cyrilzakka/clinical-trials huggingface dataset:
Effects of Control Scan for Presumed Difficult Epidural Infiltrations (ECHORACHIS)

The aim of this care protocol is to study the effects of scan to help epidural infiltration realization, in presumed difficult patients suffering from sciatica.

These scans are already performed in our Rheumatology Department but our objective is to evaluate objectively its contribution for patients and doctors.

Epidural infiltration in young patients, with an easy anatomical identification, causes generally no technical difficulties, therefore this protocol will only include patients presumed to have a difficult infiltration, that means those aged more than 60, and/or with BMI \> 30 and/or suffering from scoliosis.

This study concerns patients who are hospitalized in Rheumatology Department (Hospital of Nantes) for their first epidural infiltration for treatment-resistant lombosciatica.

Patient will be randomized at Day 0, before infiltration. This latter will be performed in accordance to current practice.

Tolerance data (pain and satisfaction) will be collected just after the infiltration and eventual complications will be reported within 48 hours after infiltration.

Following treatment of lombosciatic will be realized through hospitalization, as usual.

Scan is a safe, non invasive, painless and non radiating exam. It is the extension of the musculoskeletal clinical exam and it has already changed our rheumatology practices. The investigators hope at the end of this study, that results would confirm that scan can be a help in practice to perform epidural infiltrations.


Eligibility Criteria:
Inclusion Criteria:

* Major patients hospitalized in Rheumatology Department for performing their first epidural infiltration when sciatica is resistant to medical treatment.
* Inclusion of patients older than 60 years and / or BMI superior to 30 and / or scoliosis

Exclusion Criteria:

* Refusal to participate
* History of spinal surgery
* Anticoagulant or antiplatelet
* History of spinal malformations type spina bifida
* pregnancy
* Age\<18
* Patients under guardianship
* Patients participating to another clinical trial (except non interventional trials)
* Patients unable to achieve the protocol, in the judgment of the investigator
Safety, Tolerability and Efficacy of ICV AX 250 Treatment in MPS IIIB -OLE

This is a Phase 3B/4, multicenter, multinational, open label study to further evaluate intracerebroventricular (ICV) delivered AX 250 treatment in MPS IIIB subjects that complete Study 250-202 for up to an additional 3 years (144 weeks) of treatment with AX 250 administered by ICV infusion every other week. Subjects will be evaluated for neurocognitive function, communication, adaptive behavior, quality of life, imaging characteristics and biochemical markers of disease burden. Safety will be assessed by adverse events, clinical labs, and physical exams.


Eligibility Criteria:
Inclusion Criteria:

1. Must have completed 240 weeks of Study 250-202 and enter 250-401 within 8 weeks of dosing completion.
2. Provides written informed consent from parent or legal guardian and assent from subject, if required
3. Has the ability to comply with protocol requirements in the opinion of the investigator
4. If female with childbearing potential, must have a negative pregnancy test at the Screening visit and be willing to have additional pregnancy tests during the study

Exclusion Criteria:

1. Has (1) a cognitive age equivalent (AEq ) score ≤ 18 months, (2) a development quotient (DQ) score ≤ 20, and (3) no evidence of improvement during the 250-202 study in secondary or exploratory efficacy endpoints
2. Would not benefit from enrolling in the study in the opinion of the investigator
3. Has received stem cell, gene therapy or enzyme replacement therapy (other than AX 250) for MPS IIIB
4. Has a history of poorly controlled seizure disorder
5. Is prone to complications from ICV drug administration including patients with hydrocephalus or ventricular shunts
6. Has received any investigational medication within 30 days prior to the Baseline visit or is scheduled to receive any investigational drug during the course of the study
7. Has a medical condition or extenuating circumstance that, in the opinion of the investigator, might compromise the subject's ability to comply with protocol requirements, the subject's well-being or safety, or the interpretability of the subject's clinical data
Feasibility of Aerodigestive Stimulation Therapy Trial

The goal of this study is to demonstrate safety, feasibility, and efficacy of a novel pharyngo-esophageal stimulation technique in restoring aerodigestive and swallowing functions in select infants at-risk for chronic gavage tube feeding or gastrostomy. The main aims are:

* To provide consistent activation of deglutition (the process of swallowing), swallowing-airway interactions, and peristalsis in order to decrease the risk of home tube feeding.
* To examine whether physical and manometric evidence-guided interventions and biofeedback will improve compliance, minimize parental stress, and increase satisfaction and perceived self-confidence with infant feeding.

