cyrilzakka/clinical-trials huggingface dataset:
Safety and Pharmacokinetics of LHT344 in Chinese Healthy Subjects

The purpose of this study is to evaluate safety and pharmacokinetics of a single and multiple dose of LHT344 in 12 Chinese healthy subjects.

This study is not recruiting subjects in the United States.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking, male or female subjects age 18 to 45 years of age
* In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
* Body mass index within the range of 19 to 24 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

* Smokers
* Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable.
* Participation in any clinical investigation within 3 months prior to dosing.
* Donation or loss of 400 mL or more of blood within 12 weeks prior to first dosing required by local regulation.
* Significant illness within 2 weeks prior to dosing.
* A past personal or close family medical history of clinically significant cardiac abnormalities such as a myocardial infarction, angina, arterial fibrillation, arrhythmia or hypertension.
* History of
* fainting, low blood pressure upon standing, irregular heart beats
* acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
* clinically significant drug allergy, history or presence of atopic allergy (asthma, urticaria, eczematous dermatitis)
* known hypersensitivity to the study drug or similar drugs
* surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or may jeopardize the subject participation in the study
* immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
* positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* drug or alcohol abuse within the 12 months prior to study participation

Other protocol-defined inclusion/exclusion criteria may apply
SubQStim: A Post-market Study of Subcutaneous Nerve Stimulation in Failed Back Surgery Syndrome (FBSS) Patients

The purpose of this study is to compare the effectiveness of peripheral nerve stimulation utilizing a subcutaneous lead implant technique (SQS) plus optimized medical management (OMM) versus OMM alone in patients suffering from back pain due to Failed Back Surgery Syndrome (FBSS).


Eligibility Criteria:
Inclusion Criteria:

1. Provides written Patient Informed Consent/Patient Information Sheet prior to study-related activities being conducted
2. ≥ 18 years of age at time of informed consent
3. Willing and available to attend visits as scheduled and to comply with the study protocol
4. Willing and able to undergo assessments as part of the evaluation for eligibility and endpoints
5. Willing and able to use the external neurostimulator, recharging equipment (if applicable), and patient programmer per the schedule required by the protocol
6. Diagnosed with FBSS (i.e.):

   * Has had persistent pain for 6 months following most recent anatomically correct, successful surgery AND
   * There are no further therapeutic surgical options available as assessed by appropriate investigation
7. Back pain is considered intractable and has been adequately treated (failed an appropriate trial of at least 3 different classes of back pain treatments (pharmaceutical and/or non-pharmaceutical))
8. Is an appropriate implant candidate for the SQS system

Exclusion Criteria:

1. Has been or is currently being treated with spinal cord stimulation, subcutaneous nerve stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
2. Evidence of an active disruptive psychiatric disorder that is significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome, as determined by the investigator
3. Has a pain condition unrelated to FBSS that is severe enough to overshadow the FBSS pain in the opinion of the investigator
4. Spinal instability or anatomic compression that requires further surgery
5. Spinal fusion at more than 3 vertebral levels
6. Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
7. Allergic or has shown hypersensitivity to any materials of the device system which come in contact with the body
8. History of coagulation disorder or lupus erythematosus
9. Involved in current litigation regarding back pain
Identification of Prognostic Biomarkers for Progression of Invasive Squamous Cell Carcinoma

The study will utilize both retrospective and prospective data collection from patients that already had a bronchoscopy and lung resection or will have a bronchoscopy and lung resection for squamous cell carcinoma. The investigators plan to prospectively collect 5 bronchoscopic biopsies, 10ml blood and one tumor and adjacent normal samples from 200 qualified patients who meet the study criteria.

The study will utilize both retrospective and prospective data collection from patients that have already had a bronchoscopy and lung resection or will have a bronchoscopy and lung resection for squamous cell carcinoma. The investigators plan to prospectively collect 5 bronchoscopic biopsies, 10ml blood and one tumor and adjacent normal samples from 200 qualified patients who meet the study criteria. If a patient has already had a bronchoscopy and has consented to have samples stored for research at the Mayo Clinic Rochester we will access them for the research study if available. Otherwise, if the patient has already had surgery and tissue has not been stored for research the investigators will consent patients to use their clinical specimens for the research study. The investigators will then extract DNA from tissue sections and blood and use a custom targeted sequencing panel of 23 cancer driver genes with significant mutations in squamous cell carcinoma that they have developed to find the prognostic biomarkers. The DNA will be used in a PCR reaction to generate amplicons for library preparation using Illumina Nextera XT library preparation protocol and targeted sequencing on the Illumina Hiseq sequencer. The reads will be aligned to the HG19 using BWA aligner and variant detection performed with Agilent SureCall and GATK analytic tools.

