cyrilzakka/clinical-trials huggingface dataset:
A Multicenter, Randomized, Double-blind, Parallel Group Study to Determine the Optimal Dose of HL301 After 7 Days Oral Administration in Acute Bronchitis or Acute Exacerbations of Chronic Bronchitis Patients (HL301: Mixed Extract of Rehmannia Glutinosa, Schisandra and so on)

The purpose of this study is to determine the optimal dose of HL301 in patients with acute bronchitis or acute exacerbations of chronic bronchitis.

- BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation of symptoms of cough and sputum


Eligibility Criteria:
Inclusion Criteria:

1. Both gender, 19 years ≤ age ≤ 80 years
2. Acute bronchitis or acute exacerbations of chronic bronchitis patients with BSS(Bronchitis Severity Score)\* ≥ 5point at Visit1 and Visit2
3. Written consent voluntarily to participate in this clinical trial

Exclusion Criteria:

1. Patients who were increased the bleeding tendency
2. Patients with any of Alanine aminotransferase, Aspartate aminotransferase or serum Blood Urea Nitrogen, Creatinine\> 2 times of the normal upper range
3. Patients who investigators determines to severe respiratory disease that would interfere with study assessment
4. Patients with COPD(Chronic Obstructive Pulmonary Disease) history of stage 3 or more
5. Patients who were treated with oral systemic adrenocortical hormone or immunosuppressive drug within 4 weeks prior to study participation
6. Patients who were treated with oral β2-agonist, anticholinergic, Methylxanthine, antibiotics, antihistamines, sympathomimetic agent or oriental medicine/health functional food for antitussive and mucolytic Effect within 1 weeks prior to study participation
7. Patients who were treated with oral Antitussive, Mucolytic Agents,systemic antimicrobial agent within 3 days prior to study medication dosing
8. Patients with drug or alcohol abuse
9. Patients with clinically significant active liver, renal, cardiovascular, respiratory, endocrine, central nervous system disease or history of malignant tumor or mental illness(except no relapse for 5 years after surgery)
10. The aged person with severe medical history which is mental disorder(dementia), cancer, chronic renal failure, chronic liver failure
11. Pregnant or breast-feeding
12. Patients currently participating in or has participated in other clinical study within 30 days prior to study participation
13. Patients who investigators determines not appropriate to take part in this clinical study
DNA Vaccine for Ragweed Allergic Adults

Various chemical modifications of allergens have been attempted to enhance efficacy, improve safety, and foster compliance with IT. These approaches have been unsuccessful - in that the allergenicity and immunogenicity have either decreased, or increased in tandem, with no resultant efficacy: safety benefit ratio. This study utilizes an adjuvant approach in which synthetic immunostimulatory DNA is conjugated to ragweed allergen in an attempt to modulate both the clinical and immunologic allergic response to ragweed exposure in ragweed-allergic patients with seasonal rhinitis.

Evaluation of efficacy and safety of allergen-CpG oligonucleotide immunostimulatory conjugate in treatment of ragweed-induced seasonal allergic rhinitis. Study incorporates clinical outcomes (symptom diaries, medication diaries, visual analog scores, quality of life questionnaires), safety measurements, immunologic assays (antibody measurements, T-cell assays, cytokine assays, nasal provocation).

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women 18 to 60 years of age;
* Who provide informed consent;
* Have a history of fall, seasonal, allergic rhinitis consistent with ragweed allergy;
* Exhibit a positive skin test to licensed , standardized, ragweed extract and a positive acute response to ragweed nasal challenge;
* Are in general good health; and are available for the duration of the study.

Exclusion Criteria:

* Individuals with medical conditions or taking medications that might interfere with interpretation of the study results will be excluded.
* Those with a history of severe symptoms of allergic rhinitis during the spring and summer grass pollen season will be excluded.
Anti-HIV False Positivity Rate in Pregnant Women; and Investigating the Factors Affecting This Situation

HIV virus is an etiologic agent of ( AIDS ) immunodeficiency syndrome . It is known that the estimated rate of transfer from mother to baby is 25% to 45%, pregnancy rate is 5-10%, pregnancy rate is 15-20% and in lactation period is 5-10%. Risk factors; maternal viral load, breastfeeding, vaginal birth, and prematurity. Although there is a high rate of false positivity in prenatal screening in our country, one of the factors affecting this is the number of pregnancies.


