cyrilzakka/clinical-trials huggingface dataset:
Accuracy of Endomyometrial Biopsy in Diagnosis of Adenomyosis

This study will compare the accuracy of diagnosing adenomyosis by obtaining hysteroscopic guided endomyometrial biopsy and comparing it to accuracy of diagnosis by transvaginal ultrasound and magnetic resonance imaging.

Preoperative diagnosis of adenomyosis is usually difficult. The use of ultrasound and MRI for preoperative diagnosis is still of low positive predictive values. The majority of cases of adenomyosis are diagnosed postoperatively after justo pathological examination of the hysterectomy specimens.

The introduction of the concept of preoperative diagnosis of adenomyosis through a hysteroscopic endomyometrial biopsies may be a very good method for preoperative diagnosis of this condition. Participants patients who are diagnosed as adenomyosis by Ultrasound and MRI and scheduled for hysterectomy will undergo an endomyometrial biopsy. The accuracy of this method, its sensitivity, specificity, positive and negative predictive values of this method will be compared with the conventional methods for preoperative diagnosis of adenomyosis after final diagnosis by final gusto pathological diagnosis of hysterectomy specimens.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with abnormal uterine bleeding due to adenomyosis diagnosed by transvaginal ultrasound and mri and scheduled for hysterectomy

Exclusion Criteria:

* hysterectomy not performed
* incomplete ultrasound and mri information
Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection

Comparing two different corticosteroids (dexamethasone and triamcinolone) for use in sacroiliac joint injections

Patients eligible for a sacroiliac joint injection will be randomized to receive one of two different steroids, dexamethasone or triamcinolone. The response immediately after injection will be assessed to confirm the diagnosis, and then they will be followed for three month to assess the degree of pain relief experienced

Eligibility Criteria:
Inclusion Criteria:

* Aged \>18, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits
* Unilateral low back/buttocks pain of at least 2 weeks.
* Patient reported 7 day average of numeric pain rating score (NPRS) low back/buttocks pain of at least 5/10 at baseline evaluation
* Clinical diagnosis of sacroiliac joint pain as diagnosed by a board certified Physiatrist including history of low back/buttocks pain and at least 2 positive physical exam findings (including positive fortin finger sign, pain with palpation of posterior superior iliac spine, positive FABER's test, positive Gaenslan's test, positive sacral distraction, positive thigh thrust, positive lateral compression, positive sacral thrust)
* Patient consents to sacroiliac joint corticosteroid injection in a shared decision-making process with the treating physician.
* 80% or more relief of index pain within first 5-15 minutes after injection

Exclusion Criteria:

* Clinical suspicion of alternative process is greater than clinical suspicion of sacroiliac joint pain
* Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
* Those involved in active litigation relevant to their pain.
* Those unable to read English and complete the assessment instruments.
* Those unable to attend follow up appointments
* The patient is incarcerated.
* History of prior sacroiliac joint fusion
* Progressive lower extremity neurologic deficit (from active radiculopathy, unhealed radiculopathy, or neuromuscular disease)
* Sacroiliac joint steroid injection within the prior 12 months
* 2 Positive lumbar medial branch blocks within the past 12 months
* Radiofrequency ablation of the lumbar spine within the past 12 months
* Lumbar facet steroid injections within the past 12 months
* Prior epidural steroid injection within the prior 3 months in any location within the spine.
* Possible pregnancy or other reason that precludes the use of fluoroscopy.
* Allergy to steroid, contrast media, or local anesthetics.
* BMI\>40.
* Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
* Active infection or treatment of infection with antibiotics within the past 7 days.
* Medical conditions causing significant functional disability (e.g., stroke, decompensated COPD, decompensated heart failure)
* Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
* Addictive behavior, severe clinical depression, or psychotic features.
Retapamulin as a Decolonizing Agent for MRSA

The purpose of this study is to investigate the efficacy of retapamulin to reduce carriage of MRSA via a randomized, double-blind, placebo-controlled clinical study testing retapamulin among patients with confirmed mupirocin-resistant nasal and/or rectal MRSA colonization. The sample size will include 27 subjects in each of the two arms of the study (retapamulin versus placebo) for a total of 54 subjects. Participants who are found to be nasal and/or rectal colonized with MRSA will be randomized to receive either retapamulin or placebo applied nasally and rectally for a total of 5 days. Nasal and rectal swabs will be collected at pre-defined time points during study duration (screening swab, swab one week after completion of topical therapy, swab 4 weeks after completion of topical therapy) to assess MRSA colonization status. The colonization rates of both groups will be assessed via Fisher's Exact Test.


