cyrilzakka/clinical-trials huggingface dataset:
Non-phonatory Exercises in Patients with Unilateral Vocal Fold Paralysis Post-thyroidectomy

Thyroidectomy is the most common iatrogenic cause of vocal fold paralysis. Patients complain of hoarseness caused by incomplete glottic closure and have effort to raise vocal intensity with consequent elevation of the larynx and/or involvement of supraglottic structures in phonation. These compensation mechanisms result in a shift of the fundamental frequency towards more serious tones or falsetto voice emissions.

The first choice treatment is speech therapy which aims to obtain better glottic closure, preventing ankylosis of the crico-arytenoid joint. In order to promote better glottic closure without risking the onset or increase of dysfunctional compensation, the idea behind this project is to propose non-phonatory adduction exercises in the first post-operative week.

The primary objective of the study is to compare patients who will perform non-phonatory exercises in parallel with medical therapy for one week and patients who will perform standard medical therapy only during the first week.


Eligibility Criteria:
Inclusion Criteria:

* vocal fold paralysis after thyrodectomy
* ability to sign an informed consent

Exclusion Criteria:

* Vocal fold paralysis with different etiology
* Previous history of laryngeal, pulmonary or gastric surgery
* History of vocal or laryngeal pathologies that have required therapy
* Current or previous lung disorders
* Hearing loss
* Motor or neurological deficits
* Presence of malignant diseases
* Presence of speech or reading disorders
Evaluation of the Relevance of Comparative Genomic Hybridization in Prenatal Diagnosis

Pre-natal diagnosis is developing nowadays thanks to the improvement of ultrasound performances but also of genetic analysis techniques.

The karyotype was previously the reference technique for genetic analysis. The development of comparative genomic hybridization, consisting of comparative genomic hybridization on DNA sequences and allowing the diagnosis of unbalanced chromosomal rearrangements, has made it possible to increase the resolution threshold for the detection of genetic anomalies. This technique can be performed both pre and post natal. In pre-natal, the indications for this genetic study are based on ultrasound signs and are regularly updated in the international literature. Due to the complete analysis of the genome and the increase of the resolution threshold, genetic anomalies not related to the detected ultrasound pathology may be discovered and may pose ethical problems from a genetic counseling point of view.

To date, the diagnostic performance of comparative genomic hybridization as a complement to karyotype is being confirmed and needs to be clarified in order to limit the risk of incidental discovery of genetic anomalies whose significance remains unknown.

Through the study that the investigator would like to carry out, the investigator seek to evaluate the diagnostic contribution of this comparative genomic hybridization technique compared to the data provided by the karyotype according to the various ultrasound call signs on the Nancy cohort of files presented to the multidisciplinary pre-natal diagnosis committee, since the launch of the comparative genomic hybridization in Nancy in 2012 until 2018.


Eligibility Criteria:
Inclusion Criteria:

* CGH-array performed for ultrasound findings at the genetic laboratory of the Nancy University Hospital from 01/10/2012 to 31/12/2018
* Results of the CGH-array presented to the multidisciplinary pre-natal diagnosis committee of Nancy

Exclusion Criteria:

* patients who objected to the use of their data for research purposes when signing the informed consent form given during the genetic consultation
Effect of Oral Choline Supplementation on Postoperative Pain

This research will test whether consuming additional choline before gynecological surgery decreases postoperative pain.

More than 70% of the patients undergoing surgery in the USA, experience moderate to severe pain after the surgery in spite of being treated for pain. We will test whether choline will produce an effective additional analgesic action for postoperative pain treatment. Choline and lecithin are safe and are available for consumers as over-the-counter nutritional supplements. Choline supplementation decreases postoperative pain in rodents. Also Nicotine decreases postoperative pain in humans and since choline acts on the same receptors as nicotine, choline supplementation may be effective as an analgesic without the risks of addiction and the side effects like high heart rate and blood pressure.

