cyrilzakka/clinical-trials huggingface dataset:
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography

The goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined antenatal, intrapartum, maternal, and neonatal factors on cardiac function.

The main question it aims to answer are:

* What are the normal reference ranges for parameters of diastolic cardiac function in neonates?
* How are these influenced by maternal, intrapartum and neonatal factors?
* Do the diastolic changes noted during the first two days of life persist into infancy?

Participants will have four echocardiographic assessments in total:

* Two during the first 48 hours of life (prior to discharge home)
* Two during infancy (as an outpatient)

Participants will have their first echo to assess diastolic function, using both conventional and novel echocardiographic measure, within the first 6 to 18 hours of life approximately (Day 1 scan) and this will be repeated at 30 to 42 hours of life (Day 2 scan). Both scans will involve a comprehensive structural assessment to confirm normal anatomy.

All participants will be invited to return for follow-up targeted echocardiography assessments to evaluate function at approximately 6 - 9 months (Scan 3) and at approximately 12 - 18 months of life (Scan 4). At each of these visits, their weight, height, any interim hospital admissions, serious illnesses or medical issues and medications will be documented using a structured checklist format.

Eligibility Criteria:
Inclusion Criteria:

* Birth at 35 weeks gestation or above
* Informed consent obtained

Exclusion Criteria:

* Any apparent congenital anomalies
* Any known chromosomal abnormalities (except Trisomy 21)
* Any known congenital structural heart disease (except patent ductus arteriosus, atrial septal defect, patent foramen ovale or ventricular septal defect)
Nasal Decolonization of Dialysis Patients Noses

Hemodialysis patients are at high-risk for infections, specifically Staphylococcus aureus infections. The investigators propose to 1) implement a novel intervention (nasal povidone-iodine at each hemodialysis session) to prevent S. aureus infections using a stepped-wedge cluster randomized trial, and 2) evaluate the feasibility and acceptability of this intervention. If successful, this intervention can be used among hemodialysis patients, and evaluated in other high-risk patient populations to prevent S. aureus infections.

The PAINTS study is a stepped-wedge cluster randomized trial that will compare standard care to an intervention that includes nasal povidone-iodine at each hemodialysis session to determine whether nasal povidone-iodine prevents infections. The nasal povidone-iodine will be donated by 3M. This formulation of nasal povidone-iodine was developed under the Tentative Final Monograph for Health-Care Antiseptic Drug Products 21 CFR Parts 333 and 369 (Docket # 75N-183H), Federal Register Volume 59, Number 116, Friday, June 17, 1994, Proposed Rules. However, the product need not be controlled like a pharmaceutical drug. The product may be stored and controlled similarly to an iodine or alcohol skin preparation product.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients receiving outpatient chronic hemodialysis at one of the 16 study dialysis centers.

Note: the unit of randomization is the dialysis center, not the individual patient

Exclusion Criteria:

Patients receiving peritoneal dialysis or home hemodialysis Pregnant women Patients with known sensitivity or allergy to iodine (documented or verbalized) Patients with active bacterial infections Children \< 18 years of age. Patients with infections at the beginning of the study will enter the study after antibiotic treatment is complete.
Oncological and Functional Result of AbdominoPerineal Extra Levator Resection for Distal Rectal Cancer

The aim of the project is to evaluate the oncological and functional outcome of the more extensive perineal dissection - i.e the extra levator resection - in abdominoperineal resections in patients with rectal cancer.

Hypothesis: Extra levator perineal resection reduces local recurrence three year postoperatively compared to traditional abdominoperineal resection and improves QoL 2-4 years postoperatively.

Low rectal cancer treated surgically by abdominoperineal resection (APR) has worse outcome than other rectal cancers operated with low anterior resection. In order to improve the outcome in the APR group a more extensive surgical procedure - the extra levator APR - has been suggested. This study aims to investigate both the oncological and the functional outcome of this method as compared to the traditional APR.