Participants will have weekly pharyngo-esophageal stimulation guided by High Resolution Impedance Manometry (HRIM) for 4 weeks or until discharge, oral nutritive stimulation of at least 5 mL of prescribed milk with each feed, and weekly parental education and feedback regarding feeding progress.

Stimulation will be provided to the esophagus using esophageal manometry starting at enrollment and then weekly for 4 weeks or until discharge, whichever occurs first. During the 4 weeks of study enrollment, subjects will also be provided nutritive oral feeding therapy with each care with a minimum of 5 mL of their prescribed feed. Feeding evaluations by a study team member will occur once a day during the length of the 4-week trial. The study team will do weekly rounds at the bedside to evaluate feeding progress and study interventions. A feeding plan will be posted at the bedside for clear communication with the care team and family of the subjects.

Eligibility Criteria:
Inclusion Criteria:

* NICU infant ≥37 weeks postmenstrual age not taking full oral feeds
* Consult to Neonatal \& Infant Feeding Disorder Program for oral feeding difficulty with diagnostic manometry ordered
* Presence of peristaltic and sphincteric reflexes at initial manometry

Exclusion Criteria:

* Potentially lethal chromosomal anomalies
* Craniofacial malformations
* Foregut malformations
Effectiveness of a Parent-mediated Intervention with PACT on Children with ASD

Autism Spectrum Disorder (ASD) is a neuro-developmental disorders. There are different types of interventions. Among these interventions Early Start Denver Model (ESDM) and Preschool Autism Communication Therapy (PACT) have proved efficacy at short and long term. PACT is the therapy with the highest evidences when Parents delivered the intervention themselves.

In PACT, parents are guided, generally in face to face, by a professional to improve the synchrony and communication with their children with ASD. Then, it is recommended to the parents to practice the therapy daily at home. In France, this type of early intervention is poorly developed and is only accessible in specialized centers located in large urban centers. Guiding parents by videoconferencing could make this intervention accessible to families in undeserved areas. The objective of this study is to evaluate the effectiveness of a PACT intervention delivered by parents and guided by videoconferencing, on the autism in their children with ASD, aged 18 to 36 months at the inclusion.

This is a mixed (quantitative and qualitative), multicenter, controlled, randomized, open-label study, comparing a group of children receiving usual care and one of whose parents is trained and accompanied by videoconferencing to developmental techniques as described in the PACT, to a group of children benefiting only from the usual care provided by the community. The primary endpoint was the severity of autism measured with the ADOS-2 (2012 Autism Diagnostic Observation Schedule) severity score (CSS) at 12 months. A total of 212 children will be included in the study (106 / group).

Eligibility Criteria:
Inclusion Criteria:

Child with autism Spectrum disorder

* Symptoms in autism with a severity superior to 4 as measure by ADOS-2
* Positive ADI (Autism Diagnostic Interview)
* Diagnostic done by a multidisciplinary team
* Nonverbal IQ above 12 months Having health assurance

Exclusion Criteria:

For the child

* Child with a twin brother or sister with ASD or having a brother or sister already included in this study
* Epilepsy requiring medication
* Severe hearing or visual impairment
* Identification of a genetic anomaly causes participation in the intervention or validity of the data (determined by the principal investigator on a case-by-case basis)

For the parents

* Severe hearing or visual impairment
* Severe psychiatric disorder
* Unstable somatic disorders preventing intervention
* Lack of Internet access
* Parent not available for regular follow-up
* Opposition of one parent to the child's participation in a study
* Already receiving PACT therapy or any other intensive intervention (e.g. Denver)
Spinal Versus General Anesthesia on Postoperative Pulmonary Complications

The objective of this study was to investigate the difference in postoperative pulmonary complications (PPCs) between spinal anesthesia and general anesthesia in patients undergoing delayed hip surgery.

