cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Platelet Rich Fibrin / Biphasic Calcium Phosphate Effect Versus Autogenous Bone Graft on Reconstruction of Alveolar Cleft

P- Maxillary alveolar cleft defects I- Platelet-rich fibrin (PRF) combined with biphasic calcium phosphate (BCP) C- Autogenous bone graft O- Outcome measure : bone height, bone volume, hospital stay, operation duration T- 6 months S- Randomized controlled clinical trial this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch.

this study aimed to answer a clinical question whether the use of Platelet-rich Fibrin (PRF) combined with Biphasic Calcium Phosphate (BCP), can be an alternative to autogenous bone graft in reconstruction of alveolar cleft defect in maxillary arch

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from maxillary alveolar cleft
* Patients' age 8 years and older

Exclusion Criteria:

* Syndromic cases will be excluded
* Patients suffering from platelets disorders.
Total Neoadjuvant Treatment Combined With Adaptive Radiotherapy for Rectal Cancer

Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment).

This study therefore investigates the benefit of on-couch adaptation for locally advanced rectal cancer patients undergoing this treatment regime.

This is a prospective single-arm study investigating the benefit of on-couch adaptation for locally advanced rectal cancer patients prescribed with pre-operative sequential short-course radiotherapy (RT) followed by Oxaliplatin-combined chemotherapy (mFOLFOX(6) or CAPOX). On-couch adaptation, where the radiation dose is tailored to the anatomy of the patient at each radiotherapy session. Firstly, the study will investigate if on-couch adaptation result in less gastro-intestinal adverse events, secondly it will reveal if this possible reduction lead to more patients being able to fulfill all cycles of prescribed chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with loco-regional advanced rectal adenocarcinoma with clinical indications for short-course with TNT chemotherapy i.e. having at least one of the following T4a, CRM+ (≤1 mm), N1c, N2 or extramural vascular invasion (EMVI+). Patients presenting at least one of these criteria in addition to involvement of the pelvic sidewall lymph nodes (PSW) can optionally be considered.
* ECOG status ≤ 1
* Being willing and able to give full written consent for participation

Exclusion Criteria:

* Previous rectal cancer treatment
* Previous irradiation to the treatment area e.g. prostate cancer
* Hip prosthesis
* Contraindications to MRI
* Pregnancy
* Abnormal DPYD genotype
* Known contraindication to 5-FU, Capecitabine or Oxaliplatin as judged by the investigators
National Prevalence and Impact of Noninvasive Prenatal Testing

Information on pregnant women undergoing non-invasive prenatal testing (NIPT) at one of the Obstetrix Medical Groups Outpatient Centers between January 2012 and June 2014 will be retrospectively gathered and an analysis of the impact and prevalence of NIPT. This will be compared to a control group of pregnant women in those same practices undergoing prenatal testing during the months of January 2010-July 2010.

Information regarding the frequency of non-invasive testing (NIPT), the impact of screening on the need for and frequency of invasive testing, and the indications for testing are important for the clinicians in this country to not only understand the impact that this testing has had but also to plan for allocation of personnel and resources in their prenatal testing units, as well as many other more subtle changes including describing changes to referring clinicians and patients and projecting financial impacts. Information on pregnant women undergoing NIPT at one of the Obstetrix Medical Groups Outpatient Centers between January 2012 and June 2014 will be retrospectively gathered and compared to a control group of pregnant women in those same practices undergoing invasive prenatal diagnostic testing for fetal karyotype (IDTFK) during the months of January 2010-July 2010. An analysis of the impact of NIPT will be done.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant Women
* Presented to a participating Obstetrix Outpatient Center for an invasive prenatal diagnostic testing for fetal karyotype (IDTFK) (i.e. amniocentesis or CVS).
* Invasive prenatal diagnostic testing for fetal karyotype (IDTFK) (i.e. amniocentesis or CVS) performed between January 2012 and June 2014 (A control group enrolled between January 2010 - July 2010)

Exclusion Criteria:

* Patient less than 18 years of age
* Patients not receiving a invasive prenatal diagnostic testing for fetal karyotype (IDTFK)(i.e. amniocentesis or CVS) at a participating study center
* Testing NOT done within the window for inclusion (Jan 2012 - June 2014) or Control Group window (January 2010 - July 2010)
Umbilical Cord Derived Mesenchymal Stem Cells Transplantation for Active and Refractory Systemic Lupus Erythematosus

This study will explore safety and efficacy of allogeneic umbilical cord (UC) derived mesenchymal stem cells transplantation (MSCT) to treat patients with active and refractory systemic lupus erythematosus (SLE) who have been resistant to multiple standard treatments. The underlying hypothesis is that the active SLE condition is caused by an abnormal immune homeostasis that can be restored by MSCT.

