cyrilzakka/clinical-trials huggingface dataset:
Three-Dimensional T1rho Using Spiral Fast Spin Echo

Liver fibrosis is the main feature in early chronic liver diseases. If identified early, liver fibrosis is reversible. The current gold standard for diagnosing liver fibrosis is invasive liver biopsy. Existing non-invasive methods still have significant limitations.

T1rho imaging is a promising non-invasive technology evaluating liver fibrosis. It does not require exogenous contrast agent or extra hardware. However, it remains challenging to perform T1rho measurements of the liver. The rich blood signal in the liver introduces quantification errors of liver parenchyma. The existing black blood MRI technologies are based on Cartesian FSE acquisitions, which are not optimal for liver imaging. The residual blood signal is often observed which confounds the measurement. Current T1rho measurement of the liver is mostly performed in two-dimension. 3D coverage of liver is desirable. However, 3D T1rho imaging of liver suffers from long scan time due to increased spatial coverage, reduced scan time efficiency from motion compensation, and high specific absorption rate (SAR).

The investigators aim to overcome these challenges by developing 3D T1rho imaging technologies based on magnetization prepared spiral FSE acquisition. Compared to Cartesian FSE, Spiral FSE traverses k-space more efficiently per unit of time, and has reduced SAR due to significantly decreased number of radiofrequency pulses in the echo trains. Spiral acquisition has zero gradient moment at the kspace center, which substantially reduces its sensitivity to respiratory motion. The residual motion manifests as benign incoherent artifacts in the image domain rather than detrimental structured artifacts. Differently to Cartesian FSE, Spiral FSE provides flexibility to design and optimize flow-sensitizing gradients throughout the echo trains to achieve superior suppression of blood signal. The investigators will evaluate the proposed pulse sequences in both healthy controls and patients with liver fibrosis.

This project will provide new black blood imaging technologies and a 3D diagnostic tool for early detection of liver fibrosis. This will improve clinical outcomes for patients with chronic liver disease, and provide a springboard for further development of MRI technology for other purposes.


Eligibility Criteria:
Inclusion Criteria:

* Between age 18 and age 55
* patients with early liver fibrosis
* Informed written consent obtained

Exclusion Criteria:

* Contraindications to MRI such as the presence of metallic implants, claustrophobia and pregnancy
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 in Healthy Adult Volunteers

This study aims to evaluate the safety and pharmacokinetic characteristics after administration of DWJ1543 in healty adult volunteers.

The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.

Eligibility Criteria:
Inclusion Criteria:

* Over 19 year old
* Healthy adult volunteers

Exclusion Criteria:

* Eye disorders including cataracts
* Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders
TRANSSPINAL DIRECT CURRENT STIMULATION ON FUNCTIONAL MOBILITY IN POST-STROKE PATIENTS

The aim of this clinical trial is to investigate the effects of transspinal direct current stimulation on the functional mobility of post-stroke patients.

The main question it aims to answer is:

Is transspinal direct current stimulation able to improve functional mobility in post-stroke patients?

The researchers will compare transspinal direct current stimulation associated with gait training with sham transspinal direct current stimulation associated with gait training. To verify the effects of stimulation on the functional mobility of post-stroke patients.

Participants:

* They will be assessed before starting the care, after the care has been completed, 15 and 30 days after the care has been completed.
* They will take part in 10 sessions of transspinal direct current stimulation associated with gait training.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ischemic or hemorrhagic stroke, provided by a neurologist.
* Age group greater than or equal to 18 years, of both sexes.
* Any stage of the disease.
* Presence of lower limb sensorimotor disorder related to the stroke
* Absence of cognitive impairment verified through the Mini Mental State Examination (score ≥ 18 for illiterate individuals and ≥ 24 for educated individuals) modified for the Brazilian population.

Exclusion Criteria:

* With other neurological injuries
* With vestibular, visual, cardiovascular or osteomyoarticular disorders of the lower limb that may affect the performance of the proposed tests
* Who have a pacemaker or metallic implants in their spine
Validation of Ultrasound "Angle of Progression" Measurement to Decrease the Cesarean Rate

Ultrasound during labor and measurement of Angle of progression showed extensive prospective and retrospective publications since 2010. The investigators performed between 2013 and 2016 the only one multicenter, randomized controlled Trial comparing digital exam to angle of progression after a prolonged 2-hour second stage of labor with uncertain fetal head. The investigators consider a cut off of 120° to accepted vaginal birth among cephalic occiput anterior position This randomised PILOT study showed that measurement of Angle of progression in addition to digital exam reduced caesarean delivery from 41% to12% ( n= 33, p=0,06). doi: 10.1016/j.ajog.2022.04.018.

The objective of this new study is therefore to validate the results of this PILOT study in a more powerful multicenter randomized trial (DELIVERY).