In this study, the difference of 30 min arterial partial pressure of oxygen after operation was used as the main outcome index. By means of pulmonary ultrasound, pulmonary function monitoring and other physical and biochemical examinations, the difference of postoperative pulmonary complications between spinal anesthesia and general anesthesia in patients with delayed operation of hip fracture longer than 48 hours was compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 65 years old
* ASA Class I \~ III
* Surgical repair of femoral neck, intertrochanteric or subtrochanteric fractures
* The time from diagnosis to surgery is more than 48 hours

Exclusion Criteria:

* Unable to walk about 3 meters or across a room without assistance before the fracture
* Emergency surgery
* Congestive heart failure, asthma, anemia (Hb \< 90 g/L), hypoalbuminemia (ALB \< 35g/L)
* Abnormal coagulation function
* Severe aortic stenosis
* Injection site infection or increased intracranial pressure
* Patients have participated in previous trials or have been determined by a surgeon or anesthesiologist to be unsuitable for randomization
* The written informed consent of the patient or his/her representative cannot be obtained
Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess the efficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Completed the SH-NEN-0001 study with relief of upper GI symptom. Relief is defined as "last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to be rated as Mild during the 7-day period".
* A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily NSAID treatment for at least 6 months. Daily NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose NSAIDs.
* Daily NSAID treatment dose and type: (Must have been stable for at least 9 weeks prior to inclusion and; Are expected to remain stable for the duration of the study. and; Must be administered orally. If more than one type of NSAID treatment is used, at least one type must be administered orally).
* Hp negative on Histology performed at baseline endoscopy in the study SHNEN- 0001.

Exclusion Criteria:

* Discontinuation from study SH-NEN-0001
* Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation.
* Pain, discomfort or burning in the upper abdomen not associated with the use of NSAIDs, including COX-2 selective NSAIDs.
* Pregnancy or lactation. Women of childbearing potential must maintain effective contraception during the study period as judged by the investigator.
* Need for continuous concomitant therapy with: (Anticoagulants; Corticosteroids at doses higher than explained under inclusion criterion)
Stimulation of Sensation and Improvement in Swallowing Using Oral Capsaicin

This is a research study to learn more about whether capsaicin, a natural ingredient of chili peppers that makes them taste "hot", can improve swallowing function. The purpose of this study is to evaluate whether sucking on a capsaicin lozenge improves sensation in the throat enough to improve swallowing function.

Swallowing problems are encountered frequently in primary practice and in the hospital setting. The list of possible causes is large, ranging from strokes and neurological disease through to complications of cancer treatment, acid reflux, and surgery. Many patients have a reduced ability to feel food and fluid (reduced sensation) within the throat (pharynx) and this leads to inability to manipulate food and fluids in the correct manner. This can produce a variety of swallowing problems such as choking on foods and fluids, regurgitation, aspiration, weight loss, malnutrition and poor quality of life.

Treatment is largely directed at rehabilitation of muscle power and education about safe swallowing techniques or positioning that limits food and fluid entering the airway. A novel approach is to try to improve sensation within the pharynx so that patients can feel substances present and then manipulate them in a more appropriate and safe manner. In this regard capsaicin, a nutritional supplement derived from peppers, has shown a stimulatory effect on sensory nerves and an ability to improve the swallowing reflex (Ebihara et al., 2005). Although studies have shown that capsaicin can improve the swallowing reflex, data regarding improvement in swallowing function is lacking. Using a small dose of capsaicin administered as a lozenge, we hope to stimulate sensation within the pharynx enough to improve physical swallowing measures on a contrast swallow study. This method of application is comfortable, easy and directed to the site of action.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years of age
* Patients with the following condition: dysphagia, globus, gastroesophageal reflux, neurological disease affecting swallowing or any other condition requiring dynamic swallow study
* Patients willing to provide written informed consent for their participation in the study

Exclusion Criteria:

* Patients unable to complete a full dynamic swallow study protocol
* Patients enrolled in another investigational clinical trial that interferes with any testing or testing results
* Patients who are pregnant
* Patients with known sensitivities or allergies to capsaicin or peppers, or nightshades (tomato, bell pepper, eggplant) or latex
* Patients who are prisoners
* Patients who are unable to keep a capsaicin lozenge in their mouth safely for 5 minutes
To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3)

This study is a multicenter, Randomized, Open-label, Parallel, Phase 3 Clinical Trial in 8 weeks for screening, once Investigational product injection, Follow up visit.

The purpose of this study is to evaluate the efficacy and safety of LuminoMark inj. (Conc. for fluorescence) localization in patients with nonpalpable breast lesions.