Eligibility Criteria:
Inclusion Criteria:

* Anti HIV seropositive Pregnant Women

Exclusion Criteria:

* Anti HIV seronegative Pregnant Women
Predictors of Inhaled Nitric Oxide Responsiveness in Patients With PPHN

To identify biochemical, clinical, or genetic biomarkers that may predict responsiveness to iNO in neonates with PPHN/HRF. The primary outcome will be identification of any biomarker(s) associated with response to iNO therapy. We will evaluate related biomarkers at various time-points during disease progression and in response to therapy, including single nucleotide polymorphisms in the cyclic adenosine monophosphate/cyclic guanosine monophosphate-Phosphodiesterase (PDE) pathway, indicators of metabolic dysregulation and inflammation, as well as biochemical markers of heart strain. We will perform targeted neonatal echocardiograms to evaluate severity of PPHN and heart function both as an added clinical biomarker and to follow disease progression.

A single-center, prospective observational cohort study evaluating potential biochemical, clinical, and/or genetic biomarkers in neonates admitted with a diagnosis of PPHN that may predict iNO response. Thus, it is important to collect data prior to the initiation of iNO to be able to identify biomarkers that can predict response. For patients who meet the screening criteria and when consent is not attainable prior to initiation of the potential life-saving iNO therapy, then samples will be obtained with deferred written informed parental consent obtained within the first 4 hours after enrollment. These patients will have one sample of blood, urine, and tracheal aspirate (if available) collected. If the patient meets the inclusion and exclusion criteria, the patient will be recruited for study participation. To ensure no delay in care or in the initiation of the only FDA-approved vasodilator for this population, iNO, a deferred written informed parental consent is requested to allow for the collection of blood, urine, tracheal aspirate specimens (if available) prior to the initiation of iNO. Only one sample of blood and tracheal aspirate specimens will be collected prior to the deferred consent. Samples are often collected during the routine collections that are obtain from patients who are critically ill such as in our study participants, therefore, no additional discomfort will be expected from this study. Urine collection will be from cotton ball collection that would normally be discarded and is noninvasive. All data and biospecimens obtained from eligible infants whose parent(s) decline consent or do not qualify for the study will be discarded.

Eligibility Criteria:
Inclusion Criteria:

1. Greater than 34 weeks gestational age.
2. Less than or equal to 10 postnatal days of age.
3. Echocardiographic evidence of PPHN (right-to-left or bidirectional shunt at the foramen ovale or the ductus arteriosus and/or severe tricuspid regurgitation)

Exclusion Criteria:

1. Lethal congenital anomalies, obvious syndromic or chromosomal disorders.
2. Congenital diaphragmatic hernia.
3. Congenital heart defect (except a small atrial septal defect, ventricular septal defect, and/or PDA).
An Observational Retrospective Study to Evaluate Treatment Patterns of Botulinum Toxin Type A

This is a retrospective chart review to evaluate treatment patterns of botulinum toxin Type A for the treatment of facial lines.


Eligibility Criteria:
Inclusion Criteria:

* Previously treated for glabellar lines (hyperfunctional facial lines) with botulinum toxin Type A preparation
* Received 2 treatment cycles wtih botulinum toxin Type A (BOTOX®) prior to at least 1 treatment with botulinum toxin Type A (Xeomin®)

Exclusion Criteria:

* None
A Comparative Study of 3-point With 1-point Mesh Fixation in TAPP for Gilbert Type III Inguinal Hernia

This study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in TAPP surgery for patients with type Ⅲ gilbert inguinal hernia. The main outcome include seroma, chronic pain, recurrence, et al.


Eligibility Criteria:
Inclusion Criteria:

Unilateral indirect inguinal hernia according to preoperative physical examination and imaging examination.

The inclusion criteria were as follows: primary indirect inguinal hernia classified as Gilbert III (defect size diameter ≥3cm, including scrotal hernias)

Exclusion Criteria:

Age below 18 years or older than 80. Direct hernia, femoral hernia, recurrent hernia, incarcerated hernia, strangulated hernia, and other types of hernias.

Patients not suitable for general anesthesia. Patients requiring open surgery; patients requiring emergency surgery Loss to follow-up or communication difficulties, or poor compliance.
A Prospective, Non-interventional Cohort Study of Subsolid Pulmonary Nodules

Some studies have shown that the model for judging and predicting the growth of sub-solid pulmonary nodules through big data and deep learning can detect nodule growth earlier. Since most of the training data come from large foreign samples, most of the validated data are CT data from a single center or a few centers, and their generalization ability needs to be further verified. In order to better study subsolid pulmonary nodules in the lungs in China, we plan to conduct a prospective, multicenter, non-interventional observational cohort study.

Through the follow-up of pulmonary nodules, artificial intelligence based on CT was used to study the natural evolution process of subsolid pulmonary nodules, as well as the development law and prognosis of pulmonary subsolid nodules under treatment or no treatment according to clinical guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Age≥ 18 years old, gender is not limited
* Confirmed subsolid pulmonary nodule by CT, initial pulmonary nodule ≥ 5 mm (including subsolid components) and ≤ 30 mm, do not shrink or disappear after 3 months Follow-up.
* ECOG 0～2
* Able to provide CT in DICOM format
* Informed consent obtained

Exclusion Criteria:

* Long-term use of immunosuppressants and hormone drugs
* History of previous malignancy (if there is no recurrence or carcinoma in situ for more than 5 years after receiving curative therapy, it can be enrolled)
* Inability to cooperate with regular follow-up
* Poor general condition, with the life expectancy less than 6 months
A Study Evaluating the Sonendo GentleWave™ System

A post market, observational study evaluating the treatment of 1st and 2nd molars indicated for root canal therapy and treated with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal.


