cyrilzakka/clinical-trials huggingface dataset:
Zinc Supplementation Prior to Botox Injections for Spasmodic Dysphonia

One initial study has shown that Botulinum Toxin (BT) in combination with zinc supplementation may increase the duration of effects BT treatment. This initial study was in the context of facial aesthetics. The purpose of the present study is to determine the effect, if any, of oral zinc supplementation prior to BT in the treatment of spasmodic dysphonia. If positive effects will be observed, this would help reduce the burden of disease for these patients.

Botulinum toxin (BT) injections are commonly used to treat various cosmetic, muscular, anesthetic, and neurologic pathologies. In 2012, one study suggested that a combination of zinc and phytase supplementation could increase the duration and degree of effects of botulinum neurotoxin type A (BoNTA). However, this study was met with scientific skepticism due to concerns of financial conflicts of interest, unmasking the study too early, and ambiguity of the dosage of zinc used. In 2021, a new study with 25 patients receiving BoNTA injections for the treatment of excessive gingival display (EGD), showed that zinc supplementation prolonged the effect of BoNTA with statistical significance. There has been no further studies or commentary since these latest results were published. The purpose of this study is to test if the effect of zinc supplementation on BoNTA can be replicated and also translated to a different disease process that is also treated with BT-spasmodic dysphonia (SD). If positive effects are discovered, this would strengthen the preliminary results of the 2021 study, encourage future larger studies on the same hypothesis, and, ultimately, could lead to reducing the burden of disease for patients with SD and any other condition that is treated with BT injections.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients
* 18 years old and above
* Current diagnosis of ADductor spasmodic dysphonia
* Has had Botox injection treatments for SD \> 6 months

Exclusion Criteria:

* Pregnant
* Diagnosis of ABductor spasmodic dysphonia
* Patients taking \> 30 mg zinc supplementation daily prior to study beginning
HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma

Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.

This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.

Eligibility Criteria:
Inclusion Criteria:

1. primary infiltrative HCC according to MRI or CT imaging characteristics.
2. Child-Pugh class A or B, and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
3. Lenvatinib as initial treatment.
4. patients received HAIC and PD-1 inhibitor in HAIC+Len+PD-1 group, patients received Lenvatinib alone in Len group.
5. no history of other malignancies.
6. no tumor thrombus in the atrium or vena cava.

Exclusion Criteria:

1. HCC with tumor capsule.
2. under 18 years or over 75 years.
3. TACE as initial treatment.
4. sorafenib or other systemic therapy with or without PD-1 inhibitor following HAIC.
5. incomplete tumor imaging data.
6. lost to follow-up after treatment within three months.
Liver Regional Oxygen Saturation in Preterm Patent Ductus Arteriosus

This study evaluates the usefulness of liver perfusion and oxygenation status using regional oxygen saturation (RSO2) values obtained via near-infrared spectroscopy in assessing the hemodynamical significance of patent ductus arteriosus in preterm infants.

The usefulness of cerebral and renal regional oxygen saturation (RSO2) values for assessing hemodynamically significant patent ductus arteriosus (hsPDA) has been described previously. Meanwhile, autoregulation of the splanchnic organs' perfusion is less developed compared to the cerebral and renal system, which makes the splanchnic bed more prone to perfusion decrease and ischemia in cases of volume depletion or poor circulation. If RSO2 is measure in the liver, the solid organ reflecting the splanchnic bed perfusion status, hsPDA may be more readily identified than when only cerebral and/or renal RSO2 is monitored.

This study aims to evaluate the usefulness of liver RSO2 measurement in assessing the hemodynamical significance of patent ductus arteriosus in preterm infants, in comparison to cerebral and renal RSO2.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age at birth less than 32 weeks
* Birthweight less than 1,500 grams

Exclusion Criteria:

* Major congenital anomaly
* chromosomal / genetic anomaly
Evaluate Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD

The purpose of this study is to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD.

In order to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children and adolescents with ADHD, subjects who participated in the previous OP-2PN012-301 study will be invited to join this extension study for 24-month follow-up. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose.