Eligibility Criteria:
Inclusion Criteria:

1. 19 years ≤ age ≥ 80 years
2. Those who have lesion vial mammography and breast ultrasound
3. Those who be expected to do operation about non palpable breast lesion excision
4. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. Patients who be expected to do mastectomy
2. Patients with multiple tumor or diffuse microcalcification
3. Patients who have ink on invasive cancer or ductal carcinoma in situ despite 3 times local resection
4. Patients who were treated with moderate to severe radiotherapy
5. Patients who were treated with neoadjuvant Chemotherapy
6. Patients with active invading skin connective tissue disease
7. Patients with local progressing breast cancer or inflammatory local progressing breast cancer
8. Patients who have an allergy to investigational product or any of the component with the Investigational product
9. Patients who disagree about contraception for this clinical trial
10. A pregnant women or lactating women
11. Patients who participated in other clinical trials within the past 12 weeks from the date of informed consent
12. Patients who investigators determines unsuitable for this clinical trial
The Effect of Resistance to Participant-Supported Reaching on Workspace of the Hand in Severe Chronic Stroke

Disturbances in movement coordination are the least well understood but often the most debilitating with respect to functional recovery following stroke. These deficits in coordination are expressed in the form of abnormal muscle synergies and result in limited and stereotypic movement patterns that are functionally disabling. The result of these constraints in muscle synergies is an abnormal coupling between shoulder abduction and elbow flexion (i.e. the flexion synergy), which significantly reduces the reaching function of an individual with stroke when they lift up the weight of the impaired arm against gravity. The investigators previous neurotherapeutic research, supported by a NIDRR Field Initiated research grant, has shown that the abnormal synergy between shoulder abduction and elbow flexion can be significantly reduced thus increasing total reaching range of motion in individuals with severe stroke. The previous work established progressive abduction loading as a key element to the rehabilitation of reaching. Although individuals with severe stroke benefited from the investigators previous work, residual flexion synergy continued to hinder normal arm function in most participants with severe stroke. This study will utilize the ACT3D robot, developed as part of the investigators previous NIDRR project, to incorporate resistance to reaching while accounting for the known benefits of progressive abduction loading. The investigators propose to randomize forty participants with severe stroke into two closely related interventions. The groups will both practice reaching under abduction loading, however, the experimental group will also move against resistance while reaching. Rigorous and quantitative investigation of therapeutic elements such as resistance to reaching and progressive abduction loading is only possible with a device such as the ACT3D. the investigators will be able to standardize the delivery of each intervention using kinematic and kinetic parameters, which will allow for a clear identification of the therapeutic effect of resistance to reaching. the investigators hypothesize that resistance to reaching in combination with progressive abduction loading will further increase dynamic multi-joint strength, increase total reaching range of motion, and increase arm function thus enhancing actual amount of use of the arm, participation in life roles, and quality of life in individuals with severe stroke.


Eligibility Criteria:
Inclusion Criteria:

* Paresis confined to one side, with substantial motor impairment of the upper limb
* Absence of motor impairment in the unimpaired limb
* Absence of severe concurrent medical problems (e.g. cardiorespiratory impairment, changes in management of hypertension)
* Absence of any acute or chronic painful condition in the upper extremities or spine
* Absence of hemineglect
* Capacity to provide informed consent.
The Influence of Trust in the Health Care System on Postpartum Contraceptive Choice

The purpose of this research is to understand the relationship between trust in the health care system and choice of contraception during the postpartum period among pregnant women receiving prenatal care.

Research subjects will complete a questionnaire at enrollment and between delivery and within 5 days of hospital discharge.

A chart review will also be completed to gather use of a birth control method at the six week postpartum visit as well as pertinent medical diagnoses and recorded data such as height, weight, body mass index, and contraceptive plan as documented in the postpartum medical chart.

The aims of the proposed research are three-fold:

1. To identify whether trust in the health care system is associated with choice of the highest efficacy contraception (intrauterine contraception, implantable contraception, and sterilization) in the immediate postpartum period among pregnant women receiving prenatal care.
2. To explore which patient-level factors (sociodemographic, reproductive history, future pregnancy intentions) and provider-level factors (antenatal contraceptive counseling) are associated with choice of the highest efficacy contraception in the immediate postpartum period among pregnant women receiving prenatal care.
3. To determine whether trust in the health care system is altered during the receipt of prenatal care or delivery.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant Women receiving prenatal care at Medical University of South Carolina (MUSC)
* Age 18 or older

Exclusion Criteria:

* Greater than 20 weeks gestation