cyrilzakka/clinical-trials huggingface dataset:
Abdominal and Lower Extremity Compression During Tilt Table Testing in Adolescent POTS Patients

Postural orthostatic tachycardia syndrome (POTS) is a common cause of orthostatic intolerance in adolescents and adults. Compression stockings are commonly recommended as a treatment modality for POTS, but the effects of abdominal and lower extremity compression during tilt table testing have not been measured in adolescent patients. The aims of our study are to compare heart-rate changes and symptom onset during tilt table testing (a) with and without abdomen/lower extremity compression and (b) with abdominal compression only versus lower extremity compression only. During phase 1, 20 adolescents with POTS will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with full compression (trial #2), and a third study without compression up to 10 minutes (trial #3). Compression will be performed using the non-inflatable Zoex anti-shock garment. During study phase 2, an additional 20 adolescent POTS patients will undergo up to 10 minutes of tilt without compression (trial #1), a repeat study of up to 10 minutes with abdominal compression only \[n=10\] or lower extremity compression only \[n=10\] (trial #2), and a third study repeated without compression up to 10 minutes (trial #3). To limit compression to the abdomen only, we will use the Zoex garment strap numbers 4 and 5 (thigh and abdomen) without straps 1-3 (lower extremities). For lower extremity-only compression, we will use Zoex garment straps 1-4 (lower extremity and thigh) without strap 5. Data collected will include mean and peak heart rates and timing of symptoms with each trial. A paired-samples t-test will be used to compare mean heart rates between trials for each study phase. Hazard analyses will be used to assess time-based endpoints.


Eligibility Criteria:
Inclusion Criteria:

1. Age 12-19 years
2. POTS diagnosis
3. English speaking -

Exclusion Criteria:

1. Somatic, cognitive, or psychiatric disorder that could prevent safe tilt table testing
2. Medications that cannot be stopped/held safely for the procedure, but can cause or exacerbate orthostatic intolerance -
Neurological Dry Eye Study Stimulating Both Lacrimal and Vagus Nerves

This is a study on neurological dry eye disease, focusing on a patented over-the-counter supplement supporting tear production neurologically, including the lacrimal and vagus nerves.

Chronic inflammation is implicated in the majority of chronic dry eyes. The parasympathetic nervous system is responsible for both basal tear secretion (the aqueous layer) by the lacrimal functional unit, and is responsible for controlling many aspects of chronic inflammation via the vagus nerve.

This study will document its effects on dry eyes, in addition to other symptoms/signs of low parasympathetic nervous system functioning using an over-the-counter supplement.

Eligibility Criteria:
Inclusion Criteria:

* Must have dry eye (OSDI score 30 and above)
* Tear break up time of less than or equal to 7 seconds
* Must be able to come for baseline tests and again at 4 weeks

Exclusion Criteria:

* Demodex
* Corneal scarring
* must not take Physostigmine (glaucoma), Pyridostigmine (Mestinon), Neostigmine (for Myasthenia Gravis); Aricept (for Alzheimer's), or ingredients to NeuroTears
* No known allergies to ingredients in NeuroTears
Communities Helping the Hearing of Infants by Reaching Parents

Hearing loss is the most common sensory congenital disorder and this condition is diagnosable and treatable. Children that are born with hearing loss have to undergo several hearing tests to diagnose the condition and many families are delayed in receiving this testing or never obtain the needed testing. This research employs a new method for helping children with hearing loss receive timely care by using a patient navigator, who is someone who teaches and provides emotional/social support for the families of these children.

The hypothesis of this study is that a patient navigator will hasten the timing of pediatric audiological testing, improve compliance with scheduled appointments, and expand parental knowledge of pediatric hearing loss.