Sixty women between the ages 18 and 60 undergoing open abdominal gynecological surgeries will be studied. We will not study people with chronic pain, drug abuse, and/or nicotine use over the past six months, current pregnancy or breastfeeding, allergy to soy, or inability to take any drug that we will use in the study.

Patients will take 10 tablets (choline or gelatin powder placebo) the night before surgery. After anesthesia, a second dose will be given into a tube that goes into the patient's stomach. One tablespoon of blood (15 mL) will be drawn five times to measure genetics, changes in levels of plasma choline and inflammatory markers: blood will be drawn at the preoperative visit, three times on the day of surgery and once 24 hours postoperatively. At 24 hours after surgery and on their follow-up visit with their doctor, the patient's surgical wound will be photographed and patients will complete a survey on satisfaction with treatment.

Primarily we are looking at the pain scores after surgery and secondarily at the pain medication use, plasma choline levels, wound healing and satisfaction with pain treatment.

This is a randomized double blind study. Patients will consume ten tablets (10g choline or placebo) the night before undergoing gynecological surgery and 10 tablets the morning of surgery. We will measure pain after surgery, baseline and postoperative plasma choline, and test genetics.

Eligibility Criteria:
Inclusion Criteria:

* open pelvic surgery
* able to swallow pills

Exclusion Criteria:

* chronic pain
* opioid use
* pregnancy
* lactation
Components of Chlorhexidine Gluconate Dressing

The purpose of this study is to determine the contents of a chlorhexidine-containing dressing after use.

To characterize the chemical composition of the CHG (2% CHG) Catheter Dressing Patch as compared to Biopatch Protective Disk with CHG, and Tegaderm IV (intravenous) Securement Dressing over a wear period of 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Able to read, review and sign the Informed Consent
* Willing to shower using the same soap/cleansers from the Screening Visit through the end of the study
* Use study-approved contraceptive methods

Exclusion Criteria:

* Participation in an investigational study within 28 days prior to dosing.
* Clinically significant illness within 28 days prior to dosing.
* History of allergic responses to chlorhexidine, chlorhexidine-containing products, glycerol, adhesives, latex
* History of clinically significant skin disorders
* History of Type I diabetes mellitus, insulin-dependent diabetes mellitus(IDDM)
* History of significant dermatologic cancers (melanoma, squamous)
* Known history of immunologic disorders
* Use immunosuppressive or other proscribed medications
* Use of skin products at the application site
* Significant history of allergies to soaps, lotions, emollients, ointments, creams
* History of drug or alcohol addiction within the past year
* Pregnant, lactating, breast-feeding, or intends to become pregnant during the course of the study
Remote Ischemic Conditioning for the Treatment of Resistant Hypertension

This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.

Resistant hypertension is defined as a blood pressure of 140/90 mmHg or higher despite adherence to at least three antihypertensive drugs (including one diuretic), accounting for 20% to 30% of patients with hypertension. Compared with patients with well-controlled blood pressure, the cardiovascular risk of resistant hypertension is increased by about 50%. Limb remote ischemic conditioning (LRIC) triggers endogenous protective effects through transient and repeated ischemia in the limb to protect remote tissues and organs. The mechanisms of LRIC involve the regulation of the autonomic nervous system, the release of humoral factors, improvement of vascular endothelial function, and modulation of immune/inflammatory responses, which can antagonize the pathogenesis of hypertension through multiple pathways to lead to a drop in BP theoretically. This theory has been preliminarily confirmed by several small sample-size studies in non-resistant hypertension. This study aims to explore the efficacy and safety of remote ischemia adaptation for the treatment of resistant hypertension.

Eligibility Criteria:
Inclusion Criteria:

* Aged 30\~80 years old;

  * Taking ≥ 3 antihypertensive drugs (including one diuretic) for more than 4 weeks regularly;

    * Office blood pressure ≥ 140/90mmhg, and 24 h average blood pressure ≥ 130/80 mmHg;

      * Willing to participate in the study, follow the study protocol, and provide informed consent.