Method: All Swedish patients undergoing abdominoperineal resection for rectal cancer 2007-2009 will be analysed regarding operative technique (traditional or extra levator resection). Data on all patients regarding pre op TNM classification, pathological report and local recurrence will be collected from the Swedish Rectal Cancer registry. A validated QoL form will be sent to each patient to further investigate the functional outcome, health economy and Quality of Life 2-4 years postoperatively.

Data will be analysed regarding 3 year recurrence rate (primary endpoint) as well as functional result and QoL (secondary endpoints) in the two different groups - i.e traditional and extra levator APR.

Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer operated with APR 2007-2009

Exclusion Criteria:

* No informed consent
Impact of Childrens Preparation Before MRI on Anxiety and Need for Anesthesia: a Prospective Randomized Clinical Trial

MRI has been recognized for many years as the safest and the most precise imaging method, particularly for children. However, the accuracy of MRI demands from the patient to avoid any movement while the examination is in process. This task is accomplished with difficulty by children and requires the assistance of an anesthetizing staff. In this research, our main goal is to investigate an introductory instruction as an assistive tool in performing MRI without the need in anesthesia.

This is a prospective randomized controlled trial in which the level of the child's exposure to instruction is controlled according to the group he is attributed to. The children are divided randomly, each Sunday (the day there is an available anesthesia staff) we change the extent of the instruction. We use two types of instructions: 1) Full interactive instruction- which will include an instructional booklet, a movie and a simulator's practice. 2) Partial instruction which will include the booklet only.

Therefore, if it is a full instruction Sunday, all the children in that day receive full instruction and vice versa, if it will is a partial instruction Sunday, all the children in that day receive partial instruction.

All participants provide written informed consent after the study aims and procedures are fully explained.

Eligibility Criteria:
Inclusion Criteria:

* All children in the age between 5 to 16 years who come ambulatory or were hospitalized to perform an MRI test, speaks Hebrew or Arabic, are capable of understanding to their age, and their parents agreed to take part in the research

Exclusion Criteria:

* Severe cerebral palsy
* Severe ADHD
* Children that lack of communication skills
Enhancing Safe Sleep Practices of Urban Low-Income Mothers

The specific aims of the study are to: 1) evaluate the impact of the safe sleep intervention on parents' knowledge, beliefs, intentions, skills and practices related to creating and maintaining a safe sleep environment for their infants during the first four months of life; 2) describe the characteristics of physician anticipatory guidance about safe sleep and identify physician, patient and parent characteristics associated with coverage of the topic at the well-child visits; and 3) evaluate the dissemination of the B'more for Healthy Babies (BHB)'s safe sleep campaign messages and services among our study participants.

This intervention trial uses a randomized controlled design and will be conducted in the Harriet Lane Clinic. The study conditions are: Standard Care Group (SG), Attention-Matched Control Group that receives a scald burn prevention intervention (CG), and Intervention Group that receives a safe sleep intervention (IG). Parents or legal guardians will be enrolled during the newborn visit (when the baby is approximately 4-7 days old). While waiting to be seen for their 2-week well-child visit, the parent will complete the Baseline Interview and be randomized to SG, IG, or CG. All participants will receive Standard of Care during all of their well-child visits, which will include standard anticipatory guidance delivered by the pediatric resident. The IG and CG interventions will be delivered in the clinic during the 2-week visit after the baseline survey has been completed. The first follow-up will be conducted at the home of the parent after completing the 2-week visit, when the baby is approximately 3-6 weeks old. The second follow-up will be conducted at the home of the parent after the 2-month well-child visit, when the child is approximately 2-4 months of age. Each home visit consists of an interview covering safe sleep and scald topics, an observation of the baby's sleep environment, and testing the water temperature. The 2-week and 2-month well-child visits will be audio-recorded, and parent or legal guardians will be asked to complete a Visit Exit Checklist.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years of age) or emancipated minor.
* Parent or legal guardian of the child.
* Child is receiving care at the Harriet Lane Clinic.
* Child's primary care provider is participating in the study.
* English-speaking.
* Lives in Baltimore City or Baltimore County.
* Not homeless or not living in a shelter or in an established transitional housing facility.