For Specific Arm 1:

The investigators will (1) use a stepped-wedge trial design to deliver patient navigation (PN) sequentially in 10 state-funded Kentucky Commission for Children with Special Healthcare Needs (CCSHCN) (also referred to as the Office for Children with Special Healthcare needs or OCSHCN) clinics randomized to cross from usual care to PN in steps of 6-month intervals over the project period. Prior to initiation of PN at each clinic, the control condition will be the standard of care. The overall effectiveness of PN will be tested by comparing non-adherence rates during the PN condition to those during the standard of care condition. Simultaneously, the investigators will (2) assess preliminary implementation outcomes (i.e., acceptability, adoption, recruitment/retention, and fidelity) as well as multilevel factors influencing implementation of PN in each clinic.

For Specific Arm 2:

Patient navigators will not be used for all subjects at participating clinics.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for parent-infant dyads:

1. Infant failed a hearing screening in one or both ears before postnatal hospital discharge
2. Infant was referred for follow-up diagnostic testing at one of the 10 participating CCSHCN clinics.
3. Parent able to speak either English or another language using Cyracom phone interpreting services.

Exclusion Criteria:

1. Children and parents live outside Kentucky or who will be moving out of Kentucky within the first three months of life.
To Evaluate Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Severe Renal Impairment Compared to Participants With Normal Renal Function

The primary purpose is to assess the effect of renal impairment on the PK of tavapadon following administration of a single oral dose in participants with severe renal impairment relative to age, body weight, and sex-matched participants with normal renal function.


Eligibility Criteria:
Key Inclusion Criteria:

1. Body mass index of ≥18.0 to 40.0 kilograms per meter square (kg/m\^2), inclusive, and a total body weight \>50 kilograms (kg) \[(110 pounds (lbs)\].
2. Age that is within ±10 years of the median age for the severe renal impairment cohort. Bodyweight that is within ±15 kg of the median bodyweight for the severe renal impairment cohort.
3. Severe renal function: estimated glomerular filtration rate (eGFR) \<30 mL/min (not requiring dialysis) determined using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
4. Stable disease, defined as no clinically significant changes in disease status as documented by the most recent eGFR assessment (within at least 3 months before Screening).
5. Stable concomitant medications for the management of individual participants medical history.

Key Exclusion Criteria:

1. Serious risk of suicide in the opinion of the investigator.
2. History of substance or alcohol use disorder (excluding nicotine or caffeine) within 12 months prior to signing the informed consent form (ICF).
3. Receipt of severe acute respiratory syndrome coronavirus 2(SARS-CoV2) vaccine or booster within 7 days of planned dosing.
4. Have recently been diagnosed with symptomatic Coronavirus Disease 2019 (COVID-19) or test positive for COVID-19 within 30 days prior to signing the ICF.
5. Positive drug screen including tetrahydrocannabinol (THC).
6. Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at Screening.
7. Positive drug screen including THC (except with a vail prescription other than medical marijuana).
8. Participants who have received an organ transplant or are currently waiting for an organ transplant and are listed on the national transplant list.
9. Participants who require dialysis.
10. Participant with nephrotic syndrome.
11. Abnormal hemoglobin.
12. Abnormal blood pressure measurement or heart rate at Screening or Check-in.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The Chinese Hypertrophic Cardiomyopathy Study(CHCS)

Hypertrophic cardiomyopathy (HCM) is one of the most common inherited cardiac diseases, with a prevalence of ∼0.2%. Sudden cardiac death (SCD), heart failure and stroke are the major poor outcomes of HCM. Although about half of the patients were found to be caused by mutations mainly located in genes encoding sarcomere proteins, the causes in a significant proportion of patients with HCM are still unknown. Even in the patients with sarcomere mutations, the molecular pathways that eventually lead to cardiac hypertrophy are remained to be revealed. Furthermore, HCM presents with significant heterogeneity. SCD risk stratification and prevention by ICD are necessary. However, the strategy of SCD risk stratification recommended by the 2011 ACCF/AHA and 2014 ESC guidelines were based mainly on the evidence derived from American and European countries. The accuracy of these guidelines in Chines patients with HCM was not evaluated yet.