Eligibility Criteria:
Main Inclusion Criteria:

1. Subjects previously enrolled in OP-2PN012-301 study and completed 4-week study treatment
2. Both subjects and parents/guardians have provided their signed and dated informed consent form for the study

Main Exclusion Criteria:

1. Subjects who experienced unmanageable adverse events (AEs) after receiving ORADUR®-Methylphenidate
2. Subjects are taking a concomitant medication (ex: Monoamine Oxidase Inhibitor (MAOI) or other ADHD treatments) that is likely to interfere with safe administration of methylphenidate within 14 day prior to the study treatment initiation
3. Subjects are joining other clinical studies and receiving any other investigational medical products within 14 days prior to the study treatment initiation.
4. By the investigators' discretion, subjects with serious or unstable medical illness that will interfere with the evaluations of study efficacy and safety
5. By the investigators' discretion, subjects cannot understand or follow the instructions given in the study
6. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Veterans Living With HIV/AIDS: A Pilot Study Examining Risk Factors Associated With Self-Directed Violence

The purpose of this project is to gather pilot data related to risk factors associated with suicide in Veterans with Human Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency Syndrome (AIDS) and to develop an educational and interventional tool and instructional guide that can be utilized by local and national providers to increase understanding regarding suicide risk assessment. There are no hypotheses associated with this qualitative pilot study.

To achieve these goals, a semi-structured interview will be conducted to gather this qualitative information. Specifically, this study aims to gather the following information from Veterans with HIV/AIDS: a) information regarding disease acquisition; b) psychosocial stressors; c) social supports; d) protective factors; and e) previous suicidal ideation and behaviors. Further, additional exploratory questions will be asked regarding proposed modifications to the Suicide Risk Assessment Guide Pocket Card, an existing VA tool, so that it can be modified for use by local and national HIV/AIDS providers.

Eligibility Criteria:
Inclusion Criteria:

* Between ages 18 to 90
* Have a diagnosis of HIV/AIDS
* Currently receiving HIV/AIDS treatment
* Currently receiving or eligible to receive physical and/or mental health care through the VA Eastern Colorado Health Care System

Exclusion Criteria:

* Psychosis at time of interview as determined by observation and/or interview.
* Intoxication via alcohol or other illicit drugs at time of assessment as determined by observation and/or interview.
Evaluation of the Effects of the New Program for Cognitive Enhancement and Improvement in the Elderly

The purpose of this study is to investigate the effect of cognitive rehabilitation program on the improvement of cognitive functions in normal elderly subjects.

The cognitive rehabilitation program was developed to improve cognitive functions of the elderly or patients with cognitive impairments. The study will enroll 40 healthy subjects with a normal cognitive function between 55 and 85 years of age. Forty subjects will be randomly assigned into two groups. Subjects in the intervention group will receive four weeks of cognitive rehabilitation training, three times per week and 30 minutes per day. The control group will not receive any intervention. The investigator will measure their cognitive and brain functions three times at pre-intervention, post-intervention and four weeks after intervention to assess the effectiveness of the cognitive training program.

Eligibility Criteria:
Inclusion Criteria:

* Normal Healthy individuals
* No cognitive impairments
* No history of neurologic diseases

Exclusion Criteria:

* Severe cognitive problems
* Other problems disturbing cognitive tests
A Study of [¹⁴C]-LY3484356 in Healthy Female Participants

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts. It will involve a single dose of 14C radiolabeled LY3484356. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Female participants of nonchildbearing potential. This includes females who are not pregnant, non-lactating and either: Infertile due to surgical sterilization or alternate medical cause/congenital or postmenopausal.
* Body mass index (BMI) within the range of 18.0 to 35.0 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorders
* Have evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
* Have known allergies to LY3484356, related compounds or any components of the formulation as appropriate, or history of significant atopy
Scrambler Therapy in Treating Chronic Pain in Patients With Rash From Varicella Zoster Virus Infection

This pilot clinical trial studies how well scrambler therapy works treating chronic pain in patients with rash from varicella zoster virus infection. Scrambler therapy may help relieve pain from a rash caused by varicella zoster virus infection