Exclusion Criteria:

* Not an adult or emancipated minor.
* Not the parent or legal guardian of the child.
* Child is not receiving care at the Harriet Lane Clinic.
* Child's primary care provider is not participating in the study.
* Non English-speaker.
* Does not live in Baltimore City or Baltimore County.
* Homeless or living in a shelter or other established transitional housing facility.
AKI Prevention and Early Intervention in Patients Undergoing VAD Placement

The investigators are doing this research to find out if more careful assessment and elimination of potential risk factors of acute kidney injury (AKI) during the subject's perioperative period will reduce their chance of kidney damage and kidney damage related problems.

The purpose of the study is to investigate whether preventive measures for patients undergoing ventricular assist device (VAD) placement will reduce AKI occurrence, progression and associated complications.

Participants will be in the study for a total of 6 days (1 day prior to the surgery and 5 days after the surgery). The investigators will review the participant's medical record up to one year after surgery.

The study investigators will access the participant's electronic medical record 24 hours prior to the planned VAD implantation and review the participant's medication regimen and provide recommendations to the participant's primary care physician in an effort to minimize potential risks for AKI. There will be no intervention during the operation.

The clinical recommendations will cover the following:

1. Avoidance of potentially nephrotoxic agents.
2. Optimizing volume status (avoidance of volume overload or depletion)
3. Optimizing electrolytes and acid-base status
4. Minimizing IV contrast exposure when appropriate
5. Treating severe anemia
6. Optimization of hemodynamics (Mean arterial BP\>65mmHg).

The investigators plan to compare the results of this study with the historical data in the same patient population in the years of 7/1/2015-6/30/2017.

Eligibility Criteria:
Inclusion criteria:

* Adult patients that will undergo VAD placement.
* Patients able to give consent

Exclusion criteria:

* Patients on dialysis (hemodialysis or peritoneal dialysis)
* Non-elective VAD placement (VAD implantation decision made within 24 hours)
Laser Treatment of Basal Cell Carcinoma Under Imaging Guidance

This pilot study will examine the treatment of basal cell carcinoma (BCC) with laser technology under the guidance of imaging modalities to assist with surgical excision, including optical coherence tomography imaging (OCT) and reflectance confocal microscopy (RCM). The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a nonablative laser already shown to effectively treat BCC. The addition of OCT and RCM has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. OCT is being used to enhance the effectiveness of Mohs Micrographic Surgery of these cancers by elucidating more definitive tumor margins. RCM has been shown to detect changes in the composition of cells consistent with BCC.

We propose to use these imaging devices to guide the laser treatment to achieve optimal efficacy with minimized side-effects. Primary outcome measured include complete clearance of the BCC lesion, which will be determined through clinical examination, dermoscopy, imaging (OCT and/or RCM), and saucerization biopsy. Secondary outcome variables include the significance of lesion depth (by OCT and/or RCM), lateral extent (by OCT and/or RCM), BCC type, and anatomical region on rate of clearance and recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* At least one (1) biopsy-proven superficial or nodular BCC, less than or equal to 2.0 cm in largest dimension
* Willing to have photographs taken of the treatment area
* Ability to understand and carry out subject instructions or be represented by a legally authorized guardian or representative

Exclusion Criteria:

* Pregnancy
* Patients with a BCC lesion that requires excision. This would include relatively large lesions (greater than or equal to \>2.0 cm diameter), lesions that penetrate deep into the skin beyond the depth of the OCT image capture, high risk lesions as defined by the American Academy of Dermatology as recurrent and sclerosing subtype BCC, or metastases.
* Subjects unable to follow-up for the full 12 months
* Subjects not willing to have biopsy taken from the treatment area
* Subjects with herpes simplex virus infection in treatment areas.
Interviews and Video Capture in Patients With GM1 Gangliosidosis

GM1 gangliosidosis is a rare disease for which there is a limited understanding of disease progression and meaningful outcome measures. In addition, parents report that clinic-based assessments are not always well-suited to capture all the disease features and other metrics that have an impact on the patient and family. To address the methodological challenges of this small, heterogeneous population, this study will collect patient-specific home-based video data and qualitative interviews with caregivers.