Exclusion Criteria:

* Secondary hypertension;

  * eGFR\<45ml/min/1.73m2；

    * Office blood pressure ≥180/110 mmHg, and 24 h average blood pressure ≥ 170/100 mmHg；

      * Hypertensive crisis occurred within 3 months;

        * Type 1 diabetes;

          * Cardiovascular events occurred within 3 months;

            * Atrial fibrillation;

              * Presence of any severe disease that adversely affects the subject or study;

                * Patients with contraindication for remote ischemic conditioning, such as vascular injury, soft tissue injury, orthopedic injury, or arm infection;

                  * Pregnancy, lactation, or planned pregnancy;

                    * Patients not suitable for this trial considered by researchers for other reasons；

                      * Participation in another device or drug trial simultaneously.
Safety and Effectiveness of the Peripheral Balloon-Expandable Covered Stent System for Iliac Artery Stenosis/Occlusion. (SELECT)

This is a prospective, multi-center, single-arm clinical trial to evaluate the Peripheral Balloon-Expandable Covered Stent System for treating stenosis and/or occlusion in the common and external iliac arteries. The safety and effectiveness of the stent system will be compared to pre-set performance goals. All treated subjects will have follow-up visits at discharge, and at 1, 6, 12, 24, and 36 months after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 to 80 years, regardless of sex;
* Participants diagnosed with atherosclerotic disease of the common iliac or external iliac artery;
* Participants with a Rutherford classification of 2 to 4 for the target limb;
* Participants or their legal representatives must be able to understand the study's purpose, demonstrate adequate compliance with the study protocol, and sign the informed consent form.

Exclusion Criteria:

* Pregnant or planning to become pregnant, or breastfeeding women;
* Participants who have previously had a vascular graft implanted in the native iliac artery;
* Participants who have had a stroke or myocardial infarction within 3 months prior to enrollment;
* Participants with known uncorrectable bleeding disorders or severe coagulation abnormalities (PT or APTT ≥ 2 times the upper limit of normal; or platelet count \&lt; 80×10\^9/L);
* Participants with serum creatinine ≥ 221 μmol/L (2.5 mg/dL) or currently undergoing dialysis;
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal;
* Severe anemia (hemoglobin level \&lt; 60.0 g/L);
* Participants known to be allergic or intolerant to cobalt-based alloys, expanded polytetrafluoroethylene (ePTFE), aspirin, clopidogrel, heparin, rivaroxaban, paclitaxel, contrast agents, or other study materials and medications;
* Participants who have undergone vascular intervention within 30 days prior to surgery or who plan to undergo vascular intervention within 30 days following surgery;
* Participants who have received intra-arterial thrombolysis treatment in the target vessel within 14 days prior to enrollment;
* Participants with significant organ dysfunction or other severe conditions that may lead to non-compliance with the study protocol, affect data interpretation, or have a life expectancy insufficient to complete the clinical trial;
* Participants currently involved in a clinical trial of investigational drugs, biologics, or medical devices;
* Other conditions that, in the investigator's opinion, make the participant unsuitable for the clinical trial.
Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency

To assess the safety, efficacy, and pharmacokinetics of IGIV-SN in pediatric subjects with primary immunodeficiency humoral diseases (PHID)


Eligibility Criteria:
Inclusion Criteria:

* Pediatric subjects with a confirmed clinical diagnosis of a Primary Humoral Immunodeficiency Disease as defined by IUIS (International Union of Immunological Societies) and require treatment with IGIV. Documented agammaglobulinemia or hypogammaglobulinemia
* Subject is willing to comply with all requirements of protocol
* Authorization to access personal health information

Exclusion Criteria:

* Subject has secondary immunodeficiency
* Subject has a history of repeated reactions or hypersensitivity to IGIV or other injectable forms of IgG
* Subject has significant protein loss from enteropathy, nephrotic syndrome or lymphangiectasia
Multimedia Admission Orientation in NICU

The effect of a multimedia admission orientation on the parental stress, uncertainty, and knowledge of primary caregivers of high-risk infants in a neonatal intensive care unit: a quasi-randomized controlled trial study.

