cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Immunogenicity of COVID-19 Vaccine in Chinese Population

The purpose of this study is to evaluate the immunogenicity and immune protection of COVID-19, especially the recently prevalent strains, against the background of current immunization in Chinese population


Eligibility Criteria:
Inclusion Criteria:

1. He was infected with COVID-19 from November to December 2022;
2. Have not been infected with COVID-19 (the subject said that he was not infected and signed the informed consent form);
3. Those who agree and sign the informed consent form.

Exclusion Criteria:

1. Missing or incomplete questionnaires that affect research results;
2. Individuals with combined dysfunction of important organs such as the heart, liver, and lungs;
3. Mental and behavioral abnormalities;
4. Intellectual disability;
5. Under 18 years old or over 75 years old;
6. Low understanding and communication skills.
Cerebral Reorganization of Stroke Patients After Repetitive Transcranial Magnetic Stimulation by Neuroimaging Analysis

The study aimed to figure out brain structural and functional reorganization evidence after repetitive transcranial magnetic stimulation through the method of neuroimaging brain network analysis, such as resting-state functional magnetic resonance imaging and diffusion tensor imaging.


Eligibility Criteria:
Inclusion Criteria:

1. stroke patients within 1 week after onset with unilateral cerebral subcortex lesion in the middle cerebral artery territory detected by diffusion weighted image,
2. right-handed,
3. without memory loss or intelligence disorder,
4. never suffered stroke before.

Exclusion Criteria:

1. direct damage to the cerebral cortex,
2. a history of cerebral vessel disease,
3. tendency to hemorrhage or existed brain hemorrhage,
4. epilepsy or other mental disorders,
5. any MRI contraindications.
Removable Devices in Palatal Expansion

The goal of this clinical trial si to compare two removable devices used to treat the transversal discrepancies in growing patients.

The main questions it aims to answer are:

* the efficacy of the two devices in the palatal expansion
* the neuromuscolar effects developed on the stomatognatic system Participants will be instructed in the use and maintenance of the devices and will be checked every 15-30 days for one year.


Eligibility Criteria:
Inclusion Criteria:

skeletal class I relationship, molar class I relationship; complete eruption of upper first premolars ; presence of unilateral or bilateral cross bite (falling within grade 3 IOTN index)

Exclusion Criteria:

IOTN index \>4; presence of temporomandibular disorders, epilepsy, systemic diseases, periodontal disease, absence of written informed consent signed by parents/legal guardians
Survey of Non-Variceal Upper Gastro Intestinal Bleeding in Vietnamese Patients

The main aim of the study is to describes the outcomes of patients with Upper Gastrointestinal Bleed (UGIB) in a real-life setting. Additionally analyse assessed predictors of outcome, including the impact of hemostatic endoscopic and pharmacologic therapies.

MSD

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>=18yrs) admitted to the hospital, or inpatients admitted for another reason, presenting with overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia...
* Evidence that an upper GI endoscopy was performed

Exclusion Criteria:

* GI bleeding not from NVUGIB
Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer

Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer.

Multicenter, phase III, open-label, randomized clinical trial, which will include 494 patients randomized to two neoadjuvant chemotherapy arms. The treatment protocol will be the same in both groups, only the regimens sequences will be evaluated: starting with anthracycline versus taxane, with or without carboplatin for patients with triple negative subtype. The chemotherapy regimen will follow the institution's routine, which includes the use of CA in the anthracyclical phase and, in the taxane phase, the use of docetaxel every 21 days or weekly paclitaxel. The rest of the treatment (surgery, radiotherapy, hormone therapy) will not be part of the study and will be carried out according to institutional guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Female participants, with at least 18 years old on the day of signing the free and informed consent;
* Invasive breast carcinoma stage III (RH positive) or IIB/III (RH negative), according to TNM 8th edition; Histologically confirmed diagnosis of invasive breast carcinoma (with any histology), HER-2 negative;
* The participant (or legally acceptable representative, if applicable) provides written informed consent for the study;
* The participant must agree to use a contraceptive as detailed in Appendix B of this protocol during the treatment period and for at least 120 days after the last dose of the study treatment;
* Have a functional capacity according to the Eastern Cooperative Oncology Group (ECOG) from 0 to 2. The evaluation of the ECOG must be carried out within 7 days before the inclusion date.
* Have adequate organic function. The samples must be collected within 60 days before the start of the study treatment;
* Have adequate cardiac function as assessed by echocardiogram or MUGA performed up to 60 days before the start of treatment under study.