Inclusion Criteria:

1. All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 70 years old, SLEDAI≥8;
2. Lupus nephritis with 24h urine protein≥1g;
3. Refractory disease as determined by failure of the following regimens:

   Trial of corticosteroids (oral prednisone more than 20 mg/day); Trial of cyclophosphamide 0.4 \~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as mycophenolate mofetil 2 g / day, for three months;
4. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
5. Willing to use contraception throughout the study and for 12 months following treatment

Eligibility Criteria:
Inclusion Criteria:

* All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man or woman aged from 15 to 60 years old, SLEDAI≥8;
* Lupus nephritis with 24h urine protein≥1g;
* Refractory disease as determined by failure of the following regimens:

Trial of corticosteroids (oral prednisone more than 20 mg/day); Trial of cyclophosphamide 0.4 \~ 0.6 / m2 every two weeks for six months, or other immunosuppressive drugs, such as mycophenolate mofetil 2 g / day, for three months;

* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital;
* Willing to use contraception throughout the study and for 12 months following treatment

Exclusion Criteria:

* Abnormal liver function (ALT higher than 3 times the normal value);
* End-stage renal failure;
* Severe heart and pulmonary failure, or other important organs damage;
* Uncontrolled infections
* Pregnant or breast feeding women, male or female who intended to recent pregnancy
The Genetics of Dilated Cardiomyopathy: A Quebec-Based Study

Dilated cardiomyopathy (DCM) affects about 200,000 Canadians. Eighty percent of these cases are of unclear cause, often occuring in families. We believe that mutations in specific already-identified genes contribute to DCM in Quebec and that certain mutations may account for a significant proportion of cases due to the well-documented "founder effect". Two hundred patients with DCM followed in our Heart Function Clinic will be approached for one blood sample at their routine clinic visit to test this hypothesis. The samples will be tested in the Laboratory of Cardiovascular Genetics at the Royal Victoria Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Followed at MUHC Heart Function Centre
* Documented EF of less than or equal to 35% and an enlarged heart with a left ventricular end-diastolic size of greater than 6 cm.
* Patient's written consent

Exclusion Criteria:

* Patients with a known underlying condition that results in a weakened and enlarged heart
* Patients unable to read and understand the consent form
* Patients who do not wish to participate
A COVID-19 Symptom, Exposure and Immune Response Registry

This is a 6-month, 100% remote study that will collect a broad range of data that may provide insight into the COVID-19 global pandemic. Data collected will include participant medical histories, history of prior SARS-CoV-2 infection and exposure to known cases. On an ongoing basis data will be collected on new contacts with known cases, the presence of COVID-19 symptoms, including severity and outcome, and information on the immune system response to SARS-CoV-2 infection.

This is a 6-month, 100% remote study that will collect a broad range of data that may provide insight into the COVID-19 global pandemic. All data will be collected by participant entry into a mobile app designed for this study.

Upon entering the study, participants will be asked a series of questions about their prior exposure to the SARS-CoV-2 virus including reporting prior test results, and identification and description of contact with known or cases or other high risk encounters. Participants will also provide a detailed medical history.

On on ongoing basis, participants will be asked to report any symptoms associated with COVID-19 that they develop, and any new contacts they experience with known cases. Some participants will be sent an at-home SARS-CoV-2 antibody test and asked to report the results. In addition, participants will be asked to report the result of any other test they receive for COVID-19 outside of the study.

Eligibility Criteria:
Inclusion Criteria:

* Open to any adult individuals (18 years of age or older) permanently residing in the United States
* Have regular access to smartphone and internet sufficient to support registry demands
* Willing and able to follow the procedures of the study
* Willing and able to provide informed consent

Exclusion Criteria:

* Participants unable to understand the study protocol or provide informed consent
* Participants unable or unwilling to perform all requested study tasks
Treatment of Retentive Teeth

The relevance of the research topic is beyond doubt, since this work is devoted to improving the effectiveness of treatment of patients with permanent teeth that have not erupted in a timely manner. Currently, this pathology occurs in 4-18% of patients seeking specialized help in a dental clinic.

The anomaly of teething, first of all, affects the anatomical, functional and aesthetic characteristics, there is an influence on the psycho-emotional state of the patient. Despite a significant number of scientific studies by domestic and foreign authors, some features of the treatment of patients with dental retention are insufficiently covered and systematized. At the moment, there is no optimal approach to the diagnosis and treatment of dental retention, as a result of which there is a question of improving the effectiveness and quality of orthodontic treatment of patients with a diagnosis of "tooth retention".