PRIMARY OBJECTIVES:

I. To explore whether we can decrease post-herpetic neuralgia (PHN) pain with scrambler therapy.

OUTLINE: Patients undergo scrambler therapy for approximately 30 minutes. Treatment continues for 10 days in the absence of pain progression or unacceptable toxicity. After the completion of study treatment, patients are followed up for 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Pain of \>= 1 month (30 days) duration attributed to zoster, for which the patient wants intervention
* Pain at least a four out of ten problem during the prior week, on a 0-10 scale where zero was no problem and ten was the worst possible problem
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2
* Life expectancy \>= 3 months (90 days)
* Ability to complete questionnaire(s) by themselves or with assistance
* Provide informed written consent

Exclusion Criteria:

* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown
* Pregnant women
* Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
* Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices)
* Patients with a history of myocardial infarction or ischemic heart disease within the past six months
* Patients with history of epilepsy, brain damage, use of anti-convulsants for seizure prevention, symptomatic brain metastases; Note: anti-convulsant use is allowed for neuropathy and heart failure (HF) if on a stable dose
* Other identified causes of pain in the area that was affected by herpes zoster
* Skin conditions such as open sores that would prevent proper application of the electrodes
* Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
* Prior treatment with Calmare MC-5A therapy
* Patient initiation of a new analgesic treatment within 7 days prior to initiation of protocol treatment
Daytime Corneal Swelling During Wear of Narafilcon B Lenses

The purpose of this research is to measure daytime open-eye response to wearing of narafilcon B lenses.


Eligibility Criteria:
Inclusion Criteria:

* Be of legal age (i.e. ≥ 18 years).
* Be mentally competent, willing and able to sign a written informed consent form.
* Have contact lens distance sphere requirement in the range -1.00D to -6.00D.
* Have spectacle astigmatism \<1.25D in each eye.
* Currently wear soft contact lenses (for at least 6 months prior to the trial) with documentation of current prescription.
* Have normal eyes with no evidence of abnormality or disease. For the purpose of this study a normal eye is defined as one having: i) no evidence of lid abnormality or infection; ii) no conjunctival abnormality or infection; iii) no clinically significant slit lamp findings (i.e, edema, staining, scarring, vascularization, infiltrates or abnormal opacities); iv) no other active ocular disease.

Exclusion Criteria:

* Required concurrent ocular medication.
* Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
* Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
* Abnormal lacrimal secretions.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Keratoconus or other corneal irregularity.
* Pregnancy, lactating or planning a pregnancy at the time of enrollment.
* Participation in any concurrent clinical trial.
Prevention in Volleyball Players

The objective of this study is to assess the interest and the efficiency of a warm-up prevention program on the prevalence of shoulder injuries in amateur volleyball players.

Around ten teams will be included in the study. They will be divided into two groups (blind): an intervention group and a control group.

A warm-up prevention program will implemented in the teams of intervention group. This program will have to be followed twice a week, at the beginning of the training session.

In both groups, shoulder injuries will be registered each month by an online questionnaire.

Around ten teams will be recruted among the clubs in the Province of Liege. They will be divided into two groups (blind): an intervention group and a control group.

Each month, both groups will be asked to fill in a form with the potential injuries they experienced during the past month.

* Intervention group :

All the teams included in the intervention group will be asked to follow a warm-up prevention program (about 15 minutes) at least twice a week, at the beginning of the training session.

At the beginning of the season, one experimenter will go to the different clubs in order to present the program, to explain the exercises and to correct the players while doint the exercises.

During the season, the same experimenter will go to the clubs at regular intervals to make sure that the players are well doing the program and to assess the compliance.

- Control group :

The objective of the control group is to estimate the prevalence of shoulder injuries in a group without any prevention implementation. The players of this group will jus have to answer the monthly questionnaire about the potential injuries they experienced during the previous month.