Exclusion Criteria:

- Individuals who do not meet the inclusion criteria above-mentioned.
Open-Label Hepatic Impairment Study

This study will be conducted in Hepatitis C positive patients to determine whether the pharmacodynamic effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical studies.

This study is designed per the Food and Drug Administration (FDA) guidance for patients with impaired hepatic function to assess the influence of hepatic impairment on the PK and pharmacodynamics (PD) of PSI-7977 and PSI-352938 This study will be conducted in Hepatitis C positive patients to ascertain whether the PD effects of PSI-7977 or PSI-352938 are similar to HCV-infected patients with normal hepatic function, which may allow inclusion of patients with cirrhosis and varying degrees of hepatic dysfunction in future clinical studies. Data from subjects who participated in the P2938-0212 study (PSI-352938 MAD) will be used as the control group. These subjects were documented non-cirrhotic subjects with normal hepatic function. Hepatitis C Virus (HCV) Genotypes 1-6 will be enrolled in this study.

Eligibility Criteria:
Inclusion Criteria:

* Hepatic impaired Males or females of non-childbearing potential aged \> 18 years with Chronic HCV-infection
* Naïve to all direct acting anti-viral (DAA) treatments for chronic HCV infection.
* Documented Cirrhosis

Exclusion Criteria:

* Prior PEG/RBV null responders.
* Unstable cardiac disease, recent Myocardial infarction, or family history of QTc prolongation or unexplained cardiac arrest.
* Positive test at Screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or anti-human immunodeficiency virus (HIV) Ab.
* History of clinically significant medical condition associated with other chronic liver disease
* Any current signs or symptoms of severe hepatic encephalopathy
* History of gastric or esophageal variceal bleeding in which varices have not been adequately treated with medication and surgical procedures
* Prior placement of a portosystemic shunt
* History of hepatorenal, or hepatopulmonary syndrome.
* Active spontaneous bacterial peritonitis.
* Use of medications associated with QT prolongation within 28 days prior to dosing.
* Current Hypotension
* History of Torsades de Pointes, evidence of an active or suspected cancer, or a history of malignancy, Abnormal hematological and biochemical parameters
Long Term Evaluation and Management of Atrial Fibrillation in Pacemaker Patients

This study is prospective randomized study which was performed in multicenter (General Hospital) in Korea. Inclusion criteria is patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872). The purpose is to investigate the recurrence rate of AF/AFL/AT in both groups after randomization for 60 months (5 years) in patients post pacemaker implantation and assess long term clinical results.


Eligibility Criteria:
Inclusion Criteria:

* Patients who developed atrial fibrillation/flutter/tachycardia after pacemaker implantation among AF-pacemaker study (ClinicalTrials.gov Identifier: NCT03303872).
* Age: 18-80 years
* Patients eligible for the indications for permanent pacemaker implantation in accordance with 2016 revised Korean indication guideline on cardiac pacemaker implantation
* Estimated percentage of atrial pacing \>40% under sinus rhythm (LR≥60bpm, close hysteresis and rest rate)
* Estimated percentage of ventricular pacing \>40% under sinus rhythm (LR≥40bpm, DDD pacing, close hysteresis and rest rate)
* Patients who are willing to sign the informed consent.
* Patients who are willing to receive the implantation and post-operative follow-up.

Exclusion Criteria:

* Persistent or permanent AF
* Severe hepatic and renal insufficiency (AST or ALT ≥ three times of normal upper limit; SCr \> 3.5 mg/dl or Ccr \< 30ml/min)
* Thyroid gland dysfunction
* Pregnancy
* Malignant tumor
* Severe organic heart disease (such as moderate to severe mitral regurgitation, severe valvular regurgitation and stenosis, dilated cardiomyopathy, hypertrophic cardiomyopathy, severe heart valve disease)
* Life expectancy \< 12 months
* Patients unable or unwilling to cooperate in the study procedures.
Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia

The purpose of this study is to determine whether a posterior fossa decompression or a posterior fossa decompression with duraplasty results in better patient outcomes with fewer complications and improved quality of life in those who have Chiari malformation type I and syringomyelia.

