cyrilzakka/clinical-trials huggingface dataset:
Simplified Diagnostic Algorithm for Evaluation of Neonates With Prenatally Detected Hydronephrosis

Patients with congenital hydronephrosis will be identified by inpatient consultations performed by Dr. Assadi for congenital hydronephrosis and by outpatient problem lists with congenital hydronephrosis of Dr. Assadi's existing patients. Given standard evaluation will be evaluated to determine if based on initial ultrasound classification an algorithm can be developed to target evaluation studies for the initial evaluation. With a goal of targeting the few children that have need of additional intervention and minimizing the studies performed on children who will spontaneously resolve.

Patients with congenital hydronephrosis will be identified by inpatient consultations performed by Dr. Assadi for congenital hydronephrosis and by outpatient problem lists with congenital hydronephrosis of Dr. Assadi's existing patients. Once identified, the patient's grade of hydronephrosis will be recorded from initial ultrasound based on Society of Fetal Urology (SFU) classification. If no initial SFU classification was assigned to the hydronephrosis a pediatric radiologist will review the initial ultrasound images and classify the grade of hydronephrosis based upon SFU criteria. The patients ensuing evaluation of their hydronephrosis that took place will then be recorded and de-identified. Data to be collected will include: Ultrasound evaluations of the abdomen, retroperitoneum, or renal system, Voiding Cysto-Urethrogram (VCUGs), nuclear studies: diuretic enhanced technetium-99m dietylene triamine penta-acetic acid renogram (DTPA) or technetium-99m Mercapto-acetyl-triglycine renogram (MAG3), referral to pediatric urology for pyeloplasty, serum electrolytes, Blood Urea Nitrogen (BUN) and creatinine, urinalysis, urinary tract infections, and placement on long-term antibiotic prophylaxis.

The follow up evaluation that took place for each patient will then be compared to our proposed algorithm for congenital hydronephrosis evaluation and treatment. This algorithm will be designed based on clinical experience of expert opinion and literature review of each step in the evaluation and treatment. Primary outcomes will be progressive renal function decline and progression to referral to a pediatric urologist for pyeloplasty. Secondary outcomes will be incidence of urinary tract infections and placement on long term antibiotic prophylaxis for urinary tract infection prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for the study were confirmation of the diagnosis of prenatal hydronephrosis by postnatal renal ultrasound

Exclusion Criteria:

* prior history of UTI
* diagnosis of cystic renal dysplasia with poorly functioning kidney
* previous operation on the urinary tract system
* and other deformities of the external genital organs or anomalies in cardiopulmonary and central nervous system
Immediate Skeletal and Dento-alveolar Effects of Two and Four Mini-screw Supported Hyrax for Maxillary Expansion in Non-growing Patients

transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects, therefore ,recently A minis crews assisted rapid expansion is recently introduced to overcome hence complications

transverse malocclusion is very common in adult ,using conventional hyrax expander has many limitations and side effects such as buccal tipping, marginal bone loss, dento aloveolar expansion.

in such cases , surgically assisted rapid palatal expansion used to be the option of choice ,due to the invasiveness of the procedure and co-morbidity associated with it ,minis crews assisted rapid expansion is recently introduced to overcome the complications of both convectional and surgically assisted rapid palatal expansion

Eligibility Criteria:
Inclusion Criteria:

* adults male or female aged from 18-30 years with skeletal Maxillary constriction
* unilateral or bilateral Dental posterior cross-bite
* mid-palatal suture maturation (Grade C, D) according to F Angileri classification
* good oral hygiene

Exclusion Criteria:

* no functional crossbite due to premature contacts
* no previous orthodontic treatment
* no buccal crossbite
* no craniofacial anomalies or syndromes.
Bioequivalence Study On Pediatric Appropriate Formulation

To determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg commercial atorvastatin calcium tablet formulation.

