cyrilzakka/clinical-trials huggingface dataset:
Feasibility Of Oral Sensorimotor Stimulation On Oropharyngeal Dysphagia In Children With Spastic Cerebral Palsy

Children with CP encounter swallow and feeding impairments, especially in infancy and childhood with long meal times with late development of oral motor skills resulting in poor growth.

this study will be conducted to explore the feasibility of oral sensorimotor stimulation combined with sequenced trunk co-activation on oropharyngeal dysphagia in children with spastic quadriplegic CP.

Eligibility Criteria:
Inclusion criteria

* Diagnosed as spastic quadrilepgic CP
* Both genders
* Aged from 12 to 48 months
* Scored ≤ 10 on an initial evaluation of Oral Motor Assessment Scale.
* Having at least a problem of oral motor functions (drooling, swallowing, and/or sucking); independent feeding
* Grade ≥ 2 spasticity according to the MAS
* Level IV and V motor function according to the GMFCS-R\&E.
* Partial head and trunk control. Exclusion criteria
* Gum and/or dental problems
* Congenital problems of mouth and soft plate
* Uncontrolled seizures
* Any metabolic disorders
* Cardiopulmonary disorders
* Significant mental problems.
QST, Blink Reflex and Nociceptive Flexion Reflex in Headache

The aim of this study is to compare central and peripheric sensitization in headache patients at Baseline (T0) and 1 month after (T1) a treatment with an anti-CGRP (Fremanezumab-Ajovy).

20 patients and 20 healthy subjects will be enrolled. The headache patients will be recruited just before starting their treatment and 1 month after (corresponding to the efficacy peak). Hot and cold stimulations will be delivered with the ATS probe from the Medoc Pathway on the forehead and on the hand (palmar face) to determine painful threshold to warm/cold stimuli. A blink reflex will be generated with a concentric electrode placed over the eyebrow and with active/earth electrodes linked to the EMG machine for the recording. For the nociceptive flexion reflex, a cutaneous stimulation will be applied on the arm and the response recorded on the corresponding muscles.

Eligibility Criteria:
Inclusion Criteria: patients with headache which are about to receive a treatment with fremanezumab

Exclusion Criteria:

* medication changes 1 month prior to the test
* neuropathy
* acute or chronic pain
* medications having effects on the central nervous system
* other disease
Sintilimab Plus Bevacizumab as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Curative Resection

This is an open label, multi-center, randomized, controlled phase III study, to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after radical resection

There is no stardard adjuvant treatment for HCC. This study is to to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after radical resection.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a first diagnosis of HCC who have undergone a curative resection
* Radiologic evidence of disease free ≥4 weeks after complete surgical resection
* Full recovery from surgical resection or post-operative transarterial chemoembolization before randomization
* Randomization needs to occur within 12 weeks of the date of surgical resection
* High risk for HCC recurrence as protocol defined
* Child-Pugh Score, Class A
* ECOG performance status 0 or 1
* No prior systemic anticancer therapy for HCC
* Adequate hematologic and organ function

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
* Evidence of residual, recurrent, or metastatic disease at randomization
* History of hepatic encephalopathy or organ transplantation
* Patients who are in the waiting list for liver transplantation
* Patients with Vp4 portal vein thrombosis
* Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy
* Pregnant or lactating women
Study of the Implementation of Telehealth-Supported LARC Provision in School-Based Health Centers

This is a prospective observational cohort study that will include SBHC patients at the 6 participating SBHCs who receive a telehealth reproductive health visit as part of their care. Information will be collected during patient interviews in the follow-up observation period regarding LARC initiation, satisfaction and continuation.

Aim 1. Quantify uptake of LARC (contraceptive implant, IUD) within the SBHC network following implementation of telehealth-supported LARC provision.

Aim 2: Describe the implementation of telehealth-supported long-acting reversible contraception (LARC) service provision in school-based health centers (SBHCs) using mixed methods.

Aim 3: Quantify LARC continuation, as in absolute continuation rate 12 months post-initiation, with analyses also examining continuation at 6 months follow-up period, among LARC initiators within the SBHC network following implementation of telehealth-supported LARC provision.

Aim 4: Compare continuation rates across dimensions of telehealth experience.