Eligibility Criteria:
Inclusion Criteria:

* known or suspected squamous cell carcinoma of the lung
* able to provide consent
* could have already had a bronchoscopy or surgical resection with tissue saved at the Mayo Clinic Rochester
* will be undergoing a bronchoscopy and having a surgical resection at the Mayo Clinic Rochester

Exclusion Criteria:

* unable to provide consent
* pregnant
Rehabilitation With an Obturator in Maxillary Defects

During the COVID-19 pandemic, there was a lot of reporting of COVID-19-associated mucormycosis cases. Managing this condition posed a new challenge to clinicians. Management includes therapeutic drugs and aggressive surgical debridement. Due to the unpredictability of disease prognosis and the possible recurrence of the disease, rehabilitation with delayed surgical obturators is beneficial for patients. Hence, the current study aimed to evaluate the impact of delayed surgical obturators on quality of life of COVID-19-associated mucormycosis patients post-maxillectomies

Globally, the prevalence of mucormycosis varied from 0.005 to 1.7 per million population, while its prevalence is nearly 80 times higher (0.14 per 1000) in India compared to developed countries, in a recent estimate of year 2019-2020.

Among the medical professionals involved in managing patients with mucormycosis, maxillofacial prosthodontists are responsible for prosthetic restoration of lost oral and maxillofacial structures, helping patients to socialize and have an acceptable quality of life after surgical treatment

Eligibility Criteria:
Inclusion Criteria:

\*Patients who underwent partial, subtotal and hemi-maxillectomy due to COVID-19-associated mucormycosis and who needed the prosthetic rehabilitation with delayed surgical obturator.

Exclusion Criteria:

* Patients who are unwilling for the study.
* Patients who underwent which bilateral maxillectomies.
* Patients having extensive palatal mucosal loss.
Enhancing Recovery in Non-Traumatic Spinal Cord Injury

The investigators have spent the last decade uncovering unique metabolic and functional abnormalities in the brains of patients with spinal cord compression. Degenerative spinal cord compression represents a unique model of reversible spinal cord injury. In the investigator's previous work, they have demonstrated that cortical reorganization and recruitment is associated with metabolic changes in the brains of patients recovering from spinal cord compression and is correlated with recovery and improved neurological scores.

The goal of this study is to combine a rigorous platform of clinical care that includes preoperative evaluation, surgery, and rehabilitation, with state of the art imaging techniques to demonstrate how rehabilitative therapy can increase brain plasticity and recovery of neurological function in patients with spinal cord injury. Neurological function will be carefully evaluated in two groups of patients, those receiving rehabilitation and those not receiving rehabilitation after spine surgery, and will be correlated with the results of advanced imaging.


Eligibility Criteria:
Inclusion Criteria:

* right-handed
* have a history of progressive neurological deficits \<24 months
* eligible for MRI scanning

Exclusion Criteria:

* having any other neurological disorder or systemic disease that can impair neurological function
* not fluent in reading and speaking English
* being claustrophobic
* unable to follow simple task instructions and maintain standardized movements
* being unable to return for all follow-up imaging and rehabilitation sessions
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)

The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., ReQuest™ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.


Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent
* Outpatients of at least 18 years (21 years in Argentina)
* Patient considered to have GERD symptoms

Main Exclusion Criteria:

* Acute peptic ulcer and/or ulcer complications
* Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (\> 5 days on demand but not more than 3 consecutive days) during the last 28 days before study start (except regular intake of acetylsalicylic acid at a dose up to 163 mg/day)
* Intake of proton pump inhibitors during the last 10 days before study start
* Female patients of childbearing potential not using adequate means of birth control
* Pregnant or breast-feeding females
Effects of Tobacco Flavoring and Liquid Composition on Vaping Topography

This clinical trial tests the effect of tobacco flavor and liquid composition on the way a person puffs on a vape (topography). In general, tobacco products are designed with sensory factors in mind, such as flavor, to increase the appeal. Flavors and the composition of nicotine, either made in a lab (synthetic) or from tobacco, may create positive sensory effects, such as look, feel and taste, and influence smoking behavior and willingness to try different types of cigarettes. Understanding how nicotine vaping products are used is important in assessing individual and population level health risks. Vape flavors and synthetic nicotine may be related to harmful effects on health from vaping and may impact the appeal, risk beliefs and vaping topography.