Eligibility Criteria:
Inclusion Criteria:

* The patient is 18 years of age or older
* The subject tooth has been treated for root canal therapy with the Sonendo GentleWave System and obturated with CPoint and BC Sealer in at least one canal
* The subject tooth is a 1st or 2nd molar

Exclusion Criteria:

* Vertical fracture, horizontal fracture, or perforation extending below the Cemento-Enamel Junction (CEJ) of the subject tooth
* Subject tooth having previous or attempted pulpectomy or root canal therapy
Pictorial Warning Labels, Numeracy, and Memory for Numeric Cigarette Health-risk Information Over Time

Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but experimental research has not examined PWLs' longer term effects on memory for health risks, or for numeric risks (e.g., percentage risk for developing lung cancer). This trial tests memory for numeric health risks immediately or after a six-week delay for US adult smokers. In addition, the trial tests the effects of different warning label components (e.g., whether the numeric risks are percentage or frequency), participants' level of numeric ability, and the consequences of memory for numeric risks on participant risk perceptions and quit intentions.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* have smoked 100+ lifetime cigarettes
* currently smoke "every day" or "some days."
* US resident

Exclusion Criteria:

* have not ever smoked a cigarette
Adaptation of a Cognitive Training Intervention for Diabetes Self-Management

The aims of this project are: (1) to refine an existing cognitive rehabilitation intervention and tailor it for persons with T2DM by using current literature and interview data from 10 participants with T2DM and (2) to conduct a feasibility study of the adapted intervention with 20 participants with T2DM. The intervention consists of 8 weekly group educational sessions to teach compensatory cognitive strategies. Participants will also use a web-based, game-like program to build on the didactic information and practice activities to improve cognitive health.

Type 2 diabetes mellitus (T2DM) increases the risk for cognitive impairment and doubles the rate of cognitive decline after diabetes is diagnosed. In turn, the presence of cognitive dysfunction can make diabetes self-management more difficult. Few interventions have attempted to focus on cognitive function in the context of diabetes and none, to date have tested an intervention to improve cognition in order to improve diabetes self-management. Therefore the aims of this project are: (1) to refine an existing cognitive rehabilitation intervention and tailor it for persons with T2DM by using current literature and interview data from 10 participants with T2DM and (2) to conduct a feasibility study of the adapted intervention with 20 participants with T2DM. The intervention consists of 8 weekly group educational sessions to teach compensatory cognitive strategies. Additionally, participants will use a web-based, game-like program to build on the didactic information and practice activities to improve cognitive health. The project will provide baseline data for further research on diabetes self-management in the context of cognitive dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 70
* Have been diagnosed with type 2 diabetes for at least 2 years
* Score of at least 10 on the Perceived Deficits Questionnaire
* Read and write in English
* Have access to transportation and telephone and Internet services

Exclusion Criteria:

* limitations that preclude study activities
* have been diagnosed with dementia or disorders that can affect cognition such as depression
* type 1 diabetes
Study in NSCLC: is Timely Analysis of EGFR-mutation Status Feasible in Region Antwerp, Belgium.

This is an observational study to evaluate the feasibility of the implementation of a personalized treatment strategy based on specific tumor marker (f.i. EGFR-mutation) in the routine clinical care setting in the Antwerp region (Belgium).

The favourable results of a number of phase III-trials with gefitinib in NSCLC patients with activating EGFR-mutations, have resulted in the licensing of gefitinib in this indication. This offers the prospect of a true personalized treatment of patients with NSCLC. Implementation of such a personalized treatment strategy is dependent both on the availability of adequate tumor samples for the EGFR-mutation analysis and on the timely reporting of the mutation analysis results. Ideally the results should be available in all patients within 2 weeks of the analysis request.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or above
* newly diagnosed NSCLC
* written informed consent
* tumor sample available

Exclusion Criteria:

* mixed histology of small cell and NSCLC
A Prospective, Multi-center Clinical Study to Establish Multi-Cancer Early Detection Platform Through the Analysis of Whole Genome Sequencing of Circulating DNA in Cancer Patients and Healthy Volunteers

This is a prospective, multi-center clinical study of Multi-Cancer Early Detection (MCED) testing in cancer patients and healthy volunteers. The purpose of this study is to establish MCED platform through the analysis of whole genome sequencing of circulating DNA.