Long acting reversible contraceptives (LARCs) are safe and effective for adolescents, but low rates of use among this population and early discontinuation due to method dissatisfaction limits their potential to reduce unintended pregnancy. Reducing barriers for obtaining LARCs by adolescents who want to use them is key in reducing risk of unintended pregnancy. Data will be collected from patients who are receiving same-day LARC as a part of their normal care via telehealth services in school-based health centers (SBHCs). This implementation model, therefore, has the potential for replication and scale-up with wide reach. The findings from this study, given the SBHC setting, have the potential to inform and improve LARC service delivery for adolescents far beyond New York City and the SBHC setting.

Eligibility Criteria:
Inclusion Criteria:

* an enrolled patient at the participating SBHC
* age 13-22 years
* female
* had a visit at the SBHC during the study period that is coded as a "reproductive health visit" including contraceptive counseling, contraceptive management, and contraceptive method initiation

Exclusion Criteria (specifically for Aims 2 and 3):

* are younger than age 13 years
* are older than age 22
* are not an enrolled patient of the participating SBHCs
* did not initiate a LARC method
* are a person without a uterus
* are unable to read, speak, and understand either English or Spanish
The Individually Marked Panretinal lasEr phoTokoagUlation for Proliferative Diabetic Retinopathy Study - DETECT

The purpose of this study is to determine the threshold level of proliferative diabetic retinopathy progression and regression after standard panretinal photocoagulation. Predictors of progression and regression will be identified which will include retinal vessel geometry (caliber, fractals and tortuosity), retinal vessel oxygen saturation and retinal areas of non-perfusion.

IMPETUS 2018 - DETECT is a six-month prospective study involving 90 treatment-naïve diabetes patients with proliferative diabetic retinopathy (PDR) referred for panretinal laser photocoagulation (PRP) treatment to the Department of Ophthalmology, Odense University Hospital between July 1st 2014 and June 30th 2015.

Project information will be given prior to the study to the ophthalmological departments of and to all private practicing ophthalmologists in the Region of Southern Denmark. Patients will at baseline have a standard examination that will include wide-field fundus photography, wide-field fluorescein angiography and spectral domain optical coherence tomography (SD-OCT) in order to confirm the diagnosis of PDR. If they meet the criteria of inclusion and not those of exclusion, they will be informed of the study verbally and writing and offered the chance to participate. Prior to the first session of PRP patients enrolled in the study will receive the rest of the baseline examinations including retinal oximetry. Standard PRP treatment will be given in two sessions by a trained doctor.

Patients will be re-examined at month 3 and 6 and progression/regression of PDR will be evaluated by measuring the amount of fluorescein leakage by wide-field fluorescein angiography at 1, 5 and 10 minutes. For patients with regression, supplementary PRP will be offered. After the final examination at month 6, patients will be referred back to their primary ophthalmologist.

A study nurse and a photographer will be assigned to the project. All examinations will be standardized and the study crew will be fully certified. Data will be analyzed with respect to the endpoint of the study (Stata 13, StataCorp, College Station, Texas) and also used to create the algorithm to be used for individualized treatment in IMPETUS 2018 - TREAT.

In the Region of Southern Denmark it is estimated that 200 treatment naïve patients with PDR will be referred for treatment annually. With an estimated participation rate of 50% and a subsequent dropout rate of 10%, IMPETUS 2018 - DETECT will include 90 patients. A traditional power calculation is not feasibly due to the design of the study with multiple outcomes studies.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus
* Proliferative diabetic retinopathy of one or both eyes

Exclusion Criteria:

* Diabetic macular edema on current eye
* Earlier PRP treatment on current eye
* Cataract demanding treatment on current eye
* Pregnancy
Study to Estimate the Point Prevalence of Peripheral Intravenous Catheter-related Complications in Brazil

A multi-center, national prevalence study where: (1) baseline SPIVC therapy complications of hospitalized adult patients that meet the inclusion/exclusion criteria of the study and (2) the compliance of clinicians to the Hospital's evidence based practice will be measured in Brazil.

At each participating research site, select nurse clinicians who are experienced or experts in short peripheral I.V. catheter (SPIVC) therapy, will audit medical records and observe the SPIVC sites of adult patients in various hospital wards until a minimum total of 300 SPIVC sites are audited among 3 Brazilian acute care hospitals. The wards audited will be selected by the Investigator and will be audited during a specified time period until at least 100 SPIVCs are audited. The time to complete the study will depend on the size of the select wards, the number of nurse auditors and the number of monitoring visits required.

