cyrilzakka/clinical-trials huggingface dataset:
Technological Development and Clinical Parallel Testing of PGT-G

Preimplantation genetic testing (PGT) has three different testings according to the type of genetic disease, which was classified as PGT-M, PGT-SR and PGT-A. If the couple is tested for two different genetic diseases at the same time, it is necessary to customize the probe and adopt different detection methods, which increases the cost and cycle of testing. Advanced expert pre-experimental analysis is required for PGT-M in couples with monogenic disease. If the family members are unavailable, only the polar bodies, sperms or affected embryos can be used to analysis, which not only increases the risk of failure, but also increases the difficulty of detection. At present, BGI has developed a new single-tube complete Long fragment whole genome sequencing (stLFR-WGS) technology, which uses the same molecular tag on the short read sequencing fragments from the same long DNA molecule to achieve accurate short read sequencing to obtain long DNA information. Multiple genetic abnormalities such as gene variation, chromosome aneuploidy and chromosome structure rearrangement can be directly detected in embryos without pre-experiment of family members, so as to achieve universal normalization of the three PGT methods and solve the PGT detection needs of patients with multiple genetic diseases.


Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing PGT cycle;
2. Patients with balanced chromosomal structural rearrangement (reciprocal translocation, Robertsonian translocation, inversion, etc.) by conventional karyotype analysis;
3. Clearly diagnosed monogenic genetic disease, and the related genes and their mutations are judged to be pathogenic or likely pathogenic;
4. Chromosomal abnormalities in recurrent abortion tissues or in PGT-A embryos; The number of blastocysts was \>= 1, and the morphological classification was more than 4BC/4CB.

Exclusion Criteria:

1. Belonged to any contraindications of PGT;
2. Failed to embryo biopsy;
3. Failed to embryo WGA failure or abnormal quality control;
4. Failed to embryo sequencing, and the result was unknown.
Effects of Spirulina on Cardiac Functions in Children With Beta Thalassemia Major

The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.

The aim of this study is to evaluate the cardioprotective effect of spirulina in children with beta thalassemia.

this study will be carried on thirty children with beta thalassemia major from those attending the Hematology Unit of Pediatric department at Tanta University Hospital, and another thirty healthy children of matched age and sex will be enrolled as controls.

all studied children will be subjected to careful history taking and through clinical examination. laboratory investigations will be done including complete blood count, hemoglobin electrophoresis, serum ferritin, liver and kidney functions, and troponin-1 plasma level. echocardiographic assessment of the cardiac functions will be done for all patients. Source data will be the patients medical records.

oral spirulina will be given for studied patients for 3 months, and clinical examination, laboratory investigations and cardiac functions will be assessed at the time of inclusion in the study, and again after 3 months of regular spirulina supplementation.

An informed consent will be obtained from parents of all included subjects. the results of this study will be tabulated and statistically analyzed using Statistical Package for the Social Sciences (SPSS).

Eligibility Criteria:
Inclusion Criteria:

* children suffering from beta thalassemia major with age range from 4-18 years

Exclusion Criteria:

* children with congenital heart diseases children with rheumatic heart diseases presence of heart failure children with coronary arterial disease children with cardiomyopathy
A Program of Physician Supervision to Improve the Quality of Patient Referrals From Nurse Practitioners and Physician Assistants

The investigators have previously demonstrated utilizing a validated tool, that the quality of referrals from nurse practitioners (NP) and physician assistants (PA) is less than referrals from physicians. The investigators hypothesize that with local physician input, the quality of referrals from nurse practitioners and physician assistants will improve. This is a prospective study comparing patient referrals from nurse practitioners and physician assistants with and without prior discussion with a local physician.


Eligibility Criteria:
All nurse practitioners and physician assistants in the Mayo Clinic Health System
Effectiveness of an EHR Interface to Reduce Dosage of Hydroxychloroquine

Hydroxychloroquine (HCQ) is a disease-modifying, anti-rheumatic drug that regulates immune system activity and is typically prescribed to treat rheumatoid arthritis and systemic lupus erythematosus, as well as other immune conditions. Although generally well tolerated, study data have demonstrated that long-term use of HCQ may lead to irreversible and potentially vision-threatening retinal toxicity. The American Academy of Ophthalmology (AAO) issued guidelines in 2011, and again in 2016 that recommended dosing of HCQ be based on an individual's body weight, and also outlined how and when to screen for retinal toxicity. While clinicians have been aware of the potential side effects of HCQ for decades, studies have shown that many patients continue to receive higher than recommended doses.