Determination of Bioequivalence

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects
* Mass Index (BMI) of approximately 18 to 30 kg/m2

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* A positive urine drug screening
Clotrimazole Enemas for Pouchitis in Children and Adults

Colectomy with creation of an ileal pouch (IPAA) is now the treatment of choice for patients with ulcerative colitis that is resistant to existing medical therapies. The development of inflammation in these ileal reservoirs, a clinical entity referred to as pouchitis, is the most common long-term complication of this procedure and can affect 50-60% of adults and children. We have previously demonstrated that clotrimazole (delivered as a rectal suppository) is generally safe, effective, and displays poor systemic absorption when used in pediatric and adults with active pouchitis. We saw clinical benefit in patients with pouch disease that had previously failed to respond to standard antibiotic, steroid, or immunosuppressive therapies. The clinical trial outlined here will define the effectiveness and safety of topical clotrimazole therapy (delivered as a rectal enema) in pediatric (aged greater than two years) and adult patients with pouchitis.

Subjects in this study will be randomly assigned to receive either placebo (no active drug, 4 subjects) or one of two clotrimazole therapy groups: 2500 mg/day (8 subjects) or 4000mg/day (8 subjects). No washout period is required, and subjects will be allowed to continue their existing anti-inflammatory medications during their participation in the study. Clotrimazole will be delivered nightly in the form of an enema. Subjects will undergo flexible sigmoidoscopy (pouchoscopy) prior to and again after completing one month of study therapy, and pouch disease activity will be graded at after each procedure using the Pouchitis Disease Activity Index (PDAI). Clinical improvement will be defined as a drop in PDAI score. If the drop in PDAI scores between placebo and either active clotrimazole treatment group is not significant, and no subject experiences what are determined to be study-related adverse effects, a second cohort of subjects will be recruited and studied after receiving one month of either placebo (4 subjects), 6000 mg/day clotrimazole (8 subjects), or 7500mg/day clotrimazole (8 subjects).

Subjects will be assessed for adverse effects at the midpoint of the study. Clotrimazole blood levels will be measured during the first and last day of study participation. In addition, adults will complete a health related quality of life assessment at baseline and after completing study drug therapy.

All subjects will be eligible for one month of open-label study drug therapy after completing one month of study drug therapy.


Eligibility Criteria:
* Age greater than 2 years
* Availability of Parent or Legal Guardian (for those less than 2 years of age).
* History of ulcerative colitis treated with colectomy and ileal pouch
* Diagnosis of acute or chronic pouchitis
Phase I Trial of Envafolimab for Healthy Male Subjects

The purpose of this study is to evaluate the pharmacokinetic similarity, safety, and immunogenicity of Envafolimab in healthy male subjects before and after the manufacturing process change.


Eligibility Criteria:
Inclusion Criteria:

1. Be able to fully read, understand, and sign the informed consent form;
2. Male subjects aged 18-45 years
3. Clinical examinations in the screening period are normal or abnormal without clinical significance;
4. A body mass index (BMI) in the range of 19 to 26 kg/m22, and a body weight between 50 and 85 kg;
5. Use effective contraceptive methods from the beginning of the informed consent to 5 months after the use of the drug, and have no plans to give birth or donate sperm.

Exclusion Criteria:

1. Systolic blood pressure ≥140 mmHg/ diastolic blood pressure ≥90 mmHg or systolic blood pressure \< 90 mmHg/ diastolic blood pressure \< 60 mmHg, pulse \> 100 beats /min or \< 50 beats /min at screening or baseline examination;
2. QT interval (QTcF) ≥450;
3. Estimated glomerular filtration rate eGFR \< 90 ml/min/1.73m2;
4. Thyroid function beyond the normal range;
5. ALT \> ULN Or AST \> ULN;
6. Prior treatment with a PD-1/L1 inhibitor;
7. Have taken any prescription drug, over-the-counter drug, any vitamin product or herbal or health product within 14 days prior to study drug administration;
8. Had a history of upper respiratory tract infection or other acute infection within 14 days prior to study drug administration;
9. Positive hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody or syphilis.
Heparin Versus Saline in Peripheral Venous Catheter

A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter. Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.

The need of use of peripheral venous catheters and the importance of a proper management to avoid catheter colonization or phlebitis requires two possible preventive approaches: lock therapy with heparin or saline.

Heparin demonstrated its efficacy in central venous catheters, but there are still controversies of whether it is useful in peripheral venous catheters.