Participants with Chiari Malformation type I and syringomyelia will be randomized to either have a posterior fossa decompression done with or without duraplasty. The participant will then return to the neurosurgeon's office at the following time points which are consistent with standard of care practice: \< 6 weeks, 3-6 months, and 12 months. At these visits, the clinician will complete a physical exam and the participant will report on the prognosis of symptoms and complete two quality of life questionnaires. A brain and cervical spine MRI will be performed 12 months after the decompression.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≤21 years old
2. Chiari malformation type I ≥5 mm tonsillar ectopia
3. Syrinx between 3 mm and 6 mm
4. Chiari Severity Index (CSI) classification 1
5. MRI of the brain and cervical and thoracic spine are required prior to surgery and must be available to be shared with the Data Coordinating Center

Exclusion Criteria:

1. CSI-2 or CSI-3 classification
2. Syrinx \<3 mm and/or ≥6 mm
3. Neuro-imaging demonstrating basilar invagination
4. Clival canal angle \<120° (signs of severe craniovertebral junction disease)
5. Chiari Malformation I + syringomyelia secondary to other pathology (e.g. a tumor)
6. Unable to share pre-decompression MRI of the brain and cervical and thoracic spine
7. Patients who do not wish to participate
Hand Grip Strength in Chilean Adults

Context Hand grip strength (HGS) is an important parameter to assess hand function during the rehabilitation of hand injuries. HGS serves as a clinical predictor of complications after surgery.

Purpose Establish HGS reference values in healthy adult Chilean population.

Study design analytical cross-sectional.

Method 311 healthy women and men, ages 18 to 65 years participated in the study. HGS was measured with a dynamometer, according to the American Society of Hand Therapists protocol. Additionally, anthropometric and labour characteristics were registered. Kruskal-Wallis test, Wilcoxon-Mann-Whitney test and multiple linear regression were used for data analysis. Significance was set at .05.

Results Median HGS in women was 26 kg and 43 kg for men. Men demonstrated 3% more HGS on the dominant versus non-dominant hand. Women's median HGS was no different between dominant versus non-dominant hand. In men and women, manual labour activity was associated with a higher HGS. The relationships between subject anthropometric measurements and HGS were different in women versus men.

Conclusions This study determined HGS in Chilean healthy adults. Results can be used as a reference standard for clinical measures related to illness, injury and rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged between 18 and 65 years;
2. capable of adopting a seated assessment posture -

Exclusion Criteria:

1. current hand or upper limb pain;
2. history of surgery, fracture, or any condition in the upper limb that could alter hand grip strength
Zinc-containing Vaginal Gel and Oral Fluconazole for Vulvovaginal Candidiasis.

Vaginitis is one of the most common gynecological problems in women. Candida albicans is responsible for more than 85% of vaginal fungal infections and reinfection after standard treatment is quite common. The aim of this study is to compare the effects of a zinc-containing vaginal gel and oral fluconazole on the treatment and recurrence of vulvovaginal candidiasis (VVC). The investigator's hypothesis is that zinc-containing vaginal gel may decrease the rate of reinfection after standard treatment with oral 150 mg fluconazole.

Randomized controlled trial will be conducted on 76 women with VVC, as confirmed by clinical and laboratory diagnosis. The participants will be allocated into two groups using blocked randomization method. In the control group participants will receive oral fluconazole treatment with a single dose of oral fluconazole (150 mg) while in the treatment group women will receive a single oral dose of fluconazole (150mg) followed by treatment with a zinc-containing vaginal gel (daily for 2 weeks and twice per week thereafter). Vaginal samples will be collected (vaginal swab and cervicovaginal lavage) at baseline and 4-8-12 weeks after starting treatment. In addition, the clinical signs and symptoms will be assessed before the intervention and follow-ups. Women will be asked to report any new symptoms of vaginal infections and will be asked to return for in-office evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy, nonpregnant female participants aged ≥18 years with a clinical diagnosis of symptomatic acute VVC.
* Positive baseline potassium hydroxide (KOH) wet mount from a vaginal smear revealing filamentous hyphae/pseudohyphae or budding yeast cells.
* Presence of ≥1 vulvovaginal sign.
* Presence of ≥1 vulvovaginal symptom.
* Composite Candida severity score of ≥4.