PRIMARY OBJECTIVE:

I. Examine the influence of tobacco flavoring composition on vaping topography. II. Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography.

SECONDARY OBJECTIVE:

I. Examine the influence of tobacco flavoring composition on vaping topography. II. Examine the influence of synthetic versus (vs.) tobacco derived nicotine on vaping topography.

OUTLINE:

The order of directed and ad libitum bouts are randomized within participants at each session.

SESSION 1: Participants puff their own brand liquid on study.

SESSIONS 2-5: Participants puff 1 of 4 randomly assigned tobacco flavor formulations at each visit on study.

SESSIONS 6-7: Participants puff 1 of 2 randomly assigned nicotine formulations at each visit on study.

Participants also undergo collection of saliva samples and optionally undergo collection of oral cell and oral rinse samples throughout study.

Eligibility Criteria:
Inclusion Criteria:

* Current daily vapers of products containing nicotine
* No daily concurrent use of other tobacco products
* Self-reported general good health
* Women of child bearing potential must be willing to provide a urine sample and test negative prior to receiving any study-related products/procedures
* Ability to speak, read, and write in English
* Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Allergies - active untreated seasonal allergies that would interfere with smell or taste procedures
* Self-reported taste or smell deficits
* Pregnant or nursing female participants
* Medications known to interfere with taste/smell (i.e., certain nasal sprays, nasal antihistamines, decongestants, antibiotics, medications containing zinc)
* Unwilling to use open system vaping device in laboratory setting
* Positive diagnosis of human coronavirus 2019 infection (COVID-19) within 10 days prior to start of study intervention
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive the study intervention
Vaginal Estradiol Tablets (Vagifem®) and Endometrial Cancer Risk in the Treatment of Postmenopausal Vaginal Atrophy

The study will include data from a nationwide Danish cohort of postmenopausal women and the United States of America (US) cohort of postmenopausal women. The Danish nationwide cohort will be established through linkage of Danish national patient registries. The US cohort will be established based on data from US claims database, Truven. The aim of this study is to evaluate whether exposure to Vagifem® increases the rate of endometrial cancer in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Age 50-75 years at entry

Exclusion Criteria:

1. Endometrial cancer prior to entry
2. Any use of vaginal estrogen products prior to entry
3. Hysterectomy prior to entry
A Randomized Controlled Trial:Treatments on Infundibular Ventricular Septal Defect

The purpose of this study is to investigate the security and validity of transesophageal echocardiography(TEE)-guided perventricular device closure(TPDC) through minithoracotomy in treatment of infundibular ventricular septal defect(IVSD) with asymmetric occluder.

Ventricular septal defect(VSD) , which accounted for about 20% of all congenital heart defects (CHDs) , is among the most common congenital heart malformations，among which infundibular ventricular septal defects(IVSD) is the least common type(18%）.Multiple names for IVSD are in use. They can also be labeled conal VSD, subpulmonary VSD, subarterial VSD, doubly committed VSD, intracristal VSD，or supracristal VSD. These multiple denominations are not attached to specifically different anatomic subtypes.At present, the main methods to treat the specific anatomic condition contain conventional surgical repair(SR) and transcatheter interventional closure. The former need extracorporeal circulation，thus the side effects of extracorporeal circulation are inevitable，such as on the central nervous system, respiratory system, urinary system, etc. Although the latter has the characteristics of minimally invasive, patients should be exposed in X-ray withstanding potential risk of radiation. On the other hand，there are limits with age for patients who underwent transcatheter closure because of small vessel size. Fully developed blood vessels are to reach a certain diameter, but children need be up to 3 years old or so. In addition,the aortic valve was easily injured by wire and atrioventricular block was reported.Since the surrounding structure is complicated and the defect is too high, device closure of an IVSD is difficult to succeed in transcatheter approach. Traditional repair via cardiopulmonary bypass(CBP) is widely used to treat this kind of diseases. Past decade，with the development of technology and society，TEE-guided surgical occlusion through minithoracotomy was used to treat CHDs in an increasing number of popularity，avoiding the inherent risks of cardiopulmonary bypass and radiation,etc. But it is rarely reported to treat IVSD by minimally invasive perventricular device closure without CBP.