Objectives To compare the efficacy of heparin in peripheral venous catheters lock versus saline for the prevention of colonization and phlebitis in patients admitted to an Internal Medicine Department.

Methods: A clinical, prospective. controlled and randomized study with patients with a peripheral venous catheter.

Patients will be randomized to either receive heparin or saline. The investigators will monitored the clinical out come to further evaluate catheter colonization rate, phlebitis rate, days of hospital stay, antimicrobial costs, and adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* patients with inserted PV Catheter within 24h from admission in internal medicine

Exclusion Criteria:

* hypersensibility to heparin
* active hemorrhage
* coagulation alterations
ClinRO Sedation Validation

This study will conduct qualitative interviews to provide evidence for the content validity and comprehension of existing physician-reported measures of sedation levels of children receiving anesthesia to facilitate a diagnostic or surgical procedure. Information gained from this study will inform the use of the measure in studies that are part of the PTN.

The primary objective of this study is to assess the content validity and physician understanding of the Pediatric Sedation State Scale (PSSS) and the University of Michigan Sedation Scale (UMSS) via cognitive interviewing methods. Qualitative Interviewers will conduct 1 hour, phone-based cognitive interviews with clinicians to assess physicians' comprehension of items and response options on clinician reported pediatric sedation scales and clinician evaluation of the relevance of the scale to capture sedation levels.

Eligibility Criteria:
Inclusion Criteria:

1. Is a practicing clinician in a clinical care environment
2. Cares for pediatric patients \>50% of their time
3. Treats or works with pediatric patients who are sedated/anesthetized for diagnostic and/or therapeutic procedures
4. Holds one of the following titles/positions

   1. Anesthesiologist
   2. Pediatric critical care physician
   3. Clinical pharmacist (PharmD)
   4. Nurse anesthetist
   5. Nurse practitioner
   6. Physician assistant
   7. Nurse (with a BSN/RN or higher)
5. Is over the age of 18 years
6. Can speak English
7. Is capable of giving informed verbal consent

Exclusion Criteria:

1. Lack of access to a telephone for interview
Diagnosis Of Neurological Fetal Anomalies

This is a descriptive cross-sectional study 300 patients coming for antenatal care at sohag governorate undergo mid anatomical scan.

Samples 300 pregnant women have mid anatomical scan at 20-22 weeks as routine antenatal care and Examination of the fetal CNS will be performed with a high resolution two dimensional ultrasound machine (Voluson E8) equipped with a RAB 4 to 8MHz multifrequency transabdominal Probe. Four standard recommended views-transventricular, falx, cavum, and posterior fossa or transcerebellar views-provide an overview of fetal intracranial anatomy during the second trimester anatomy scan.

Follow-up information will be obtained in all cases, and all infants will be considered healthy by pediatric examination. In selected cases, postnatal single-shot fast spin-echo magnetic resonance (MR) imaging will be performed as integrated, complementary investigation.to confirm diagnosis.

1. Type of the study: This is a descriptive cross-sectional study
2. Study Setting: 300 patients coming for antenatal care at sohag governorate undergo routine second trimester scan.
3. patients and methods:

Inclusion criteria:

1. All pregnant females of 18 to 45 years old.
2. gestational age of 20- 22 gestational week .

Exclusion criteria:

1-age less than18years and more than 45 years. gestational age less or more than20- 22 weeks. Samples Methods 300 pregnant women low risk pregnancy will be scanned at 20-22 weeks as routine antenatal care and Examination of the fetal CNS will be performed with a high resolution two dimintional ultrasound machine (Voluson E8) equipped with a RAB 4 to 8MHz multifrequency transabdominal Probe. Four standard recommended views-transventricular, falx, cavum, and posterior fossa or transcerebellar views-provide an overview of fetal intracranial anatomy during the second trimester anatomy scan.

Follow-up information will be obtained in all cases, and all infants will be considered healthy by pediatric examination. In selected cases, postnatal single-shot fast spin-echo magnetic resonance (MR) imaging will be performed as integrated, complementary investigation.to confirm diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant females of 18 to 45 years old.
* gestatioal age of 20- 22 gestational week .