Neonatal Intensive Care Unit (NICU) is the place of caring for high-risk newborns whose primary caregivers would be very stressful due to unfamiliar medical equipment and environment. Furthermore, those primary caregivers of critically ill infants hospitalized in NICU may be even more distress as result of the constraint in visiting time and measures of insolation. Most studies have indicated that those primary caregivers of infants in NICU can experience a high level of parental stress particularly during the initial phase of admission. The literature has reported that during the admission the infant's conditions are prone to be unstable to an extent that can threaten his or her life which can result in the feeling of helplessness, uncertainty, low self-esteem and loss of control in those parents.

The study aims to use a pre- and post-test quasi-randomized controlled trail to examine the effect of Multimedia Orientation Animation of NICU Admission for parents of critically ill infants. The video contain an introduction of common diseases seen in infants in NICU such as respiratory distress and the common medical equipment used and NICU environment. The major purpose of the educational video is to help the primary caregivers understand important information about the newborn's admission to the NICU. The data collection site of the study is one of the NICU from the north medical center in Taiwan. The subjects are grouped by time intervals, and divided into control and experimental groups, and that survey will be collected first with control group who will be provided with regular nursing care in term of admission orientation, and the experiment group is approached after the cessation of data collection from control group, which Multimedia Admission Orientation are offered to the experiment group. The measurements of the study include the caregivers' parental stress, the level of uncertainty and knowledge of admission after being treated by our intervention. The IRB of this study (IRB no.CGH-P110036) has been granted by Cathay General Hospital in Taipei, R.O.C.

Eligibility Criteria:
Inclusion Criteria of the Primary Caregiver

* 1. Able to listen, speak, write and read Chinese, report of no psychological problems, and agree to give consent and fill out questionnaires of the study.
* 3. The potential caregiver whose infant born within one month and needs to be admitted to the intensive care unit for the first time due to an acute and severe illness
* 4. For those whose infant needs to use the ventilator in admission.

Exclusion Criteria:

* 1.Have a history of mental disorders including depression, cognitive impairment, addiction to smoking or drinking.
* 2. The primary caregiver who is the care assistant/carer/nanny of the infant who admitted to the NICU.
* 3. For those potential caregiver whose infant has congenital abnormality identified by the physician.
Trial of Cardiac Magnetic Resonance Imaging (MRI) Versus Cardiac Catheterization Prior to Glenn Operation

This study is a prospective, randomized study of patients with single ventricle heart disease who are to undergo superior cavo-pulmonary anastomosis, or "Glenn" operation. Such patients have historically undergone cardiac catheterization to ensure suitability for the procedure. Cardiac magnetic resonance imaging (cardiac MRI) is a newer technology that provides excellent anatomic and functional imaging of the heart. This study is designed to demonstrate our hypothesis that cardiac magnetic resonance imaging will provide comparable information to catheterization, with less side effects.

This is a prospective, randomized study of patients with single ventricle congenital heart disease presenting for superior cavo-pulmonary anastomosis, or "Glenn" operation. Such patients in the past have routinely undergone pre-operative invasive cardiac catheterization to assess anatomic and hemodynamic suitability for this procedure. Recent retrospective reviews, including our own (J Thorac Cardiovasc Surg 2003: July;126(1):272-81) have suggested that such catheterization may not benefit many patients, and that non-invasive assessment may allow adequate evaluation while avoiding many (typically minor) complications seen with cardiac catheterization in this high risk group of infants. Cardiac MRI is a non-invasive imaging modality that can deliver superior anatomic information (such as vascular and intracardiac anatomy) as well as functional data (ventricular volumes and ejection fraction), and may be a safe alternative to catheterization in such patients. In this study, patients undergo screening echocardiogram prior to enrollment in the study to assess degree of risk for the operation (such as pulmonary vein obstruction, a clear risk factor for poor outcome) or for demonstrated need for catheterization intervention (such as aortic arch obstruction requiring balloon dilation); patients with low risk echocardiograms whose parents grant informed consent for the study are then randomized in a prospective fashion to cardiac MRI or cardiac catheterization. The findings of each study are then reviewed by the subject's cardiologist and cardiac surgeon; patients in whom further pre-operative information may cross over to another study if deemed necessary (such as catheterization in patients in whom an unsuspected finding is noted, or cardiac MRI in patients in whom further functional data may be desired). Patients are followed for details of the hospital stay (including hospital length of stay, complications, hospital charges) for the pre-operative testing, as well as operative and post-operative outcomes (new/missed diagnoses, hospital stay, operative and post-operative complications, achievement of a clinical definition of a "good" outcome from the Glenn operation).

