS is made electrodiagnostically with typical clinical findings, in recent years ultrasound has been frequently used in the diagnosis of CTS because it is non-invasive, fast and reliable. Cross-sectional area and echogenicity of the median nerve are the most frequently evaluated parameters at the carpal tunnel with ultrasound. Studies focus on the clinical relationship of central sensitization in CTS, but its relationship with ultrasonographic and electrodiagnostic data is not yet known.Based on this, this study aimed to investigate the relationship between pain sensitization and electrodiagnostic and ultrasonographic parameters in patients diagnosed with CTS.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with carpal tunnel syndrome based on clinical and electrodiagnostic findings
* Agreeing to participate in the study

Exclusion Criteria:

* Concomitant history of diabetes, systemic inflammatory disease, active infection and malignancy
* Having a disease with neuropathic pain such as polyneuropathy, radiculopathy,multiple sclerosis
* Not agreeing to participate in the study
* History of surgery due to CTS
Methadone Monitoring for Insights Into Adverse Events

Methadone has been an effective and inexpensive therapy in the management of chronic pain and opioid dependence. However it has been associated with sudden, unexpected deaths. Two mechanisms have been suggested, increased drug concentration in the blood, and a change in the heart rhythm. This study will look at blood samples for drug levels and genetic components and EKG's (a noninvasive test which reveals heart rhythm). There will be no intervention.


Eligibility Criteria:
Inclusion Criteria:

* must be 18 years of age or older; eligible for methadone treatment as judged by Discovery House criteria
* must sign informed consent for methadone treatment prior to being approached for this study
* must sign a written informed consent for this study
* is willing and has a means to return for all scheduled follow-up visits

Exclusion Criteria:

* pregnancy, participation in any other clinical trial involving investigational or marketed products with 30 days prior to entry into this study; current use of an inducer/inhibitor of known enzymes involved with methadone metabolism
* use of methadone in the 30 days prior to study enrollment; concomitant use of QT prolonging drugs
* considered by the treatment physician to be ineligible for methadone treatment; hepatic function panel indicates chronic liver disease.
MRI in Assessing Tumor Size in Women With Ductal Carcinoma In Situ

RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and find out how far the disease has spread.

PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women with ductal carcinoma in situ.

OBJECTIVES:

Primary

* Assess the contribution of MRI in accurately determining tumor size in women with ductal breast carcinoma in situ (DCIS).

Secondary

* Evaluate the sensitivity of MRI in detecting DCIS.
* Evaluate the contribution of mammography in accurately determining tumor size.
* Compare the contribution of MRI vs mammography in assessing tumor extension.
* Compare the contribution of MRI vs mammography in assessing dense breasts.
* Evaluate the morphology of DCIS by MRI.
* Evaluate the curve of dynamic MRI in assessing DCIS.
* Evaluate the impact of nuclear grade of DCIS by MRI.
* Evaluate the rate of revision surgery.

OUTLINE: Patients undergo clinical examination, mammography, ultrasound imaging, unilateral breast MRI, and tissue sampling.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of ductal breast carcinoma in situ

  * Any grade disease allowed
* Unifocal disease by mammography
* No history of breast cancer
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* WHO performance status 0-2
* Glomerular filtration rate ≥ 30 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No allergy or contraindication to contrast MRI
* No pacemaker or vascular clip

PRIOR CONCURRENT THERAPY:

* No prior or concurrent liver transplantation
Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

This is a research study of SP-102, an experimental medication designed to relieve pain in patients with a specific type of leg pain. The medication is given once by your healthcare professional, with a possibility of a second injection as early as about 1 month after the first treatment.

The purpose of the study is to measure how well a single injection of the experimental medication, SP-102, relieves pain. The study will also investigate the side effects of SP-102.


Eligibility Criteria:
Main Inclusion Criteria:

* Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures.
* Age 18 to 70 years (inclusive) at the Screening Visit.
* A diagnosis of lumbosacral radicular pain (sciatica).
* Agrees to follow study-specific medication requirements.
* If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study.
* Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures.

Main Exclusion Criteria:

* Has radiologic evidence of a condition that would compromise study outcomes.
* Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while in the study.
* Has been diagnosed with insulin dependent diabetes mellitus.
* Presence of any other disorder, condition or circumstance (including secondary gain) that, in the opinion of the Investigator, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments.
* Use of any investigational drug and/or device within 30 days, or is scheduled to receive an investigational drug other than blinded study drug during this study.
* Has a body mass index ≥40 kg/m2.
The Efficacy of Xuebijing Injection on Sepsis

The Efficacy of Xuebijing Injection in Adult Patients with Sepsis

The purpose of this placebo-controlled study is to determine if Xuebijing Injection treatment provides significant mortality reduction improvement in patients with sepsis compared with placebo treatment in patients receiving the current standard of care for sepsis. This study will also assess the effectiveness of Xuebijing Injection in reducing 28-day mortality in patients with sepsis.