Eligibility Criteria:
Inclusion Criteria:

* Nulliparous or multiparous women with no history of vaginal delivery,
* \> or = 37 weeks amenorrhoea
* Cephalic presentation in anterior position (occipito-pubic position, left anterior occipito-iliac and right anterior occipito-iliac ) confirmed by ultrasound
* uncertain fetal head engagement on digital examination or midline fetal presentation in prolonged second stage of labor (at least 2 hours),

Exclusion Criteria:

* Multiparous women who were previous vaginal deliveries,
* Presentation other than cephalic,
* Twin pregnancies,
* Posterior or transverse position
* Transperineal ultrasound for head-perineum distance measurement
* Fetal heart rate abnormalities requiring rapid delivery,
* Contraindication to vaginal delivery whether maternal or fetal
Evaluation of Cardiovascular Risk Factors in Incident Dialysis Patients

To evaluate the relationships between bone mineral markers levels at dialysis start and vascular calcification progression during a 2 year follow up


Eligibility Criteria:
Inclusion Criteria:

* Patient who has signed the written consent form
* Patient with chronic renal failure starting dialysis therapy

Exclusion Criteria:

* Pregnancy
* Patient with chronic renal failure not yet on dialysis therapy
Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile

The aim of the study is to assess the beneficial effect of the short term consumption of the highly mineralized bicarbonated sodium water on blood lipid parameters compared to a low mineralized water.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 to 70 years (limits included) ;
* With a BMI between 18,5 (limit excluded) and 35 kg/m² (limit excluded) ;
* Menopausal female without hormone replacement therapy or with stable hormone replacement therapy since at least 3 months or non-menopausal female with reliable contraception since at least two cycles before the beginning of the study and agreeing to keep it during the entire duration of the study;
* Without changes in food habits and physical activity during the last 3 months and agreeing not to change them throughout the study
* Tolerating sparkling mineral water consumption instead of usual water during 8 weeks
* Fasting blood triglycerides level between 1 and 3,5 g/L (limits included);
* Fasting total cholesterol \< 3g/L;
* Fasting blood glucose level \< 1,26 g/L.

Exclusion Criteria:

* Known or suspected food allergy or intolerance to one of the tested products' components or to related products ;
* Consuming more than 2 alcoholic drinks daily;
* Smoking more than 10 cigarettes daily ;
* Following an extreme or exclusive diet (vegetarian, vegan ...)
* With personal history of anorexia nervosa, bulimia or eating disorders;
* With a body weight variation \> 5 kg in the last 3 months;
* Having a lifestyle deemed incompatible with the study according to the investigator;
* With metabolic disorders such as diabetes or other chronic severe disease ;
* Suffering from uncontrolled hypertension;
* With severe chronic disease (cancer, HIV, renal failure, liver disorders ongoing, chronic inflammatory digestive disease, arthritis or other chronic respiratory failure, etc.) or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator ;
* Pregnant or breastfeeding women or intending to become pregnant within 4 months ahead ;
* Under lipid-lowering therapy or stopped for less than 6 weeks for statins or fibrates and less than 6 months for niacin;
* Eating foodstuffs or dietary supplements that may interfere with lipid metabolism (red yeast rice, policosanol, omega-3 fatty acids, plant stanol or sterol) or consuming them steadily over the last 4 weeks;
* Using of medications which could affect lipid absorption or/and metabolism (long-term corticosteroid treatment);
* Using a treatment which may interfere with the evolution of the parameters studied according to the investigator;
* Who made a blood donation in the last 3 months or intending to make it within 4 months ahead ;
* Taking part in an-other clinical trial or being in the exclusion period of a previous clinical trial.

A re-screening can occur from 2 months after the exit of study for failure to comply with the one or more of the eligibility criteria listed above.
Pulmonary Condensate: Non-invasive Evaluation of Pulmonary Involvement in Asthma and Cystic Fibrosis.

Exhaled breath condensate (EBC) represents a rich source for countless biomarkers that can provide valuable information about respiratory as well as systemic diseases. Finding non-invasive methods for early detection of lung injury, inflammation and infectious complications in chronic diseases like (CF) Cystic fibrosis or (AB) Bronchial asthma would be highly beneficial. Investigators propose to establish EBC "breathprints" revealing molecular signatures of pulmonary inflammation and specific respiratory bacterial infections of CF patients and AB. Investigators hypothesize that the analysis of EBC can reveal biomarkers specific for severity of the inflammation, and infection caused by opportunistic pathogens such as P. aeruginosa (PA). With these breath-prints, investigators also propose to establish correlations between respiratory microbiota using traditional methods and CF lung disease severity. Together, the studies will advance the development and validation of EBC as a novel tool for the proper diagnosis of AB and monitoring of CF disease activity, treatment efficacy and PA or another opportunistic infections.