In the present study, patients with HCM are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hr Holter, echocardiography, MRI and other examinations if necessary. The specimens retained include blood for all patients and myocardium for patients receive surgery of myocardial myectomy. Multi-omics screening, including genomics, epigenomics, transcriptomics, proteomics, metabolomics, will be performed to identified novel disease genes, signal pathway or processes, genetic risk factors and potential therapy targets of HCM. Furthermore, besides examining the accuracy of SCD risk prediction of the 2011 ACCF/AHA and 2014 ESC guidelines, we will identify novel risk factors associated with the clinical outcomes and construct predictive models suitable for Chinese patients with HCM.

Eligibility Criteria:
Inclusion criteria: Patients with HCM diagnosed by observation of unexplained maximal left ventricle wall thickness ≥15 mm on echocardiography and/or cardiac magnetic resonance imaging or or ≥13 mm for individuals with family history of HCM.

Exclusion criteria: Individuals with other cardiac or systemic diseases capable of producing that magnitude of cardiac hypertrophy.
Open and Comparative Study to Measure Tolerability and Efficacy of Taro Elixir

To measure the efficacy of Taro Elixir compare with Oxytetracycline in the treatment of boils or acne.


Eligibility Criteria:
Inclusion Criteria:

* Both of gender patient, older than 14 years;
* Patient with boils or acne vulgaris II or III degree;
* The score must be at least than 4, for 2 or more question of VAS (visual analog scale);
* Patient that have been used an effective contraceptive method in the last 3 months, including sexual abstinence and that keep using that method during the study until a month after;
* Patient that have been accepted to participate of the study and signed the Informed Consent or in case of younger than 18 years, the responsable must read and sign the Informed Consent.
* Patient that have been accepted to meet all the visits stipulated at the protocol, whenever the investigator request in .

Exclusion Criteria:

* Patient of female gender that has been pregnant, breastfeeding or that has not been use a safe contraceptive method (oral contraceptives or barrier methods). Sexual abstinence will be accept if the investigator think that it is relevant.
* Patient that has been use antiandrogens (cyproterone, finasteride, flutamide, tamoxifen, spironolactone);
* Patient with acne I or IV degree;
* Patient that has been receive some treatment for acne as antibiotics, corticosteroid or any medicine that can maybe interfere in the study results: a month for systemic treatment or two weeks for topic treatment, before inclusion or during the study;
* Patient that received treatment with oral retinoids within 6 months before the inclusion and during the study;
* Patient that had a known decompensated diabetes history;
* Patient with immunodeficiency and liver, renal, cardiac, digestive, metabolic, endocrinological, hematological, neurological or psychiatric disorders, evaluated through anamnesis by the investigator, tha can maybe interfere on the study evaluation. Even the patient with facial dermatoses such as psoriasis, acne rosacea, allergic dermatitis, skin infections caused by fungi, bacteria and viruses;
* Patient with alcoholism history, illicit drugs use, psychological ou emotional problems that can maybe void the Informed Consent or limit the capacity of the patient follow the protocol requirements ;
* Patient hypersensitive to any one of the medicine components;
* Patient that have been used any drug under search, 3 months before the visit number one.
Study on the Safety for the Newborn of the Use of Biologics During Pregnancy by Mothers Affected by Autoimmune Diseases

The goal of the study is to evaluate the effects on the offspring and therefore the safety of using biologic agents during pregnancy and their eventual consequences on children. The effects considered are divided into peri-partum and more long-term effects. Demonstration of safety in children born from mothers who received biologics during pregnancy will pave the way of their use in other women affected by autoimmune diseases unresponsive to standard treatment.

Biologic agents are a group of genetically engineered drugs that target the immune system and have gained a lot of popularity in recent years. They act by interfering with cytokine function or production, inhibiting the "second signal" required for T-cell activation or by depleting B-cells. They are used for the treatment of a wide variety of diseases including Rheumatoid Arthritis, Psoriatic Arthritis, Systemic Lupus Erythematosus (SLE), some types of vasculitis and many more. Many of these pathologies occur in young women during child-bearing years and so it is important for these drugs to not only be safe to use for the patient but also during pregnancy for fetus and child. Many studies are conducted on their safety for the patients but few studies are present on the safety of use during pregnancy. There are even fewer studies that follow up for long term effects on the children outside of the perinatal period.