The goal of this study is to conduct a pragmatic trial to assess the utility of a new e-prescribing (eRX) interface for prescriptions of hydroxychloroquine (HCQ). The investigators will measure the effectiveness of the system in reducing the number of individuals prescribed HCQ over current guidelines by randomizing clinicians to the new interface. Ideally, the eRX interface will result in a lower number of potential adverse events (i.e. retinal toxicity) associated with high-dose, long-term use of HCQ.


Eligibility Criteria:
Inclusion Criteria:

* All providers that prescribed hydroxychloroquine in the year previous to the intervention start date in rheumatology and dermatology clinics

Exclusion Criteria:

* Inactive providers in rheumatology and dermatology clinics
Japanese Idiopathic Interstitial Pneumonias Registry

An objective of JIPS Registry is to examine disease behavior of idiopathic interstitial pneumonias (IIPs), considering classification, background, and diagnostic methods based on American Thoracic Society (ATS)/ European Respiratory Society(ERS) /Japanese Respiratory Society (JRS)/ Latin American Thoracic Association (ALAT) guidelines for diagnosis and the ATS/ERS classification of 2002 and 2013.

JIPS Registry is a multi-site, non-interventional, prospective observation study of patients with newly diagnosed IIPs in Japan. At least 600 patients will be registered for 16 months at approximately 80 sites in Japan.

Primary research question is to determine the natural history of each category of IIPs at registration, patient background and diagnosis methods will be considered. Furthermore, the present treatment patterns and disease behavior (CT and forced vital capacity (FVC) changes, as well as changes in interstitial pneumonia markers, etc.) will also be investigated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged between 20 and 84 years
2. Patients with idiopathic pulmonary fibrosis (IPF) and other IIPs diagnosis within 6 months before registration at each facility
3. Patients from whom written informed consent has been obtained regarding participation in this study and follow-up observation

Exclusion Criteria:

1. Patients for whom the tests (such as the lung function test) conducted in this study could not be performed
2. Patients who underwent pulmonary resection
3. Patients undergoing dialysis
4. Patients with cancer treated at the time of registration or those planning to receive treatment in the future
Derma Pen as Treatment of Gingivitis Induced by Orthodontics

Although orthodontic therapy frequently improves tooth alignment and appearance, its problems with oral hygiene can make patients highly susceptible to gingivitis. After orthodontic treatment, gingivitis is a typical problem. New treatments that promote healing and decrease inflammation are needed. Ascorbic acid and Derma Pen used together have recently surfaced as a potentially effective therapy option for patients who seeking for periodontal therapy during and after orthodontic treatments.


Eligibility Criteria:
Inclusion Criteria:

1. patients age: 18-25 years .
2. systemically healthy patients.
3. mild to moderate plaque-induced gingivitis patients during orthodontic therapy

Exclusion Criteria:

1. periodontitis.
2. individuals who smoke or those who have tobacco related habits.
3. partially edentulous individuals.
4. individuals who are diagnosed with drug-induced gingival enlargement.
5. Pregnant or lactating women
Multi-delay Arterial Spin Labeling Application in Acute Ischemic Stroke

This study explores the value of the non-invasive quantitative evaluation system for cerebral blood flow perfusion function in the diagnosis of stroke. Compared with traditional perfusion techniques, multi-delay arterial spin labeling (ASL) is validated to determine the accuracy of perfusion level, ischemic penumbra and other indexes in patients with acute ischemic stroke. The relationship between perfusion levels of mD-ASL parameters and clinical outcome is also studied.

A total of 200 patients with acute anterior circulation ischemic stroke will be prospectively enrolled.

All patients underwent CTP, multi-delay ASL, DWI, CTA or TOF-MRA scanning. CBF, CBV, MTT and Tmax will be obtained based on CTP, and the range of reversible cerebral ischemia injury will be calculated based on DWI and CTP data. CBF, CBV and ATT images will be obtained based on the multi-delay ASL, and the calculated results of reversible cerebral ischemia injury will also be obtained.

Meanwhile, the image quality of CTP and multi-delay ASL will be evaluated. The time from the patient to the completion of imaging examination and the imaging examination time will be recorded.

Mann-whitney U test and T test can be used to compare the difference of assessment time between different test methods. Chi-square test can be used to compare the differences of image quality among different examination methods. Wilcoxon rank sum test can be used to evaluate the difference between CTP and Multi-delay ASL in terms of parameters and volume of reversible ischemic injury.