Eligibility Criteria:
Inclusion Criteria:

Patients will be eligible for inclusion if all of the inclusion criteria are met

1. Sepsis-3 criteria from Society of Critical Care Medicine (SCCM) /European Society of Intensive Care Medicine (ESICM)
2. 18≤ age ≤75years
3. 2 ≤SOFA ≤13
4. obtain informed consent

Exclusion Criteria:

1. Diagnosis of sepsis for more than 48 h;
2. Pregnant and lactating women;
3. Severe primary disease including unrespectable tumours, blood diseases and Human Immunodeficiency Virus (HIV);
4. Severe liver and kidney dysfunction (single liver or kidney SOFA score ≥ 3 points);
5. Use of an immunosuppressant or having an organ transplant within the previous 6 months;
6. Participating in other clinical trials in the previous 30 days.
Non-invasive Chromosomal Examination of Trisomy Study

The purpose of this blinded, multi-center, prospective, case-controlled study is to compare the Ariosa Harmony™ Prenatal Test for trisomy 21 detection with a standard first-trimester prenatal screening test consisting of serum screening (PAPP-A,free beta-hCG \[β-hCG\] or total hCG) and a nuchal translucency (NT) measurement (i.e. combined first trimester screening) in a general screened population.

The performance characteristics of these two test modalities will be assessed relative to the clinical reference standard of genetic analysis of the fetus or phenotypic characterization and genetic analysis of the newborn.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old and can provide informed consent.
2. Subject is planning a hospital delivery.
3. Subject has a singleton pregnancy with a documented gestational age between 10 weeks, 0 days, and 14 weeks, 2 days, inclusive, at the time of the study blood sample collection.
4. Subject is planning to undergo combined first trimester prenatal screening that includes NT measurement, and when indicated, serum screening with total or free β-hCG and PAPP-A.

Exclusion Criteria:

1. Subject has known aneuploidy.
2. Subject has active or history of malignancy requiring major surgery and/or systemic chemotherapy.
3. Subject has a twin demise at any gestational age. Twin demise includes any reductions, spontaneous or elective, after sonographic identification of a second (or more) gestational sac. Any clinical, sonographic, or other testing that suggests twin demise would serve as an exclusion criterion.
AI Recognition of Important Structures in Otolaryngological Surgery

Developing a system for artificial intelligence to recognize anatomical landmarks in otolaryngological surgery, enabling real-time tracking of critical temporal bone structures during surgery.

Take the example of the Al recognition and prediction of the incus, external semicircular canal, facial nerve, and facial nerve recess. Within the defined surgical area, annotated data points are utilized to identify and segment the incus and the lateral semicircular canal based on their relative positions and angles concerning the posterior wall of the external auditory canal and the surrounding tissues. Detailed descriptions of the incus and lateral semicircular canal within the surgical area include: Incus: The incus is a small anvil-shaped bone located in the middle ear. It connects to the malleus laterally and the stapes medially. Identifying the incus accurately is crucial due to its proximity to the facial nerve and its involvement in the ossicular chain that transmits sound vibrations. Lateral Semicircular Canal: This is one of the three semicircular canals in the inner ear, oriented horizontally. It is involved in detecting rotational movements of the head. Proper identification is necessary to avoid damaging the canal, which could result in vertigo or balance issues. Input features include further contrast adjustment and localized magnification of images. The enhanced images are classified and localized using the trained model, and the consistency of multiple frames is utilized to determine the final positions of the facial nerve and the facial recess. Statistical analysis is conducted to predict the positions of the facial recess relative to the incus and lateral semicircular canal, providing reference information for surgeons. The system continuously monitors changes in the surgical area, offering dynamic feedback and optimizing the model's accuracy and robustness through incremental training.

Eligibility Criteria:
Inclusion Criteria:

1. Performing otolaryngological surgeries such as cochlear implantation, endolymphatic sac decompression, semicircular canal plugging, and acoustic neuroma surgery using a microscope.
2. Microscopic exposure provides a comprehensive and clear view of the surgical area within the temporal bone.

Exclusion Criteria:

1. No surgical video recording available.
2. Unclear visualization of the surgical area during microscopic otolaryngological procedures.
3. Incomplete visualization of the entire surgical process.
4. Patients who did not undergo high-resolution temporal bone CT at our hospital or Shenzhen Deep Bay Hospital.
Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits

The goal of this clinical trial is to investigate the possibility of rehabilitation of mild cognitive deficits in people with metabolic syndrome. We aim to implement a cognitive training program on patients with metabolic syndrome and cognitive deficits, and examine its effectiveness both post-intervention (3 months) and after 12 months.

Researchers will compare two groups, the experimental group that will receive the computerized cognitive training and the control group that will receive no training.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Presence of metabolic syndrome according to the criteria of IDF (2005) or revised NCEP-ATP III (2005)
* Presence of mild cognitive deficit (-1.5 SD below age and education-adjusted normative mean) in previously administered neuropsychological tests of Trail Making test (Part A \& B), Verbal Fluency test (animals and letter "x"), Logical Memory test (immediate and delayed recall)
* Written informed consent to participate

Exclusion Criteria:

* Presence of any serious neurological or psychiatric condition
Smart Phone Atrial Fibrillation Application

Patients with atrial fibrillation will have the chance to assess their disease management through an application available for free in Android and IOS smart devices


Eligibility Criteria:
Inclusion Criteria:

Paroxysmal or persistent atrial fibrillation

Exclusion Criteria:

unable to provide informed consent unable to have 1 year of follow-up for any reason