The goal of the study is to evaluate the effects on the offspring and therefore the safety of using biologic agents during pregnancy and their eventual consequences on children. The effects considered are divided into peri-partum and more long-term effects. Demonstration of safety in children born from mothers who received biologics during pregnancy will pave the way of their use in other women affected by autoimmune diseases unresponsive to standard treatment.

Eligibility Criteria:
Inclusion Criteria:

* children born from mothers treated with biologic agents

Exclusion Criteria:

-
First Study in Humans With GSK206136

This is the first study in humans with GSK206136 to evaluate what effects: good or bad, the drug has on human health (safety and tolerability) and the amount of drug which gets into the bloodstream and is eliminated from the body (pharmacokinetics). Also the study aims to investigate the penetration of the drug in the human brain by using PET (Positron Emission Tomography) imaging technology


Eligibility Criteria:
Inclusion Criteria:

* Healthy males aged 18-45 years, limited to 25-40 years of age for PET section

Exclusion Criteria:

* The subject has a positive: drug/alcohol, Hepatitis, HIV screen..
* The subject has a history of psychiatric illness suicidal attempts or behaviour.
* Abuse of alcohol.
* Clinically significant laboratory, ECG abnormality;
* The subject has recently received an investigational.
* Use of prescription or non-prescription drugs,
* History or presence of allergy to the study drug or drugs of this class,
* Donation of more than 500 mL blood within the 90 days before dosing.
* An unwillingness of male subjects to comply with contraceptive requirements
* Average daily caffeine intake exceeding Protocol requirements.
To Explore the Effectiveness and Feasibility of HERADERM Hydrogel Wound Dressing on Caesarean Section Surgical Site

The wound of cesarean section involves multiple layers of tissue and often cause significant postoperative pain. The epidermal wound typically heals within 1 to 2 weeks after surgery. In current clinical practice, advanced wound dressings are commonly used for postoperative wound care. The theory of moist wound healing was first proposed by Winter in 1962, advocating that maintaining a moist environment around the wound can accelerate the healing process.

HERADERM Hydrogel Wound Dressing (Sterile) was approved by the Taiwan FDA in 1999. Although HERADERM Hydrogel Wound Dressing (Sterile) are frequently used clinically for post-cesarean section wound care, there have been no comprehensive reports evaluating the effectiveness and clinical application of the dressings to date. The purpose of this study is to explore the effectiveness and feasibility of HERADERM Hydrogel Wound Dressing on caesarean section surgical site and to provide user experience and clinical data for reference by patients and clinical personnel.

In this observational, prospective, single-arm study. We aimed to explore the effectiveness and feasibility of HERADERM Hydrogel Wound Dressing (Sterile) on caesarean section surgical site. Written informed consent are obtained before subjects participate in the study. Eligible subjects will be taken initial wound photos and use experimental dressings for postoperative wound care after closure of caesarean section wound site. To evaluate the clinical applicability of the experimental dressings, wound healing assessments will be conducted by independent study nurse during the postoperative period, hospitalization, and follow-up visits. Information of pain intensity experienced by subjects during dressing removal will be collected. Additionally, satisfaction surveys based on subjects' experiences of wearing and changing the experimental dressings will also be collected during the hospitalization and follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18, scheduling for a transverse incision cesarean section, and using HERADERM Hydrogel Wound Dressing (Sterile) for wound care at the end of the surgery.
2. Gestational age over 37 weeks on the day of the cesarean section.
3. Body mass index (BMI) less than 35 kg/m² on the day of the cesarean section.
4. Subjects must be able to comply with follow-up wound care visits and subsequent monitoring.

Exclusion Criteria:

1. Subjects unwilling to sign the consent form or with poor compliance.
2. Currently suffering from severe immune-related skin diseases, such as severe urticaria, generalized eczema, pemphigus, lupus erythematosus, etc.
3. Using medications that affect wound healing (e.g., glucocorticoids, anticoagulants and immunosuppressive drugs).
4. Subjects were deemed unsuitable for participation by investigator, such as uncontrolled infection and conditions that interfere with wound healing.
Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles

To evaluate the wrinkle-reducing effects of 3.25-MHz radiofrequency (RF) energy delivered in 4 weekly applications to human periorbital skin area by grating pre- and 90-days post treatment photographs on the Fitzpatrick Wrinkle Severity Scale (FWSS) by three blinded evaluators.