Eligibility Criteria:
Inclusion Criteria:

1. Ischemic stroke within 24h；
2. Anterior circulation occlusion confirmed by conventional angiography or magnetic resonance angiography；

Exclusion Criteria:

1. Pregnancy and other contraindication to MRI scan；
2. Informed consent not obtained.
Registry of Congenital Dyserythropoietic Anemia

Congenital dyserythropoietic anemia is a heterogeneous inherited disease. Hyperplasic erythropoiesis is ineffective and associated with morphological abnormalities of some of the erythroblasts that form the basis of cytological classification. The cumulative incidence is not very clear, but varies between countries from 0.08 million in Scandinavia to 2.6 cases/million inhabitants in Italy where it appears to be the most reported.

The common manifestation is moderate chronic congenital anemia. This anaemia is either normocytic or discreetly macrocytic, non-regenerative or inappropriate regarding anaemia, contrasting with signs of hemolysis with moderate unconjugated hyperbilirubinemia. Diagnosis is usually made in the pediatric period, but because of the great heterogeneity, the diagnosis sometimes may be delayed. Splenomegaly and jaundice are mostly present. Secondary hemochromatosis is common in the absence of transfusion due to hyper-intestinal absorption of iron induced by the dyserythropoiesis.

The transmission mode for Type I and II is autosomal recessive, while it is autosomal dominant or sporadic for Type III.

Several clinical questions remain concerning this disease :

* the median survival of patients is not well known, neither the causes of death
* benefit/risk of splenectomy
* iron overload quantification and consequences

The idea is to stablish a French registry of congenital dyserythropoietic anemia in order to help to understand the correlation between phenotype and genotype of this disease.


Eligibility Criteria:
Inclusion Criteria:

* Patient with confirmed CDA
* No opposition to the use of health data for research purposes

Exclusion Criteria:

* Patient opposed to participate in the study
A Novel Vaccine for the Treatment of MUC1-expressing Tumor Malignancies

Rationale:

ImMucin was shown to be able to induce a robust cellular immune response mediated via both CD4+ and CD8+ T lymphocytes and therefore, could potentially be more effective in the majority of the target population.

Purpose:

The purpose of this study is to evaluate the safety and initial efficacy of ImMucin, a novel peptide vaccine in metastatic tumors expressing the MUC-1 Tumor Associated Antigen (TAA).


Eligibility Criteria:
Inclusion Criteria:

* All patients must have a histological or cytological diagnosis of metastatic disease expressing the MUC-1. Patients must have metastatic disease and have failed at least one regimen of standard based chemotherapy for metastatic disease such as:

  * Renal Cell Carcinoma (RCC),
  * Transitional Cell Carcinoma (TCC),
  * Prostate,
  * Breast,
  * Ovary,
  * Non-small cell lung,
  * Colon,
  * Multiple myeloma and
  * Pancreatic.
* Patients must be \>18 years of age, consenting to participation in the study.
* Patients must have at least one site of measurable tumor or measurable tumor marker.

Exclusion Criteria:

* Patients receiving any immunosuppressive treatment that could negate development of an effective immune response to the vaccine.
* Subjects with prior irradiation to a field that includes more than 25% of their lymph nodes and bone marrow likely to be immunosuppressed will be excluded. However, patients who had standard pelvic field radiation such as adjuvant therapy for rectal cancer are not excluded.
* Pregnant and breast feeding women will be excluded. Premenopausal women who are not practicing or willing to practice adequate birth control methods for a period of 3 months after treatment will be excluded.
* Patients with brain metastases.
* Patients with active infection.
* Patients with HIV hepatitis B surface antigen (HBS Ag) and hepatitis C virus (HCV) positive patients.
Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.

Speaking valve seems to have a beneficial influence on breathing and secretion management in certain patients with tracheostomy.

The investigators plan to use a speaking valve during respiratory physical therapy sessions in participants with disturbances of consciousness, who have a tracheostomy, with no need of a mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* brain injury (traumatic/non-traumatic).
* tracheostomy.
* unresponsive wakefulness syndrome or minimally conscious state.
* fiber optic examination as follows: good mobilization of the vocal cords. No airway granulation, MarianJoy scale score: 1-3.
* the legal guardian speaks Hebrew.

Exclusion Criteria:

* airway stenosis / inflammation.
* oxygen saturation \<90%.
Integrated Treatment for Posttraumatic Stress Disorder and Substance Abuse in Young Adults

The purpose of the study is to determine the safety and efficacy of an integrated treatment for substance abuse and posttraumatic stress disorder for young adults. The integrated treatment includes two established psychosocial treatments for substance abuse (Contingency Management) and posttraumatic stress disorder (Prolonged Exposure therapy).