This is a natural history study, for up to 2 years, during which parents or guardians of a child with GM1 gangliosidosis collect video data of patients doing specific daily life activities at baseline and follow-up timepoints throughout the study (3, 6, 12, 18, and 24 months) and/or submit videos taken in the past through a secure smart phone mobile application. The video assessments focus on several hallmarks of GM1 gangliosidosis progression. Caregivers participate in qualitative interviews to provide context for the videos and discuss any changes they observe during the study. Activity videos will be evaluated by expert clinicians using both Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Change (CGI-C) scales. The caregiver interviews and clinician-rated activities will inform the patient-specific disease trajectories for each hallmark. There is no treatment or intervention associated with this study.

Eligibility Criteria:
Inclusion Criteria:

Be or have been the parent, legal guardian, or caretaker of a patient with GM1 gangliosidosis with:

1. Early infantile GM1 gangliosidosis
2. Late infantile GM1 gangliosidosis
3. Juvenile GM1 gangliosidosis who can walk with assistance or possesses past videos of when child could walk with assistance
4. Early or late infantile GM1 gangliosidosis who has passed away, but is in possession of videos documenting the onset and evolution of disease hallmarks of GM1 gangliosidosis

Exclusion Criteria:

GM1 gangliosidosis patient that the caregiver cares for is being treated with any experimental medication in a clinical trial setting.
Effectiveness of Proprioceptive Exercise in Neck Pain

Introduction: Neck pain is among the most common and costly for industrialized societies. It is difficult to know the exact structure causing the pain so most are considered as non-specific neck pain. There is a correlation between the alteration of craneocervical proprioception and neck pain. The evidence for treatment with proprioceptive exercises is very limited.

Objective: To know the efficacy of a proprioceptive exercise program for neck pain and to compare its effects with a cervical mobility program.

Materials and Methods: Subjects between 18-65 years old with non-traumatic neck pain are included. They will be randomized into two groups of exercises: proprioception or mobility, which will be developed over a period of two weeks, every day, with a total of 10 sessions per patient.


Eligibility Criteria:
Inclusion Criteria:

* Neck pain (NAD I-II) of recent onset (0-3 months)

Exclusion Criteria:

* Cognitive difficulties
* Lack of commitment to attend sessions
* Subjects with pacemakers or defibrillators
* Being receiving another physiotherapeutic treatment
* Other pathologies
Study 3 Learning Verbs and Pronouns

The goal of this research is to explore abilities to learn word meanings from overheard speech in children with ASD (and, as a control, typically developing children).

Specific Aim 3 (Experiment 3): Determine whether children with ASD can learn verbs and pronouns by overhearing. Most prior work on learning from overheard speech has focused on learning nouns that label objects. This experiment extends this work to study other kinds of words.


Eligibility Criteria:
Inclusion Criteria:

\* children with or without a diagnosis of ASD between 24 to 71 months of age

Exclusion Criteria:

* native language is not English
* born premature (\< 36 weeks)
* has uncorrected hearing or vision impairments
* has developmental disorders or medical conditions other than ASD that affect language or cognition (excepting psychiatric conditions often comorbid with ASD such as ADHD)
* has a history of photosensitive epileptic seizures
A Retrospective Study on the Effect of Surgery on Hip Diseases

To study the effect of arthroscopy on the treatment of hip diseases and to evaluate the regularity and treatment of hip joint diseases.

To study the clinical effect of arthroscopic treatment in patients with hip disease, a retrospective study was conducted on 600 patients with hip disease from January 2011 to January 2016. All patients underwent preoperative examinations. These included preoperative supine anteroposterior hip radiographs, cross-lateral radiographs, computed tomography (CT), and magnetic resonance imaging.Preoperative patient-reported outcomes (PROs), including visual analogue scale (VAS), international hip prognostic instrument-12 (IHOT-12), and modified Harris hip score (MHHS), were evaluated at 1, 2, and 5 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* The patient received imaging examination before surgery and was diagnosed with hip joint labrum injury, FAI and other hip joint diseases, and the patient complained of pain in the hip joint, buttocks or thigh. Conservative treatment is ineffective for more than 6 months.