Exclusion Criteria:

* age less than18years and more than 45 years.
* gestational age less or more than20- 22 weeks.
Double Pick up in Poor Prognosis Women

The purpose of this randomized pilot study is to compare the efficacy of double oocyte retrieval vs. conventional antagonist ovarian stimulation protocol in poor prognosis patients undergoing in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI).


Eligibility Criteria:
Inclusion Criteria:

* Age 25-40 years
* Body mass index (BMI) ≤ 35 and ≥ 19
* Antimüllerian hormone (AMH) level of ≤1.5 ng/mL or antral follicular count (AFC) of ≤6 follicles or ≤5 oocytes retrieved in a previous cycle following standard conventional ovarian stimulation.

Exclusion Criteria:

* Testicular sperm extraction
* History of \> 3 three consecutive previous unsuccessful IVF cycles
* BMI \>35 or \<19
* Use of oral contraceptives \<3 months before start of the treatment
* polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
* Ovarian stimulation for pre-implantation genetic testing (PGT-A/M)
* Medical/social freezing
* In vitro maturation (IVM)
* History of untreated autoimmune, endocrine or metabolic disorders,
* Ovarian cystectomy or oophorectomy
Sensory Feedback for Touch and Proprioception With Prosthetic Limbs

Upper limb amputation is a devastating injury that leaves many thousands of typically young and active individuals in the US to rely on artificial arms and hands to help restore their lost function. The investigators research is focused on helping these individuals to feel where their prosthetic limbs are moving without having to look at them by developing devices and approaches to provide sensory feedback of limb movement through the nerves that once served the missing limb.

In the investigators research the investigators seek to understand the organization and (function/operation) of sensory neural systems in order to develop methods for restoring function to injured populations. One of the primary focus areas of the investigators research is working to integrate physiologically relevant sensory feedback with prosthetic limbs. To this end the investigators employ a variety of approaches that interweave disciplines such as electrophysiology, psychophysics, biomedical engineering and cognition. The investigators research team is composed of an interconnected and communicative network of clinicians, engineers, and scientists. This helps us to provide pathways from basic science discoveries that can be used to address clinical needs with transition directly to patient care.

Eligibility Criteria:
Inclusion Criteria:

Amputee criteria:

* Must be over 18 years of age
* Must be upper extremity amputee who has undergone targeted sensory reinnervation.

Able Bodied participants:

* Must be over 18 years of age
Patient Reported Outcome Post Radiation Therapy or Chemoradiotherapy Patient Care in Patients With Oropharyngeal Cancer

This study examines patient reported outcomes post radiation therapy or chemoradiotherapy patient care in patients with oropharyngeal cancer. This study may help researchers learn about the symptoms that patients with oropharyngeal cancer have after completing radiation therapy.

PRIMARY OBJECTIVE:

I. To provide evidence of clinically relevant symptoms for integrating into a user-friendly, automated pathway for real-time tracking and management of symptoms during post radiation therapy (RT)/chemoradiation (CRT) for oropharyngeal cancer (OPC).

OUTLINE:

Patients complete questionnaire over 10-20 minutes at baseline, 2 times every week during weeks 1-8 of radiation therapy, and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were seen for new patient evaluation at clinics and HNC centers at MD Anderson Cancer Center
* Adult patients with OPC (\> 18 years old) who have been enrolled under PA14-0947
Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?

The long-term goal of this study is to validate a simple and inexpensive intervention to reduce the incidence and impact of Postpartum Depression (PPD). The central hypothesis is that enhancing social support of new mothers specifically via an organized peer get-together will decrease rates of postpartum depression. The rationale for the proposed research is that even though PPD is common and risk factors for developing PPD are known, simple and inexpensive interventions to prevent PPD need to be studied. Postpartum mothers will be recruited for the study and randomized into control versus intervention group. The intervention group will be placed in a peer discussion group. Incidence of PPD will be tracked.