Eligibility Criteria:
Inclusion Criteria:

1. Admission to the general pediatric floor and pediatric intensive care units at NYU Langone Medical Center or visit to study team members at ODA clinic (Park Ave locations) in Williamsburg Brooklyn.
2. Ages 9 months to 17 years
3. Residing in the zip codes which reflect Orthodox Jewish neighborhoods where there is a current outbreak of this strain of MRSA.
4. Nasal and/or rectal culture positive for mupirocin-resistant methicillin-resistant Staphylococcus aureus (MRSA)

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Pregnant or lactating
2. Unable to appropriately consent
3. Open sores in either of the study sites (nares or rectum)
4. Recent surgical procedure to either study site (nares or rectum)
5. Concurrent use of Rifampin or Trimethoprim/Sulfamethoxazole
6. Current active MRSA infection
7. Immunocompromised
8. Presence of endotracheal tube, tracheostomy tube or other foreign body in upper airway
A Study to Determine the Safety and Efficacy of Rilpivirine in Treatment-naive Indian Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection

The primary purpose of the study is to evaluate the efficacy of rilpivirine (RPV)-based regimen in human immunodeficiency virus type 1 (HIV-1) infected, antiretroviral (ARV) treatment-naive participants, as determined by the percentage of virologic responders defined as having HIV-1 ribonucleic acid (RNA) less than 400 copies/ milliliter (mL) at Week 24.


Eligibility Criteria:
Inclusion Criteria:

* Must have documented human immunodeficiency virus type 1 (HIV-1) infection
* Must be antiretroviral (ARV) treatment-naïve
* Have plasma HIV-1 ribonucleic acid (RNA) less than (\<) 100,000 copies/milliliter (mL) at screening visit
* Have cluster of CD4+ T-cell count (greater than) \>200/ cubic millimeter (mm\^3) at screening visit
* Women of childbearing potential must have a negative serum (beta human chorionic gonadotropin \[beta hCG\]) pregnancy test at screening; and a negative urine (or serum, if required by local regulations) pregnancy test before the first dose of study

Exclusion Criteria:

* History of any primary nucleo(t)side reverse transcriptase inhibitor (N\[t\]RTI) or non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations (if testing performed locally, and results are available), as defined by the current International AIDS (acquired immunodeficiency syndrome) Society-United States (USA) (International Antiviral Society-USA) 2017 guidelines
* Has clinical or laboratory evidence of significantly decreased hepatic function or decompensation, irrespective of liver enzyme levels (hepatic insufficiency)
* Diagnosed with acute viral hepatitis at screening or before baseline
* Infected with Mycobacterium tuberculosis which is likely to require rifampicin-based treatment during the study
* Has a Grade 3 or 4 laboratory abnormality as defined by the Division of AIDS (DAIDS) for Grading the Severity of Adult and Pediatric Adverse Events criteria with the following exceptions unless clinical assessment foresees an immediate health risk to the participant: (a) Preexisting diabetes or with asymptomatic glucose Grade 3 or 4 elevations (b) Asymptomatic triglyceride or cholesterol elevations of Grade 3 or 4
Molecular Analysis of Human Neural Stem Cells

The aim of this study is to develop and optimize methods to isolate, propagate and differentiate adult human neural stem cells from patients with degenerative neurological disorders like Parkinson's disease.

In this project the investigators propose to analyze tissue samples from different nervous system regions obtained during neurosurgical procedures in order investigate the presence of neural stem cells in different cerebral areas. The investigators will also evaluate techniques for neural stem cell cryopreservation, for possible future therapeutic uses. Patients with degenerative neurological disorders like Parkinson's disease undergoing neurosurgical procedures meeting our selection criteria will be candidate for this study.