There are no treatments. The short peripheral I.V. catheter-related medical devices (products) observed during the study are currently approved by Brazil regulatory agencies, purchased by the hospital and available to the clinician at the time of the study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject, aged 18 years or older at the time of the study's audit of the ward;
* Subject admitted into one of the wards audited at the study site;
* Subject available for observation at the time of the audit;
* Subject with at least one inserted PIVC;
* Subject that voluntarily signed and dated the informed consent form (ICF) prior to study entry, if required by the study site's Ethics Committee.

Exclusion Criteria:

* Subject under treatment at the study site's outpatient clinics;
* Subject admitted into a mental health ward, emergency ward or burn unit;
* Subject awaiting transfer to another facility.
Lymphedema Therapy With Sound Wave Lymphatic Drainage

Lymphedema is a frequent sequela of breast cancer treatment, that can develop up to 40% of patients. Lymphedema is the accumulation of protein-rich fluid (lymph) in the interstitial spaces of the affected body part due to a blockage or malfunction in the lymph system. It can appear in the arm, shoulder, breast, or thoracic area. Lymphedema swelling causes discomfort and sometimes disability. The treatment of lymphedema associated with breast cancer can include complex decongestive physiotherapy, compression therapy, therapeutic exercises, and pharmacotherapy.

In this study two treatments will be compared to reduce lymphedema: the manual lymphatic drainage (standard care) versus the low frequency sound waves.

Lymphedema, a sequela of breast cancer and breast cancer therapy, changes functional abilities and may affect a patient's psychosocial adjustment and overall quality of life. Lymphedema is the accumulation of lymph fluid in the interstitial space. Fluid accumulation in the limbs causes enlargement, often with a feeling of heaviness.Chronic inflammation leads to fibrosis of the lymphatics, which compounds the problem. Several studies have examined the incidence of lymphedema when axillary radiation is given after axillary dissection vs radiation to an undissected axilla. The risk of lymphedema is higher in women treated with axillary dissection and adjuvant radiation to the axilla, with edema reported in 9% to 40% of patients. Patients with lymphedema may report symptoms such as a sensation of arm fullness and mild discomfort, which are seen in the early stages of the condition. Joint immobility, pain, and skin changes are noted frequently in the later stages of lymphedema. Patients also may be predisposed to infections involving the affected extremity. The treatment of lymphedema associated with breast cancer can include complex decongestive physiotherapy, compression therapy, therapeutic exercises, and pharmacotherapy. Manual lymphatic drainage is the standard decongestive therapy. Recently, low frequency sound waves has been used to reduce lymphedema. The aim of this study is to compare the efficacy of the manual lymphatic drainage versus the low frequency sound waves.

Eligibility Criteria:
Inclusion Criteria:

* Lymphedema presence at least for 1 year
* No previous treatments for lymphedema in the last 6 months

Exclusion Criteria:

* Electronic devices or metalic implants
* Cardiac failure or hypertension
* Epilepsy
* Local infection
* Pregnancy
* Thrombophlebitis
Body First Approach in Lap Cholecystectomy in Cases With Obscure Calot's Triangle

The aim of this study is to evaluate the body first approach on the rate of conversion to open technique \& VBI in patients with obscure calot's triangle.

Gallbladder disease is one of the most common reasons patients are referred to a general surgeon. Laparoscopic cholecystectomy (LC) is the current standard of care for symptomatic cholelithiasis. Despite being considered a low-risk surgery, bile duct injuries (BDIs) have occurred at a constant rate in the last 30 years, leaving devastating consequences on the affected patients. However vasculobiliary injury (VBI) is a rare but critical complication of (LC). So we need to follow critical view of safety. The critical view of safety (CVS) described by Strasberg is considered as the one of the most important critical factors for overall safety during LC. The CVS consists of three essential component or steps: 1) dissection of the hepatocystic triangle (HCT); 2) exposure of at least lower one third of the cystic plate (CP); and 3) demonstration of only two tubular structures (cystic duct and cystic artery) that remain attached to the gallbladder (after components 1 and 2 are achieved). All these three steps must be completed before considering that CVS has been achieved. However in some cases Calot's triangle can't be demonstrated due to dense adhesions. Conversion with retrograde approach (fundus first) was an option for these cases. However a retrograde approach can be achieved laparoscopically by starting dissection by body to use the fundus attachment for retraction which is called (the "body-first approach") that may decrease the possibility of VBI. Recent studies deficient in evaluation of outcome of (body first approach). So the interest of our study is to evaluate the outcome of body first approach in difficult cases and cases with obscure Calot's triangle in (LC) and to evaluate its feasibility and safety in (LC).