Eligibility Criteria:
Inclusion Criteria:

* 35-60 years old
* periorbital wrinkles

Exclusion Criteria:
Oral Versus Intravenous Antibiotics for the Treatment of Pleural Space Infection: a Randomized Controlled Pilot Trial

We aim to conduct a pilot trial assessing oral versus intravenous therapy for pleural space infections.

Pleural space infections are a frequent clinical problem resulting in significant morbidity and mortality as well as healthcare cost. Despite the increasing burden of disease, there are no clinical trials evaluating antibiotic therapy in pleural space infections. Hence, British and American guidelines are only able to provide weak and vague recommendations regarding duration, type or route (intravenous or oral) of antibiotic therapy. Our goal is to determine whether oral (PO) therapy is non-inferior to intravenous (IV) therapy thereby decreasing risks of IV catheter related infections, vein thrombosis and health care costs. Similar studies have been successfully conducted in the setting of bone/joint infections and endocarditis and showed non-inferiority of oral antibiotics. However, in order to help ensure that the randomized trial is of good quality, it is important to assess the feasibility of such a trial by first conducting a pilot study. The goal of this pilot trial is to assess the feasibility of the proposed study design.

Eligibility Criteria:
Inclusion Criteria:

* Must meet our study definition of pleural space infection
* Age \> or = 18 years old
* Life expectancy \> 1 year
* Received intravenous or oral antibiotics for = or \< 7 d from surgical intervention or received a total of = or \< 7 d of antibiotics if no intervention performed

Exclusion Criteria:

* S. aureus bacteremia or endocarditis in the last 1 month
* Another concomitant infection requiring prolonged IV antibiotics
* Esophageal rupture or malignant pleural effusion
* Septic shock or systemic features requiring IV antibiotics
* Mycobacterial, fungal or parasitic pleural space infection
* No oral antibiotic options available
* Unlikely to comply with therapy
Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection

The purpose of this study is to find out whether the study drug tocilizumab is an effective treatment for COVID-19 infection.


Eligibility Criteria:
Inclusion Criteria:

* Patient or designated proxy willing and able to provide informed consent prior to enrollment in the study.
* COVID-19 PCR positive on nasopharyngeal swab
* Aged \>/= 18 years old
* Patient hospitalized with newly diagnosed documented severe COVID-19 infection: with respiratory rate \>/= 30 breaths/min OR peripheral capillary oxygen saturation (SpO2) \< 93% on room air for nonintubated pts.
* Fever of 38.5 C or suspected respiratory infection
* IL-6 level \>/= 80 pcg/ml
* Cohort #1 - non intubated Cohort #2 - intubated
* Women of childbearing potential must have a negative serum or urine pregnancy test
* Patients receiving ongoing steroid therapy are eligible
* Patients will be allowed to receive concurrent or sequential treatment with remdesivir

Exclusion Criteria:

* Patients with uncontrolled systemic fungal and bacterial infections
* Patients with latent tuberculosis
* Patients with known hypersensitivity to tocilizumab or any component of the formulation
* Concurrent initiation of steroid therapy is not allowed
* Patients with uncrontroled malignant disease, with a life expectancy of 3 months or less
Comparison of McGrath and Macintosh Laryngoscope for DLT Intubation

The investigators previous study showed that McGrath Series 5 videolaryngoscope is an alternative tool for double-lumen tube intubation. But it is not determined about the advantages and disadvantages of McGrath Series 5 videolaryngoscope for double-lumen tube intubation, compared with traditional Macintosh laryngoscope.

The investigators designed a randomised controlled study to compare of McGrath Series 5 videolaryngoscope and Macintosh laryngoscope for DLT intubation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Thoracic surgery required one lung ventilation

Exclusion Criteria:

* Difficult ventilation
* Emergent operation