Eligibility Criteria:
Inclusion Criteria:

1. Able to give informed consent prior to study
2. Male or Female with Diagnostic Criteria of Parkinson's disease or neurodegenerative disorder undergoing a neurosurgical procedure
3. Age 35 to 85 years old
4. Parkinson's disease not due to trauma, infection, brain tumor, cerebrovascular disease
5. Hoehn and Yahr Stage III or IV
6. Parkinson's disease observed in the absence of:

   * Oculomotor palsy
   * Cerebellar sign
   * Orthostatic hypotension (drop greater than 20mmHg in mean pressure)
   * Pyramidal sign
   * Amyotrophy
7. Good general health or stable medical condition well controlled, without contraindications to anesthesia

Exclusion Criteria:

1. Patients with severe dementia and brain atrophy on MRI
2. Patients with severe hypertension; renal, liver, cardiac or other major organ disease; coagulopathy; cancer; other significant systemic illnesses; hepatitis, HIV
3. Patients older than 85 or younger than 35
4. Patients who withhold informed consent
5. Patients with a history of alcohol or drug abuse
6. Sexually active women of childbearing potential without adequate form of birth control
7. Evidence of abnormal coagulation or anticoagulant therapy
8. Pregnancy or lactation
9. History of seizure disorders or current use of antiepileptic medication
10. Severe cognitive impairment
11. Clinically significant laboratory abnormality
Comparison of Slow and Fast Transition From Stimulants to Atomoxetine in Children and Adolescents With Attention Deficit/Hyperactivity Disorder(ADHD)

Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study. Two different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10 weeks) and fast (2 weeks). Changes in ADHD symptoms and tolerability of medication will be compared between the two different switching approaches.

Study B4Z-EW-LYFJ is a phase IV multicentre, open label, controlled study in approximately 120 patients with ADHD from 6 years to 16 years of age. After the screening period, patients will be randomized (centrally in a 1:1 ratio) either to a transition period of 10 weeks (slow switching arm) or to a transition period of 2 weeks (fast switching arm). After completion of the 10 week open phase patients will be treated for a further 4 weeks with atomoxetine.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients between 6-16 years of age
* Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) diagnostic criteria for ADHD must be met
* Normal laboratory and electrocardiogram (ECG) results
* Normal intelligence
* Must have unsatisfactory symptom response to stimulant therapy or experience of adverse events while on stimulant therapy

Exclusion Criteria:

* Less than 20 kg or more than 70 kg at study entry
* Concomitant major psychiatry disorders, drug or alcohol abuse or serious suicide risk
* Medical conditions such as seizures, severe allergies, glaucoma, cardiovascular disease, hypertension, or acute or unstable medical conditions
* Taking of anticonvulsants, antihypertensive agents, medication with sympathomimetic activity, psychotropic medications, monoamine oxidase inhibitor
* Immediate need for stimulant discontinuation due to tolerability problems
* Previous participation in an atomoxetine study, or unresponsive to atomoxetine, or intolerable side effects to atomoxetine
Low Level Laser Therapy Applied in Orthodontic Tooth Movement

Currently, orthodontic treatment takes 2-3 years.. If we accelerate tooth movement by low energy laser therapy, we could reduce treatment time. Low Level Laser Therapy(LLLT) applied in Orthodontic Tooth Movement, which stimulates formation of osteoclast-like cells expression in vitro. Osteoclast can be served as an index for tooth movement. Increasing the number of osteoclast will increase bone formation and tooth movement. We plan to find a useful clinical protocol to improve the efficiency of orthodontic tooth movement. Test low energy laser in vitro. Find an effective wavelength and irradiation time to stimulate formation of osteoclast. Develop an useful protocol that clinical orthodontist could follow and reduce orthodontic treatment time.