The purpose of the study Improving the effectiveness of treatment of patients with dental retention. Research objectives

1. To determine the frequency of occurrence of dental retention according to the patients' requests for orthodontic care;
2. Based on the cephalometric study to identify the features of the structure of the face and bone structures in patients with dental retention;
3. Develop and implement an orthodontic device to obtain additional space in the dentition in patients with retention;
4. To develop and introduce into clinical practice a method for creating surgical access to retentive teeth using digital technologies.
5. To conduct a comparative analysis of the effectiveness of our proposed improved stages of treatment of patients with dental retention with well-known methods based on gnatic and profilometric indicators.

Materials and methods of research At the first stage of our study, it is planned to examine patients aged 15-35 years who have applied for specialized

Eligibility Criteria:
Inclusion Criteria:

* Methodology

Exclusion Criteria:

* patients without retentive teeth
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting

The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing primary liver transplantation.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent or for those individuals where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative (LAR) willing and able to provide consent on behalf of the individual.
* HCV RNA infection with quantifiable virus at screening
* Must have chronic genotype 1 or 4 HCV infection for ≥ 6 months by medical history or liver biopsy
* Currently on the liver transplantation wait list
* Screening electrocardiogram (ECG) without clinically significant abnormalities.
* A negative serum pregnancy test result is required for females

Key Exclusion Criteria:

* Any previous solid organ transplant
* Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with participant's treatment, assessment, or compliance
* HIV infection or a positive hepatitis B virus surface antigen result
* History of malignancy (with exception of hepatocellular carcinoma within Milan criteria, certain resolved skin cancers or other early cancer for which surgical resection is considered to be completely curative)
* Treatment with any approved or experimental medication with known anti-HCV activity within 1 month prior to screening date
* Prior exposure to an HCV non-structural protein (NS)5A inhibitor
* Patients on hemodialysis prior to or at the time of transplantation will be excluded
* Creatinine clearance (CLcr) \< 40 mL/min at screening or \< 40 mL/min on day of transplant
* Participation in a clinical study with an investigational drug or biologic within 28 days prior to screening visit
* Receipt or planned receipt of an organ from an HCV positive donor

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Osseodensification in Enhancing Implant Stability and Ridge Expansion in Esthetic Region

Dental implants supported restorations have been widely accepted as one of the treatment modalities to replace missing teeth and to restore human masticatory function. Successful osseointegration from the clinical standpoint is a measured by implant stability, which occurs after implant integration. Osseodensification is a bio-mechanical site preparation technique. It utilizes a multi-fluted densifying bur technology that creates and expands a pilot hole without excavating significant amounts of bone tissue through a unique, highly controllable, fast, and efficient procedure with minimal heat elevation.

Aim of the study: Is to evaluate and compare the efficacy of using osseodensification compared to conventional bone expansion in implant stability and ridge expansion.


Eligibility Criteria:
Inclusion Criteria:

* Missing maxillary anterior tooth, having moderate horizontal ridge defect in which the alveolar ridge width is( 3-4) mm, and its height is not less than 10 mm.
* Presence of adequate keratinized mucosa.
* Patients with good oral hygiene.
* Patients are free from any systemic diseases that might affect healing.
* Presence of adequate inter-occlusal and mesiodistal space that permits placement of fixed prosthesis.

Exclusion Criteria:

* Heavy smokers and bad oral hygiene patients.
* Medically compromised patients that affecting placement of implant.
* Alcohol or drug abuse.
* Pregnant women.
* Patients suffering from osteoporosis.
* Current chemotherapy or radiotherapy.
Treatment of Chronic Antibody-mediated Rejection in Kidney Transplant With Acthar

This is an open label safety and feasibility trial using Acthar® in addition to the investigators center-specific standard therapy, which could include increase in maintenance immunosuppression, high dose IVIG (intravenous immunoglobulin) (2 g/Kg), and/or Rituximab, in patients with chronic antibody-mediated rejection (CAMR).

Subjects will receive Acthar® 40 units twice a week subcutaneously for 2 weeks. If the drug is well tolerated the dose will be increased to 80 units twice a week for another 22 weeks. The patients will be maintained on their center-specific standard maintenance regimen, typically consisting of Tacrolimus, mycephenolate mofetil/Sodium, and prednisone.