Exhaled breath condensate (EBC) represents a rich source for countless biomarkers that can provide valuable information about respiratory as well as systemic diseases. Finding non-invasive methods for early detection of lung injury, inflammation and infectious complications in chronic diseases like Cystic fibrosis (CF) or Bronchial asthma (AB) would be highly beneficial. Investigators propose to establish EBC "breathprints" revealing molecular signatures of pulmonary inflammation and specific respiratory bacterial infections of CF patients and AB. Investigators hypothesize that the analysis of EBC can reveal biomarkers specific for severity of the inflammation, and infection caused by opportunistic pathogens such as P. aeruginosa (PA). With these breath-prints, investigators also propose to establish correlations between respiratory microbiota using traditional methods and CF lung disease severity. Together, the studies will advance the development and validation of EBC as a novel tool for the proper diagnosis of AB and monitoring of CF disease activity, treatment efficacy and PA or another opportunistic infections.

Eligibility Criteria:
Inclusion Criteria:

* Children/adults with moderate or IgE mediated asthma
* Children/adults with cystic fibrosis
* Healthy control children/adults without lung disorders

Exclusion Criteria:

-
TRACK: Validation of the Portuguese Version

The TRACK ("Test for Respiratory and Asthma Control in Kids") questionnaire is a validated instrument to evaluate the control of respiratory symptoms in young children. The TRACK questionnaire was developed in English and a version in Portuguese is not available or validated, purpose of the present project.

The TRACK ("Test for Respiratory and Asthma Control in Kids") questionnaire is the only instrument developed and validated so far to evaluate the control of respiratory symptoms in young children under five years of age. The TRACK questionnaire consists of five questions, scored from 0 to 20, given to caregivers of children with asthma or recurrent respiratory symptoms, and addresses respiratory symptoms, nocturnal awakenings and limitation of daily activities in the last four weeks, use of bronchodilator medications over the past three months and systemic corticosteroids in the last year.

The TRACK questionnaire was developed in English and has already been translated and validated into Spanish and Arabic. At the moment there is no translation and validation of the TRACK questionnaire for the Portuguese language, purpose of the present project.

Eligibility Criteria:
Inclusion Criteria:

* Native Portuguese speakers families
* Medical diagnosis of asthma or history of at least three episodes of cough and/or wheeze and/or dyspnea (duration longer than 24 hours) and treated with bronchodilators

Exclusion Criteria:

* Other relevant pulmonary diseases (i.e.: cystic fibrosis, bronchopulmonary dysplasia)
* Systemic diseases (i.e.: heart diseases, neurologic disorders)
* Premature birth (under 37 weeks of gestational age)
* Congenital malformations
* Illiteracy and/or inability of parents to understand the questionnaire
Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site

Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.


Eligibility Criteria:
Inclusion Criteria:

* All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.
* Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.

Exclusion Criteria:

* Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).
* Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
* Morbid obesity (BMI \>40).
* Inability to maintain wrist immobilization for full planned period.
* Severe malnutrition (prealbumin levels \<10 mg per dL within 30 days prior to surgery OR BMI \<15 (very severely underweight).
* Other conditions felt to significantly impair wound healing per surgeon discretion
Evaluating HA 0.15% Compared With Cyclosporine 0.05%, and Efficacy of Combination Therapy in Dry Eye Disease Patients

In patients with moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug.

Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 20 or over
* Moderate to Severe Dry Eye Disease Patients
* Written informed consent to participate in the trial

Exclusion Criteria:

* Any laser or ocular surgery within 2 months prior screening
* Use of contact lenses
* Any condition limiting patient's ability to participate in the trial
SILENT SINUS SYNDROME (First Case Report, Saudi Arabia With Recommendation)

Silent sinus syndrome is a rare disorder that presents a diagnostic challenge, most of the patients with this syndrome present with ophthalmological complaints without any nasal sinus symptoms, and it has a painless course and slow development. A case report of a 37-years-old-female who was complaining of severe throbbing pain since 2009, is presented here where the diagnosis of SSS was obtained in 2018, this delay in diagnosing the situation had affected the patient lifestyle tremendously.

Silent sinus syndrome is a rare disorder that presents a diagnostic challenge, most of the patients with this syndrome present with ophthalmological complaints without any nasal sinus symptoms, and it has a painless course and slow development. The syndrome can be diagnosed clinically and confirmed radiologically, and CT imaging is considered the gold standard for its diagnosis. The classical radiographic findings are opacification and collapse of the sinus walls. Functional endoscopic sinus surgery (FESS) is the standard gold treatment of choice to arrest the progression of the disease.

A case report of a 37-years-old-female who was complaining of severe throbbing pain since 2009, is presented here where the diagnosis of SSS was obtained in 2018, this delay in diagnosing the situation had affected the patient lifestyle tremendously.