Eligibility Criteria:
Inclusion Criteria:

(1) patients with single IVSD indicated by TTE，without concomitant cardiac malformation, serious arrhythmia or other important non-cardiac diseases；(2) patients whose ventricular septal defects from aortic residual \< 3 mm, preoperative without aortic regurgitation or only mild reflux, defect size ≤10 mm;

Exclusion Criteria:

(1) defect size \> 10 mm in diameter; （2) Preoperative with above moderate aortic valve prolapse (or) closed incompletely; (3) Eisenmenger syndrome caused by pulmonary hypertension,(4)decide temporarily to change method before surgery;(5) not signed informed consent application
Immuno-persistence Study of a Recombinant Human Papillomavirus 16/18 Bivalent Vaccine in Preadolescent Girls (54m)

The primary objective of this study is to evaluate the immuno-persistence (type specific IgG antibody) of the tested vaccine administered in girls aged 9-17 years,comparing to young healthy adults of 18-26 years who received the standard 3-dose schedule (0,1,6 months).

This is a follow-up study that is based on the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls(Unique Protocol ID:HPV-PRO-006,Identifiers: NCT02562508) .The investigators will recruit people who have participated in bridging study before and collect their serum samples to test the seroprevalence and geometric mean concentrations of anti-HPV16 and anti-HPV18 antibody on 54 months after dose 1

Eligibility Criteria:
Inclusion Criteria:

1. Participants who participated in the bridging study of a recombinant human papillomavirus 16/18 bivalent vaccine in preadolescent girls (Unique Protocol ID: HPV-PRO-006, Identifiers: NCT02562508) and received at least one dose;
2. Participants or participants and their legal guardians can fully understand the study content and sign an informed consent form；
3. Able to comply with the requests of the study;

Exclusion Criteria:

1. Participants with coagulation dysfunction (such as coagulation factor deficiency, blood-clotting disorder, or platelet disorder) or coagulation disorders, as diagnosed by a physician after vaccination ;
2. According to the investigator's judgment, there might be some medical, psychological, social or occupational factors which might impact on the individual to obey the protocol or sign the informed consent;
3. Abnormal blood clotting function or coagulopathy
Impact of Dietary Intervention on Children of ADHD at Sohag University Hospital

Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder of persistent impairment of attention, hyperactivity, and impulsivity which worsens daily functioning and quality of life , including social troubles , poor academic achievement and occupational problems .It is one of the most common psychiatric disorders between children . The prevalence of ADHD was 7.2% all over the world in 2015 and this percentage is increasing every year . In Arab countries, A systematic review of studies reported that the prevalence of ADHD ranged from 1.3% to 16%. . ADHD has been treated with medical treatment such as psychostimulants (methylphenidate and amphetamines), noradrenergic treatment as atomoxetine and alpha-2A-adrenergic agonists as guanfacine and clonidine , behavioral treatment and their combination . Due to adverse effects of medical treatments and behavioral therapy limitations, other approaches to augment multimodal ADHD management has been tested . Non medical treatment as Digital therapeutics may improve cognitive functions and attention in ADHD . Physical activity interventions for ADHD may improve cognitive , physical and psychological functions.


Eligibility Criteria:
Inclusion Criteria:

* 6-12 years children with ADHD

Exclusion Criteria:

* patient with eating disorders.

  * patients with chronic medical illness.
  * patients with IQ below 70.
  * patients who would drop out from the study

    1. if patient would be absent for 3 months,
    2. if patient would fail for any reason to continue his dietary restriction.
Physical Activity and the Risk of COVID-19 Infection and Mortality

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Currently, there is no cure for COVID-19, except for supportive treatments. Quarantine for a defined period is the best option to reduce the spread of COVID-19. Physical activity has been shown to reduce the risk of serious community-acquired infections. However, it remains unanswered is whether physical activity has protective effects against SARS-CoV-2 infection and COVID-19 related mortality. This study aimed to examine the association of PA with the morbidity and mortality of COVID-19 infection in the entire South Korean population.


Eligibility Criteria:
Inclusion Criteria:

* all Koreans who tested positive for SARS-CoV-2
* more than 18 years old
* who underwent public health screening between 2014 and 2017

Exclusion Criteria:

* missing values about physical activity