Eligibility Criteria:
Inclusion Criteria:

* Patients with good oral hygiene
* 18 years old
* Patients who required bilateral canine retraction into the extracted premolar

Exclusion Criteria:

* Serious medical history
* Poor oral hygiene
* Previous orthodontic treatment
* Orthognathic surgery or syndromic patients
Stereotactic Body Radiation Therapy in Treating Patients with Recurrent Primary Ovarian or Uterine Cancer

This phase I trial studies the side effects and best dose of stereotactic body radiation therapy in treating patients with ovarian or uterine cancer that has come back. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue.

This is a phase I study with a primary objective to determine maximum tolerated dose (MTD) of 3 fraction stereotactic body radiation therapy (SBRT) for abdominopelvic recurrences of ovarian cancer (OC) and uterine papillary serous carcinoma (UPSC). This is a dose escalation study that employs a 3+3 design to determine the MTD. Patients are then monitored closely to determine side effects and adverse events, as well as success rates and tumor response to the radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Female patients \> 18 years of age.
* ECOG 0 or 1.
* Diagnosis of primary ovarian cancer of any histology (patients with diagnoses of fallopian tube and primary peritoneal cancer are also eligible), or primary uterine cancer of papillary serous histology.
* Pathologic confirmation of eligible histology.
* Three or fewer total sites of active disease (at least one site of active disease to be treated on study must be confined to the abdomen or pelvis excluding liver and must be \< 5 cm in greatest dimension as determined by pre-screening cross-sectional imaging).
* Additional site(s) of active disease (such as parenchymal liver and lung metastases, or supraclavicular nodal metastases), should be considered for treatment (off study) with radiation, surgery, or another form of local therapy, at the discretion of the study PI.
* Systemic therapy is allowed but SBRT cannot begin until \> or = 7 days after the last cycle of systemic therapy, and systemic therapy cannot be initiated or re-initiated until \> or = 7 days after SBRT. There will be no limit on prior lines of systemic therapy.
* Patients with contraindications to intravenous (IV) contrast administration are still eligible for this study if the tumor can be delineated clearly without IV contrast (at the discretion of the treating radiation oncologist) but will not participate in the functional imaging studies.

Exclusion Criteria:

* Pregnant women. If patients are not status post bilateral salpingo-oopherectomy then pregnancy testing is required.
* Patients with active collagen vascular disease (CVD), specifically systemic lupus erythematosus or scleroderma. Patients with a history of CVD without evidence of active disease are eligible for enrollment at the discretion of the study PI.
* Patients with inflammatory bowel disease and/or GI ulcers and/or GI fistulas are eligible but only at the discretion of the study PI after personalized review of their medical history and proximity of SBRT targets to gastrointestinal mucosa.
* Patients with a separate non-cutaneous cancer diagnosis for which the patient has not been without evidence of disease for at least 5 years.
Neoantigen-primed DC Vaccines Therapy for Refractory Lung Cancer

Various of immunotherapies are now widely applied in the treatment of lung cancer. Neoantigens arising from the mutations of the tumor genome expressed specifically on the tumor cell instead of normal cells, suggesting that vaccines targeting neoantigens should generate a highly tumor-specific response with minimal off-target effects. Neoantigens are highly suitable for the development of cancer vaccines. The study aims to evaluate the safety and efficacy of neoantigen-loaded dendritic cell (DC) vaccines for refractory lung cancer.

Cancer genome research has exploded benefits from the application of modern high-throughput genome sequencing in the past few years. Since usually there are no common antigens expressed on the surfaces of different kinds of tumors, neoantigens which expressed specifically in the individual tumor are chosen to establish tumor-specific vaccines.

30 patients with refractory lung cancer would be enrolled and undergo tumor resection if all requirements are met. The whole-exome sequencing and the bioinformatic analysis of the resected specimens would be performed to identify the neoantigens. Then, candidate neoantigens would be synthesized to pulse the matured DC cells. Neoantigen-primed DC vaccines are provided to the corresponding patients. Each patient would be vaccinated 6 times in total, one shot per week.