Exclusion Criteria:

* History of hip surgery, hip osteoarthritis, femoral head necrosis, hip infection, rheumatic disease, lumbar disease, ankylosing spondylitis, or sacroiliac joint disease.
Psychological Intervention and Physiotherapy With Medication Improves CRPS Patients Outcome

A ten week open label study intervention to evaluate the outcome for a psychological intervention combined with physiotherapy and medication with memantine-morphine in 10 CRPS patients.

Ten CRPS I patients attended an intervention for 10 weeks. First, the medication was started with morphine 10mg adding gradually to 30 mg per day. Then, in addition to morphine, memantine 5 mg was started adding the dose gradually up to 40 mg per day if tolerated. Physiotherapy and psychological intervention were mostly carried out in a weekly group gathering with home exercises that were recorded to a diary. Psychological and physiotherapy interventions lasted for eight weeks. A neurological examination was done before and after the intervention as well as a separate physiotherapist examination of the hands. Patients filled out questionnaires of mood, quality of life, pain, and CRPS descriptions before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* CRPS type 1 for at least 6 months,
* pain NRS 4 or more

Exclusion Criteria:

* major psychiatric or neurological disease
A Food Effect Study of KC1036 in Healthy Subjects

The primary objective of the study was to assess the effect of High Fat Diet on the pharmacokinetics of KC1036 in Chinese adult healthy subjects.

This is an open-label, randomized, two cycle self crossover experimental design study to assess the effect of High Fat Diet on the pharmacokinetics, material balance, safety of KC1036 in Chinese adult healthy subjects. This study was divided into two Groups A and B.

Group A：In the fasting state, KC1036 po only once (60mg QD) and after 7 days, in the high fat diet state, KC1036 po only once (60mg QD).

Group B：In the high fat diet state, KC1036 po only once (60mg QD) and after 7 days, in the fasting state, KC1036 po only once (60mg QD).

Eligibility Criteria:
Inclusion Criteria:

* 18\~65 years of age, male.
* The weight of male subject ≥50kg, 19≤BMI≤26g/m2.
* Agree to take adequate contraceptive measures to prevent spouse pregnancy during the clinical trail.
* Able to comprehend and willing to sign an informed consent form (ICF).

Exclusion Criteria:

* Diseases such as liver, kidney, endocrine, cardiovascular, respiratory, nervous, mental, digestive tract, lung, immunity, skin, blood or metabolic disorders that are considered clinically significant by investigator, or have a history of these diseases, or have undergone major surgery, or factors that will endanger the safety of the subject or affect the research results.
* Physical examination, vital signs, laboratory examination, 12-ECG and chest film are clinically significant.
* Excessive smoking within 3 months before screening.
* History of drug and food allergy.
* Drinking 14 units of alcohol per week within 6 months prior dosing (1 unit = 360 mL of beer, or 150mL of wine).
* Participate in blood donate blood volume≥200mL or blood loss ≥200mL within 3 month prior dosing.
* Take any prescription, any over-the-counter medication, traditional Chinese medicines, vitamin products within14 days prior dosing.
* Take any clinical trial drugs within 3 months prior dosing.
* Dysphagia or history of gastrointestinal diseases affecting drug absorption.
* Combined with other viral infections (anti-HCV, anti-HIV positive, anti-TP positive, HBsAg positive) or combined with syphilis infection.
* Acute diseases requiring clinical treatment before screening or prior dosing.
* Anyone who refuse to stop ingest foods or drinks containing caffeine, alcohol from 48 hours before dosing to the end of the study.
* Urine drug positive or drug users within 3 months prior dosing.
* The investigator believes that the subjects are not eligible to participate in this trial.