The study will enroll 4,000 subjects as defined by eligibility criteria at up to 10 clinical institutions in South Korea.

AIMA is analysing whole genome sequencing data of circulating tumor DNA, combined through machine learning technique, to develop MCED platform to detect early stage cancer.

The purpose of this prospective, multi-center, observational study is to validate an MCED platform for the early detection of cancers.

The investigators will collect blood samples from subjects who are diagnosed as invasive cancers before treatment or from healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Aged 19 years or older
* Subjects who have been diagnosed with stages 1 to 4 of solid tumor or healthy volunteers who have scheduled a cancer screening examination
* Subjects who have agreed to provide clinical information and blood samples
* Subjects who have agreed for the storage and secondary use of residual blood samples for research
* Subjects who have understood the study and are able to provide a written informed consent

Exclusion Criteria:

* Subjects who are not appropriate for the study because of intellectual disabilities or severe mental disorders
* Subjects with a history of HIV, HTLV, or Syphilis infection
* Subjects with primary site unknown cancer or synchronous or metachronous double primary cancers
* Subjects who have diagnosed with any other malignant tumor within the past 5 years (except for cured non-melanoma skin cancer, in situ cancer, or thyroid cancer)
Childhood Anesthesia and Cognitive Function

The purpose of this study is to determine whether pediatric anesthesia is associated with long-term hippocampal dysfunction

Contrary to a longstanding belief, anesthesia has lasting effects on the neonatal brain. In rats anesthesia causes death of brain cells, ill-timed conversion of stem cells to nerve cells and a certain kind of brain defect up to 8 months later. This brain defect is called a hippocampal deficit because it resembles the type of defect that people have when a structure in the brain called the hippocampus has been injured, removed or is no longer functioning. However, to date it is unknown if anesthesia given to human infants causes a lasting hippocampal deficit, which might manifest itself as memory problems and academic failure despite normal intelligence. The investigators will test the hypothesis that anesthesia for more than 2h given to children of less than 2 years of age without coexisting diseases of the brain or the heart causes long-term impairment of hippocampal function. Using state of the art hippocampal and general brain function testing the investigators will compare hippocampal dependent and hippocampal independent memory as well as general cognitive function and emotional state in 10 year-old children that underwent at least a 2h anesthetic at less than 2 years with that of a matched control group that did not undergo an anesthetic.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesia at less than 2 years of age
* Anesthetic time greater than 2 hours
* ASA I or II
* Induction with Propofol or Sevoflurane +/- N2O
* Maintenance with a volatile agent (sevoflurane, isoflurane, desflurane) +/- N2O

Exclusion Criteria:

* Neurosurgery
* Known genetic syndrome
* Any other anesthetic agents (ketamine, meperidine, barbiturates, etomidate, methoxyflurane, methadone, lorazepam)
* Low birthweight (\<25%ile)
* Gestational age , 36 weeks
* color blindness
* h/o CNS disease
* cancer
* head trauma
* congenital heart disease
* ASA III or IV
* intra-operative hypotension (\<30% baseline for \> 5 min)
* Bradycardia (\<30% baseline for \> 5 min)
* Hypoxemia (Blood Oxygen Saturation \<93% for \> 5 min)
* Hypercarbia (pCO2 \> 60 mm Hg \> 5 min)
* Dysthermia (deviation from 36.5 deg C by \> 1.5 deg C at any time)
* Puberty
Physical Activity to Reduce Diabetes Risk in Serious Mental Illness

The aim of this project is to trial the protocol of a park-based physical activity (PA) intervention in adults with severe mental illness (SMI) in a community mental health center's peer support program.

Aim 1: Test the feasibility and acceptability of a park-based PA intervention led by Certified Peer Specialists (CPS) and adapted for adults with SMI. Rationale: Park-based interventions led by CPSs represent a novel approach to increase program satisfaction and adherence to PA behavior change in persons with SMI. Hypothesis 1A: Most (80%) people offered the intervention will participate most of the time (≥2 day/week). Hypothesis 1B: CPSs and SMI patients will express satisfaction with the program (6 on an 8-point scale). Aim 2: Test the effectiveness of a park-based PA intervention led by CPSs on increasing PA and improving fitness in adults with SMI. Rationale: Park-based PA is associated with greater intensity and duration of PA, better fitness, and less obesity and depression, issues that are especially problematic for adults with SMI. Hypothesis 2A: People enrolled in the intervention will engage in more PA than at baseline (90min moderate to vigorous PA (MVPA)/week). Hypothesis 2B: The intervention will result in improved fitness (6 min walk test) relative to baseline.

Eligibility Criteria:
Inclusion Criteria:

* Authorized for peer group treatment through the Serenity behavioral health facility
* Medically cleared for participation
* Able to act as their own legal guardian

Exclusion Criteria:

* Age under 18