Eligibility Criteria:
Inclusion Criteria:

* Single ventricle heart disease patients presenting for Glenn operation

Exclusion Criteria:

* Aortic arch obstruction
* Pulmonary vein stenoses
* Severe ventricular dysfunction
* Pulmonary hypertension
Social Media, Smartphone Use and Self-harm in Young People

Self-harm is when somebody hurts their body as a way of coping with difficult feelings. Self-harm is becoming increasingly common in young people, particularly in adolescent females. The rise in self-harm has been linked to increasing use of social media and internet technology among young people. However, the evidence is limited to associations with poorer mental health outcomes rather than identifying particular aspects of using these technologies that can negatively impact on mental health.

This study aims to investigate how the use of social media and a smartphone may increase the risk of self-harm in young people by exploring changes in usage in the period leading up to an episode of self-harm. The information from this study will allow us to understand whether there are certain behaviours that are more likely to occur before an episode of self-harm. This will inform new strategies to identify and provide support to vulnerable young people. For example, linking young people with crisis support or empowering young people to make changes, manage their own risks and build resilience.

This study will recruit young people aged 13-25 years old who have accessed mental health services provided by an NHS Trust in South-East London. Young people will be invited to provide information on their mental health and social media and smartphone use over a period of six months.


Eligibility Criteria:
Inclusion criteria

* Identified via SLaM's C4C patient research participation register or referral to the study team by their clinician.
* Aged 13-25 years old at the time of study approach.
* Accessed mental health services at SLaM in the last 12 months.
* Has capacity to consent (and an adult with parental responsibility for young people aged 13-15 years old). Mental capacity will be assumed unless evidence from a clinician or during contact with the study team suggests otherwise.

Exclusion criteria

* Unable to complete the questionnaires via the study software application or online survey platform.
* Admitted to an inpatient psychiatric ward, sectioned under the Mental Health Act or in prison at the time of approach.
* Clinician advises it is not appropriate to approach.
Retrobulbar Methylprednisolone as Adjunctive Treatment in Optic Neuritis Trial

A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.

A double-blind prospective randomized clinical trial of treatment for optic neuritis comparing visual outcome of patients treated by standard therapy (intravenous methylprednisolone) + placebo injection and standard therapy + retrobulbar methylprednisolone.

Enrollment: 50. Randomized groups (2)

1. Standard treatment + placebo
2. Standard treatment + intervention Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned

Eligibility Criteria:
Inclusion Criteria:

* Both genres
* Age between 18 and 85 years old.
* Optic neuritis diagnosis ( relative afferent pupillary defect, acquired dyschromatopsia, low vision, prechiasmatic campimetric defect)
* 1 month after symptoms started
* If is a bilateral simultaneous optic neuritis the eye with the worst vision will be included.
* if is a bilateral sequential optic neuritis the eye with lees 1 month evolution will be included.

Exclusion Criteria:

* Visual field better than 20/60 at the beginning of the study.
* History of optic neuritis in the eye under study.
* History of additional ophthalmological or neurological pathology that has caused visual loss in the eye under study.
* History of previous treatment with intravenous methylprednisolone since the onset of symptoms.
* History of high myopia.