Eligibility Criteria:
Inclusion Criteria:

* 18-25 years old
* meets diagnostic criteria for substance use disorder
* meets diagnostic criteria for full or subthreshold posttraumatic stress disorder
* currently able to provide a urine drug screen that is negative for cocaine, prescription opiates, and non-prescribed methadone or provided this type of screen in the past 60 days
* speaks English

Exclusion Criteria:

* significant cognitive impairment or serious uncontrolled psychiatric problem (other than posttraumatic stress disorder)
* in recovery from pathological gambling or current pathological gambling diagnosis
* in a current domestic violence relationship
Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction

The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other types of fixation material.

The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 112 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.

The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure.

All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.

The study will be conducted in France in 3 investigational centres including 112 patients scheduled for an abdominal wall reconstruction.

Each patient will participate in one assessment period including a preoperative visit, followed by the day of surgical procedure and a hospitalization period.

Patients will return for ambulatory visits on day 30 (+/- 7 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery.

CELLIS will be implanted by open technique following standard techniques. The membrane can be used in bridged or reinforced repairs. Mesh placement can include inlay (bridging), underlay intraperitoneal, sublay (retrorectus/retromuscular) positions.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥18 years,
* Patient with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure,
* Patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
* Patient being informed of the porcine origin of the device in advance of the procedure.

Exclusion Criteria:

* Patient with known hypersensitivity to porcine materials,
* Patient who is pregnant,
* Patient having refused to participate to the study,
* Patient refusing to return for the follow-up visits.
Antitumoral Activity and Safety of AEZS-108 in Women With LHRH Receptor Positive Gynecological Tumors

The purpose of this study is to determine whether AEZS-108 shows anti-tumor activity and is tolerated in patients with gynecological tumors (ovarian / endometrial cancer) that have been shown to express receptors for the luteinizing hormone releasing hormone (LHRH)

The ovary and the endometrium are hormone dependent organs. Receptors for different sex hormones are found commonly in epithelial ovarian and endometrial cancers. LHRH and its receptors are expressed in about 80% of human ovarian and endometrial cancers. As binding sites are present on tumors in higher concentrations than on most normal tissues, these receptors represent a specific target for AEZS-108 in which doxorubicin is coupled to an LHRH analog.

Patients whose tumor specimen have shown to be positive for LHRH receptor expression will be investigated for tumor response and tolerability.

Eligibility Criteria:
Inclusion Criteria:

* LHRH receptor positive tumor status: positive receptor status determined by immunohistochemistry from primary tumor
* Histologically confirmed epithelial ovarian cancer (Stratum A)
* Advanced (FIGO III or IV) or recurrent disease
* Progression during treatment with a platinum-based regimen or within 6 months after receiving a platinum-based regimen
* Previous treatment with a taxane-containing regimen
* At least one measurable target lesion (RECIST criteria) OR CA125 level higher than twice the upper limit of normal range (GCIG criteria)
* Histologically confirmed endometrial cancer (Stratum B)
* Advanced (FIGO III or IV) or recurrent disease not amenable to potentially curative treatment with local surgery and/or radiation therapy
* No previous anthracycline-based chemotherapy
* At least one measurable target lesion according to RECIST criteria
An Analysis of the Efficacy of Different Teaching Modalities

Didactic lectures are the currently used mode of imparting training to medical students. Use of other modes of teaching like simulation is still in its infancy. Simulation, as a teaching tool may aid in longer retention of the learning contents and also provides a safe environment for the students to practice their skills after knowledge acquisition. The aim of the study is to analyze the efficacy of different teaching modalities in imparting a particular skill, namely adult cardiopulmonary resuscitation (CPR) which is a life saving skill in first year medical students. The study population includes all the first year MBBS students and the duration of the study is 1 month. A clarity as to which mode of teaching will be ideal for memory retention is the expected outcome of this study.

Introduction

Our current medical curriculum devotes a large percentage of its time to knowledge acquisition by means of didactic lectures. Psychomotor skill acquisition takes a back seat. Certain lifesaving skills like basic life support skill training have not even made an appearance in the current curriculum. Equal time distribution to cognitive and psychomotor skills should be allotted for a subject as practical as MBBS .Simulation can prove to be a valuable tool in imparting skill training. The present study aims to evaluate the efficacy of different teaching modalities in imparting lifesaving skills in first year MBBS students.

Methods

This Cross sectional study is conducted among 33 first year students who consented to participate. Institutional ethics clearance was also obtained. The students were divided into three groups, each undergoing didactic lecture, animation based videos and simulation studies. Pretest, posttest and skills test was administered to them. One way anova, Paired t test were some of the statistical test employed using SPSS version 21.

Eligibility Criteria:
Inclusion Criteria:

* All First year MBBS Students who are willing to participate

Exclusion Criteria:

* Prior training in adult CPR skills
* Physical disabilities that does not permit performing high quality CPR