According to a 2014 Cochrane Review, postpartum depression (PPD) is present in 13% of new mothers by twelve weeks postpartum. Infant feeding, sleep routines, growth, and socioemotional and cognitive development can be adversely affected by maternal PPD. These negative effects can last into childhood. Previous studies have shown that strong social support is protective against PPD. The 2014 Cochrane Review on this topic comments that simple, inexpensive interventions to decrease rates of PPD are needed and that interventions led by lay-people and done in groups may be helpful to decrease rates of PPD. More recent studies focus on interventions for mothers already showing symptoms of postpartum depression, not on preventing these symptoms from developing.

The proposed work is important, because it capitalizes on recommendations for future research from the 2014 Cochrane Review on Psychosocial and Psychological Interventions for Preventing Postpartum Depression. The proposed work is also innovative, because it involves a preventive intervention from lay-people in a group setting, with new moms benefiting from each other. At the completion of this project, it is our expectation that mothers in the intervention group will have sustained decreased rates of PPD.

Eligibility Criteria:
Inclusion Criteria:

1. Women who deliver at the Hershey Medical Center
2. Postpartum women within first week after delivery
3. Women who are 18 years of age or older

Exclusion Criteria:

1. Postpartum women who delivered newborn before 35 0/7 gestational age.
2. Postpartum women whose newborn required any length of stay in the newborn intensive care unit.
3. Postpartum women who do not speak English.
4. Postpartum women who are less than 18 years old.
5. Postpartum women who are unable to provide consent.
6. Postpartum women who were on antidepressant or antianxiety medication or undergoing therapy for depression or anxiety during pregnancy or during postpartum hospitalization.
X-Change HF - Exchange of the Existing Pacemaker/ICD in Bradycardia Patients Suffering From Heart Failure

The goal of X-Change HF is to estimate the effect of biventricular stimulation in patients who need antibradycardia ventricular stimulation (more than 80%); are eligible for the exchange of an old pacemaker or implantable cardioverter defibrillator (ICD); and have ventricular dysfunction (left ventricular ejection fraction \[LVEF\] \< 35%). All patients eligible for participation in the study will be upgraded with a cardiac resynchronization therapy (CRT)-device and receive either right ventricular or biventricular stimulation in a crossover protocol. The endpoint is functional performance measured by spiroergometry.


Eligibility Criteria:
Inclusion Criteria:

* Implanted dual-chamber pacemaker or ICD system with replacement indication

  * Because of battery end of life
  * Because of upgrade from pacemaker to ICD system

    * predominant sinus rhythm (paroxysmal atrial fibrillation \[AF\] \< 2 hours/day)
    * predominant ventricular stimulation (\>= 80%)
    * NYHA Class II-III
    * LVEF \<= 35%

Exclusion Criteria:

* NYHA Class IV
* Life expectancy of less than one year because of accompanying diseases
* Myocardial infarction less than 3 months old
* Cardiac surgery less than 3 months

  * Bypass
  * Valve surgery
  * Percutaneous transluminal coronary angioplasty (PTCA)
* Thoracotomy, for implant of an epicardial LV electrode
* Medical circumstances that make participation and compliance impossible
* Patients who are not willing or able to give written consent for their study participation
* Participation in another study
* Patients less than 18 years old
* Pregnancy
Perfusion Assessment Using BOLD MRI and PBV in Endovascular Treatment of Peripheral Arterial Occlusive Disease

Current assessment of lower limb ischemia cannot reflect the location and degree of ischemia. Tissue perfusion assessment was used in the diagnosis and treatment of lower limb ischemia in this project, and the quantitative evaluation of ischemia degree was realized by using its advantages of quantitative analysis and perfusion imaging.


Eligibility Criteria:
Inclusion Criteria:

* Subject has been diagnosed as PAOD by symptom and imaging;
* Subject intends to take endovascular treatment in PUMCH;
* Subjects without heavy stenosis in infrapopliteal artery (stenosis\<30%), or with short length lesion(length≤5cm, stenosis≥30%);
* Age \> 35 and \< 80;
* Subject has been informed the study and has signed informed consent;

Exclusion Criteria:

* Subject with MRI contraindications or allergic to iodinated contrast medium;
* Subject underwent intervention therapy or angioplasty in target vessel within the last 3 months;
* Subject after stent implantation in superficial femoral artery;
* Subject with severe heart dysfunction, renal dysfunction, or cancer;