Eligibility Criteria:
Inclusion Criteria:

- All adult patients aging above 18 years old fit for (LC), who presented with symptomatic gall stones by clinical examination and detected by preoperative imaging and intra-operatively have obscure Calot's triangle.

Exclusion Criteria:

* unfit patients.
* Patients with calcular obstructive jaundice.
Single Dose Pravastatin Pharmacokinetics in Pediatric Peritoneal Dialysis Patients

Many children with end stage renal disease develop hyperlipidemia. HMG-CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors, such as pravastatin, are typical treatments for hyperlipidemia. However, we do not know how pravastatin is metabolized in patients on dialysis. This study is designed to provide preliminary pharmacokinetic data for pravastatin in pediatric patients on peritoneal dialysis.

This is a single-dose pilot study to evaluate the pharmacokinetic profile of pravastatin in 7 pediatric and adolescent subjects ranging from 12 months to 16 years of age who are on dialysis. The study group will be comprised of healthy children receiving continuous cycling peritoneal dialysis (CCPD). Pravastatin dosing will be 10 mg in all subjects. Blood, urine, and dialysate samples will be obtained over a 24-hour period post-dose for measurement of pravastatin concentrations. Safety evaluations will include adverse events (AEs), physical examination, vital signs, and clinical laboratory evaluations.

Eligibility Criteria:
Inclusion Criteria:

1. Patients from 12 months to 18 years of age.
2. Patients with end stage renal disease who receive continuous cycling peritoneal dialysis.
3. signed informed consent
4. Physical exam demonstrates no abnormalities that would make this study medically hazardous to the subject.

   -

Exclusion Criteria:

1. Any clinically significant unstable medical condition or chronic disease other than those associated with ESRD.
2. Any clinically significant illness within 10 days or receiving single-sdoe of study medication
3. History of rhabdomyolysis
4. Clinically significant liver disease or history of malabsorption or previous gastrointestinal surgery that could effect drug absorption or metabolism.
5. Clinical laboratory abnormalities: Aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine phosphokinase(CPK) \> 2.5 times upper limit of normal; hemoglobin \< 8.5 g.dL.
6. Known hypersensitivity to pravastatin
7. Unwilling to have blood samples drawn
8. Has taken a HMG-CoA reductase inhibitor in the last week -
CV Events in Emetogenic Chemotherapy

Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in IHCIS in 2006
* At least one HEC or MEC claim in 2006

Exclusion Criteria:

* HEC or MEC claim three months before first HEC/MEC claim - "wash-in" period (i.e. must be enrolled for three months prior to first HEC/MEC claim. For patients whose first HEC/MEC event is between January 1,2006 and March 31, 2006, enrollment criteria for inclusion in the study may extend as far back as October 1, 2005)
* HEC or MEC claims prior to 45 days after last HEC or MEC claim - "wash-out" period. (For patients whose last claim in 2006 was seen after December 1, 2006 enrollment into 2007 to look for further treatment and the 45 day "wash-out" period will be required.)
Medication Adherence Monitoring Trial Using Smart Clinical Trial Application and Smart Watch

The study will investigate the effect of smart monitoring on medication adherence.

In this study, multiple medication monitoring procedures will be performed: self-reporting, pill counting, smart monitoring and concentration monitoring. Subjects will take vitamin D supplement on the market which enables validated concentration monitoring. The study will last for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 19-64 years at the consent
* 25(OH) vitamin D \< 10 ng/mL
* Not taking vitamin D at the screening
* Fully understood the study procedures

Exclusion Criteria:

* Hypercalciuria, sarcoidosis
* Clinically significant hypersensitivity reaction to Vitamin D
* History of or current kidney stone
* One of the following findings:

  1. Serum calcium level \> upper limit of normal
  2. Estimated glomerular filtration rate \< 60 mL/min/1.73m\^2
* Galactose intolerance, Lapp lactase deficiency, Glucose-galactose malabsorption
* Unable to use smart clinical trial application or smart watch
* Expected to take vitamin D from 4 weeks before the first administration and until the last administration
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons with Tetraplegia

The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.

The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders
* Complete or incomplete tetraplegia (quadriplegia)
* Must live within a three-hour drive of the Study site
* (There are additional inclusion criteria)

Exclusion Criteria:

* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
* Chronic oral or intravenous steroids or immunosuppressive therapy
* Other serious disease or disorder that could seriously affect ability to participate in the study
* (There are additional exclusion criteria)