Eligibility Criteria:
Inclusion Criteria:

* volleyball players in Provincial level (P1-P2)
* practicing volleyball at least 4 hours in a week
* no "prevention routines"

Exclusion Criteria:

* having a prevention program
Role of EndoFLIP in the Diagnostic Paradigm of Esophagogastric Junction Outflow Obstruction

The aim of this project is to identify if EndoFLIP can categorize and change the diagnosis in patients with EGJOO and if categorization with EndoFLIP can predict the response to treatment with botulinum toxin at 12 weeks post procedure. Our hypothesis is that there will be greater symptom resolution in the treatment versus control in the abnormal DI category. In addition, we hypothesize there will be less symptom resolution in the control group with an abnormal DI as compared to those with a normal DI who also receive no treatment.

Esophagogastric Outflow Obstruction (EGJOO) is a newer diagnosis in which some patients' symptoms resolve spontaneously or with conservative treatment, while others require treatment with botulinum toxin injected into the lower esophageal sphincter. Currently, there is no way to distinguish these two groups of patients upon diagnosis. EndoFLIP (endolumenal functional lumen imaging probe) is a new technology that can measure the distensibility index (DI) of the lower esophageal sphincter. Data has suggested that normal and abnormal DI measurements can categorize these patients and guide treatment course (1). Our study looks to confirm this finding.

1. Elsbernd et al. Clinical characteristics and treatment response of esophagogastric junction outflow obstruction. Gastroenterology 2019;156(6):S-1017.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with esophagogastric junction outflow obstruction by high resolution manometry

Exclusion Criteria:

* previous upper gastrointestinal surgery
* significant medical co-morbidities
* eosinophilic esophagitis
* severe reflux esophagitis (LA-classification C or D)
* large hiatal hernia
* patients experiencing significant weight loss suspicious for malignancy
* Vulnerable populations such as cognitively or decisionally impaired individuals, children, pregnant women, prisoners, and students or employees of the University of Kansas Health System or Medical Center
HFNC for Induction During Bariatric Surgery Patients.

This study aims to compared the effects of high flow nasal during the induction and during the weaning of anesthesia on intraoperative and postoperative oxygenation and postoperative atelectasis in obese patients undergoing bariatric surgery versus the standard of care, which consists in supplemental oxygen with face mask (Venturi mask).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index \> 35 Kg/m2
* Bariatric surgery
* Informed consent signed

Exclusion Criteria:

* age \<18yr or \>80yr
* pregnancy or breast-feeding status
* patients with previous known respiratory disease
* hemodynamic instability at entry (need of vasopressors or ionotropes at entry or a ventricular assist device
Regional Anesthesia for Major Surgery of the Foot. Levobupivacaïne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Through médiofémorale

Ropivacaine 0.5% and 0.5% in levobupivacaïne are used in regional anesthesia for major surgery of the foot. The literature does not highlight a significant difference in terms of onset of action between these two molecules to block the sciatic nerve \[4\]. Our hypothesis is that this lack of difference is due to the use of a neurostimulator for locating the injection site (indiscriminate nature of the anatomical approach to the sciatic nerve). Indeed, the sensitivity of neurostimulation is low compared with ultrasound \[58\] and ultrasound, for accurate visualization of the deposit of the local anesthetic around the nerve to improve the quality of the block and reduce the onset of action of local anesthetic \[46, 47\].

The investigators propose to make a comparative trial between levobupivacaïne 0.5% ropivacaine and 0.5% under the control of the ultrasound as part of a sciatic nerve block. The use of ultrasound will reduce the variability of results because the changes would be linked exclusively to the local anesthetic. The investigators test the hypothesis that levobupivacaïne gives better results in terms of onset of action than ropivacaine.


Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral major surgery of the foot: hallux valgus (not ambulatory), claw toes, fusion-Astragalo calcaneum, complex syntheses of tarsus-aged over 18 years .
* Male and female
* ASA 1 or 2
* Insured Social
* Informed Consent

Exclusion Criteria:

* Diabetes
* Intoxication-alcoholic chronic
* Allergy to local anesthetics
* Hemostasis disorders
* Hepatic failure
* Chronic pain syndrome