Accordingly, knowledge of the signs and features of SSS can result in an accurate diagnosis. Suspected cases of silent sinus syndrome require prompt ear, nose, and throat referral for consideration of definitive diagnosis and surgical management. Nasal endoscopy and clinical evaluation are also essential for the diagnosis. Our recommendation is to consider SSS as a differential diagnosis for patients with spontaneous enophthalmos and hypoglobus, even in the absence of maxillary sinus opacification. Moreover, encourage all the specialists in the medical and the dental field to communicate well together in cases like this.

Eligibility Criteria:
Inclusion Criteria:

signs or symptoms in the eyes. signs in the Sinus that seen by X-ray.

Exclusion Criteria:

Children ( \<7 years old)
A Genetic Analysis of Usher Syndrome in Ashkenazi Jews

Hearing loss and loss of vision can be very harmful to the well-being and life of people who suffer from them. Usher syndrome is the name of a disease where people have both hearing loss and visual loss. In fact more than half of people who are deaf and blind have Usher syndrome. In this study we are trying to find the causes of all types of Usher syndrome and to learn more about how the eyes and ears work. Usher syndrome is caused by changes in our genes that lead to mistakes in the functioning of our eyes and ears.

We may conduct hearing tests called audiograms to test hearing and a vision test called an electroretinogram (ERG) to test how well the retina (the part of your eye that senses light) is working on participants in the study. From these tests we can tell what kind of Usher syndrome a participant may have.

We will then get DNA from participants by drawing blood. The DNA will be studied, along with DNA from members of the participant's family and other families, to try to find the gene that is causing Usher syndrome in the participant.

Once the gene is found we will be able to study it to learn more about how the eyes and ears work.

If a subject has already been diagnosed we may just need copies of their medical records and blood can be drawn locally.

In order to increase the power of the study and the likelihood of detecting relevant genes participants will be taken from the Ashkenazi Jewish population group only. This will make it much easier to find the genes.


Eligibility Criteria:
Inclusion criteria:

Any Ashkenazi Jewish individual with combined hearing and visual loss that is or may be any type of Usher syndrome, or a family member of said individual.

Exclusion criteria:

Any individual who is not an Ashkenazi Jew or does not have combined hearing and visual loss or whose disease has been previously determined not to be Usher syndrome.
Age-Related Macular Degeneration (AMD) - Beta Study Telemedicine Assessment

The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients.

This is a non-randomized cohort, multi-center study. The eligible subjects will be asked to use the FORESEE HOME device daily and the tests results will be automatically transmitted to the Data Monitor Center for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who successfully completed participation in ForeseeHome-US2 study
* Patients with ability to comprehend and sign the informed consent/authorization

Exclusion Criteria:

* Subjects who failed to complete participation in ForeseeHome-US2 study
Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

IgA vasculitis is relatively common in children,especially in Asian countries. Abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. Delayed diagnosis could be fatal and cause severe complications.Nowadays no guidelines for those with severe abdominal manifestations in China.However, the most used treatment is steroid. For those severe forms are methylprednisolone pulse, IVIG, immunosuppressants and blood purification. Given the fact that different strategies lead to different endings which varies in cost, adverse effect and clinical outcomes in different medical centers, it is necessary to give birth to a useful and feasible strategy. This clinical trial is a muti-center, randomized,controlled prospective study.Patients with gastrointestinal disease will be recruited in three children's medical centres in Shanghai and will be randomized to two groups: MP group and IVIG group. Cost effect and clinical outcomes will be evaluated. Blood purification will be evaluated as a remedy when MP and IVIG fail to cure.


Eligibility Criteria:
Inclusion Criteria:

1. both genders
2. age between 2-16 years old
3. IgA vasculitis with gastrointestinal involvement
4. course of disease less than 2 months
5. refractory to ordinary dosage of prednisolone (less than 2mg/kg/d）

Exclusion Criteria:

1. patients with severe sepsis
2. patients with central nervous system infection,
3. patients with severe pneumonia
4. patients with chronic infection (such as EBV, CMV, Tuberculosis)
5. patients complicated by CKD who need renal replacement therapy
6. patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy
Phase 2 Study to Evaluate PVX-410 + Pembrolizumab + Chemotherapy for Metastatic, PD-L1+ Triple-Negative Breast Cancer

Evaluating the combination of the investigational, multi-peptide cancer vaccine PVX-410 in combination with pembrolizumab and chemotherapy in treatment naive patients with metastatic, triple negative breast cancer who are PDL1 and HLA A2 positive.


Eligibility Criteria:
Inclusion Criteria:

- HLA A2 Positive PDL1 Positive Treatment naive, triple negative breast cancer

Exclusion Criteria:

-