After screening for the inclusion/exclusion criteria, the patients will be consented and enrolled in the study. The initial visit and subsequent study-related visits at 4, 8, 12, 24, 36 and 52 weeks will include routine evaluation and physical examination and laboratory studies including CBC (complete blood count), electrolyte panel, eGFR, albumin, liver enzymes, and Calcineurin inhibitor (CNI)/sirolimus drug level, according to the center's standard of care. Donor-specific antibody (DSA) will be tested at week 24, and 52 and patients will undergo a biopsy at week 52, as a part of the investigators standard of care. The biopsies will be evaluated by light and electron microscopy using standard histological Banff criteria, and staining for CD68.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Morphologic diagnosis of CAMR, by light \&/or electron microscopy any time after transplantation
* Current or previously documented donor-specific antibody (DSA) and/or focal or diffuse peritubular capillary C4d staining by immunohistochemistry
* eGFR\>25 ml/min

Exclusion Criteria:

* Diagnosis of malignancy within a year prior to enrollment (except cured cutaneous basal cell or squamous cell carcinoma).
* Lack of evidence of antibody involvement
* Pregnancy, lactation, or refusal to use birth control in women of child bearing potential
* Active infection, or history of HIV
* History of liver or thoracic transplant
Neutropenic Sepsis in Patients With Non-Small Cell Lung Cancer Treated With Single-Agent Docetaxel and Associated Resource Use in the UK

This is a multi-center retrospective observational research study collecting data for participants initiated on docetaxel for the treatment of relapsed non-small cell lung cancer (NSCLC) up to 6 years before start of data collection and who have completed/stopped docetaxel treatment at least 30 days prior to data collection. The primary goal of this study is to describe the percentage of participants with at least one neutropenic sepsis (NS) episode following initiation of treatment with single-agent docetaxel. Data will be collected until end of docetaxel treatment plus an additional 30 days to allow for presentation with toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with locally advanced or metastatic (stage Ill or IV) non-small cell lung cancer (NSCLC)
* Relapsed disease following, or unable to tolerate, at least one line of prior chemotherapy
* Initiated on single-agent docetaxel up to a maximum of 6 years prior to date of collection
* Aged 18 years at date of first docetaxel dose
* Completed or stopped treatment with docetaxel at least 30 days prior to date of data collection

Exclusion Criteria:

* Receiving docetaxel in an interventional clinical trial
* For whom no details of absolute neutrophil count are recorded
A Mind-Body Medicine Curriculum for Peer Counselors

This study will evaluate a Mind-Body Medicine curriculum for high school peer counselors in order to answer the following research questions:

1. Will peer counselor participation in the Mind-Body Medicine curriculum increase their sense of self-regulation, responsibility, social competence, and empathy; decrease anxiety; and increase hope?
2. What are the experiences of peer support counselors participating in the Mind-Body Medicine curriculum?

The study will be done at the Marjory Stoneman Douglas High School. The research will use a mixed-methods design by collecting both quantitative and qualitative data. The quantitative data will be in the form of standardized research instruments and the qualitative data will be gathered through focus group interviews with the peer-counselors.

Eligibility Criteria:
Inclusion Criteria:

• All high school students who are participating in the Peer Counseling Program at Marjory Stoneman Douglas High School

Exclusion Criteria:

• None (as long as the students meet the inclusion criteria)
Uterine Artery Embolization and Pelvic Floor Symptoms

The objective of this study is to determine whether women who are already receiving treatment for their fibroids (ie. UAE) demonstrate improvement in urinary symptoms and sexual dysfunction as well.


Eligibility Criteria:
Inclusion Criteria:

* female
* age 18-80 years
* symptomatic uterine fibroids
* scheduled for UAE
* Negative urine dipstick (negative result = trace or less for leukocytes \& nitrites) or negative UA or negative culture (Urine dipstick is performed as standard of care)
* Available for 12-months of follow-up and able to complete study assessments, per clinician judgment
* Signed consent form

Exclusion Criteria:

* Age \<18 or \>80 years
* women who are unable to read and write English,
* pregnancy or planned pregnancy in the next 12 months
* \< 6 months postpartum
* current use of anticholinergic medication, cholinergic agonists, tricyclic antidepressants, or duloxetine - must have been off such drugs for at least 4 weeks
* women with surgery for urinary incontinence or pelvic organ prolapse in the past 6 months
* history of bladder or pelvic cancer or pelvic radiation therapy
* prior augmentation cystoplasty
* urethral diverticulum, current or repaired.
Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso

The purpose of this study is to develop, implement and evaluate a comprehensive breast and cervical cancer screening program designed to increase uptake of breast and cervical cancer screening among rarely and never-screened low-income women in El Paso County and to increase repeat screening among those currently overdue.


Eligibility Criteria:
Inclusion Criteria:

* overdue for a repeat mammogram
* overdue for repeat cervical screening

Exclusion Criteria:

-