Patients enrolled would undergo the schemed follow-up, one time per three months. The side effects, overall survival, and progress-free survival would be recorded. At the end of the research, the safety and efficacy of neoantigen DC vaccines for refractory lung cancer would be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years ≤ 70 years at the time of informed consent
* Signed informed consent to be provided
* pathologically confirmed lung cancer
* failed in previous standard chemotherapy and targeted therapy
* Life expectancy not less than 90 days
* Karnofsky performance status 0-1
* adequate organ functions

Exclusion Criteria:

* Actively infectious condition including hepatitis
* Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant.
* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities).
* Active systemic infections, coagulation disorders or any other active major medical illnesses.
* Patients who are receiving any other investigational agents.
Impact of Intestinal Virome on Pediatric Inflammatory Bowel Disease

Over the last few years, dysbiosis has emerged as a possible trigger of gut inflammation in inflammatory bowel disease (IBD) and a promising therapeutic target. The complex diversity of microbiota was initially highlighted by the powerful new tools in genetics, including next-generation sequencing (NGS). NGS permitted to decipher the composition of bacterial intestinal communities, but also that of the gut virome. Since then, the evidence of a dynamic instability of the enteric virome in IBD has grown considerably. IBD patients present an expansion of bacteriophages (Caudovirales) associated with decreased bacterial diversity. Moreover, gut virome richness seems to differ between Crohn's disease (CD) and ulcerative colitis (UC) patients. These insights open the gate of new diagnostic, predictive, and therapeutic approaches. However, little is known about pediatric IBD gut virome in terms of variability and evolution under the influence of different treatments (exclusive enteral nutrition, immunosuppressive therapy and biologics). The aim of this study is to evaluate the gut family viral diversity and relative abundance of eukaryotes and prokaryotes in paediatric IBD patients


Eligibility Criteria:
Inclusion Criteria:

* Age: 6-17 years
* Follow-up in pediatric gastroenterology for inflammatory bowel disease :

  * Crohn's disease
  * Hemorrhagic rectocolitis
* Introduction of anti-TNFa treatment in the Pediatric Gastroenterology Day Hospital of the "Hôpital Femme Mère Enfant" service in Lyon
* Collection of the non-opposition of at least one of the holders of the parental authority present and the child in the medical file

Exclusion Criteria:

* Refusal to participate in the study
* Antibiotherapy in the 4 weeks preceding the sampling
* Patient with ileostomy or colostomy.
* Patient who has undergone extensive bowel resection.
* History of intestinal surgery (except appendectomy)
* Patient subject to a legal protection measure
Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD.

The goal of this study is to evaluate the hypothesis that the addition of liraglutide, a long-acting glucagon-like peptide 1 (GLP-1) analogue, to a calorie-restricted diet will lead to greater weight loss than will a calorie-restricted diet alone in subjects who are older (50 to 60 years of age), overweight/obese, and prediabetic. These individuals have been selected for study because they are at greatly increased risk to develop type 2 diabetes (2DM) and cardiovascular disease (CVD), and it is hypothesized that the addition of liraglutide to a calorie-restricted diet will significantly decrease risk of these adverse outcomes.

There is considerable evidence that GLP-I compounds, including liraglutide, improve glycemic control in patients with manifest 2DM. However, there is relatively little information as to the potential utility of these compounds in nondiabetic individual at greatly increased risk of 2DM and CVD. This research proposal is aimed at providing some of this information by quantifying the effects of liraglutide, a long-acting GLP-1 analogue, on weight loss, insulin secretion, insulin action, and multiple CVD risk factors in a very high risk group-older, overweight/obese, prediabetic individuals. Furthermore, by using specific methods, not surrogate estimates, and avoiding the confounding effects of glucotoxicity, it will be possible to gain new insights into the effects of GLP-1 on insulin secretion and insulin action.


Eligibility Criteria:
Inclusion Criteria:

IFG, or IGT BMI 27.0-37.0 kg/m2

Exclusion Criteria:

DM, CAD, severe anemia, kidney or liver disease, hx of pancreatitis, gallstones, ETOH abuse, personnel or family history of medullary thyroid carcinoma or MEN-2