Exclusion Criteria:

* Abnormal Papanicolaou smear in the preceding 12 months.
* Patients who had oral or intravenous antifungal agents within 4 weeks, or used topical vaginal antifungal drugs within 1 week before the study.
* Known human immunodeficiency virus infection,
* Liver disease or abnormal liver function tests, lactation, pregnancy, and allergy to azole agents or zinc.
* Women with non-albicans Candida species will be excluded from the final data analysis.
A Randomized Clinical Trial to Investigate Whether Self Ligating Brackets or Conventional Brackets Are Better for Treating Bimaxillary Proclination

The study is a single blind randomised control trial.The patients will be randomly assigned to have conventional brackets placed or self ligating brackets placed.

All patients will undergo full Orthodontic records. This will include an Orthodontic assesment, study models relevant xrays (orthopantogram and a cephalomgram) and clinical photos. After records analysis, patients will be given a prophylaxis and oral hygiene instructions.

Either 3m Victory Series™ Metal Braces or 3m SmartClip™ SL3 Self-Ligating Braces both bracket types will carry the MBT prescription 0.022 slot height, will be bonded using Transbond™ XT (3M Unitek, Monrovia, California, USA) composite resin according to the manufactuer's instruction.

These patients will be recalled at monthly intervals for the duration of treatment time which will be 3 years. A cephalogram will be taken at the end of treatment


Eligibility Criteria:
Inclusion Criteria:

* Bimaxillary Proclination
* Class I or Class II division 1 incisor relationship with an overjet less than or equal to 6.0 mm
* The cases can be extraction or non extraction cases
* Extraction cases must be of at least both upper first premolars to relieve moderate to severe crowding and/or to reduce the overjet
* No previous orthodontic treatment
* No systemic illness
* No use of anti inflammatory drugs prior to placement of the fixed appliance
* Good oral hygiene and periodontal health with periodontal pockets of less than or equal to 4 mm, full-mouth plaque score less than or equal to 20 per cent
* Cooperative and motivated
* In the permanent dentition with all teeth present at least to the first molars
* No radiographic bone loss was observed on the dental pantomographic image.

Exclusion criteria:

* Patients who required surgery to correct skeletal discrepancies.
* Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).
* Uncooperative patients
Transparent Elastomeric Respirator for Aerosol-based Protection

In times of crisis, diminishing supplies of personal protective equipment (PPE) in hospitals has forced both healthcare workers and the general population to reuse and clean PPE using anecdotal strategies which may weaken its effectiveness of preventing acquisition of airborne respiratory illnesses, such as COVID-19. There is therefore a great need to develop innovative measures to generate reusable PPE that can be safely cleaned and sterilized. A novel reusable injection molded respirator will be evaluated using qualitative and quantitative fit tests to assess overall fit and comfort.

PPE is the last line of defense in the hierarchy of controls to prevent the spread of airborne transmissible infections. There are many varieties of respirators including quarter-mask, half mask, and full facepiece respirators that filter 95, 99, or 100% of airborne particles. The elastomeric half mask respirators (EHMRs), in particular, have several advantages over commonly used N95 FFRs. Firstly, EHMRs may be cleaned, disinfected, and reused unlike FFRs that are normally discarded after a single use. EHMRs may be transparent as a result of material choice and will allow for visualization of the mouth. Lastly, they have been shown to properly fit faces after multiple rounds of decontamination.

Some disadvantages of EHMRs include the requirement to disinfect and reinspect the quality of components on the respirator by a qualified individual for proper function, as well as manual exchange of filter components. Notwithstanding, it has been found that fit testing and training to use EHMRs for healthcare personnel is not significantly different than N95 respirators and that EHMR may serve as a suitable alternative to disposable N95 respirators during public health emergencies. Furthermore, a 2018 consensus report from the National Academies of Engineering, Science, and Medicine recommended that the durability and reusability of elastomeric respirators made them desirable for stockpiling for emergencies.

A new transparent elastomeric respirator has been developed that can maintain respirator integrity after decontamination and fits many people with different face sizes and shapes. Fit testing of the respirator will be performed using an OSHA-approved testing method.

Eligibility Criteria:
Inclusion Criteria:

* Healthcare workers that have undergone successful fit test with N95 FFR within 1 year of the trial

Exclusion Criteria:

* Facial hair
Measuring Acute Drug Demand in Humans

This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.

This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs. Suvorexant is not approved as a treatment to reduce drug use but is approved by the Food and Drug Administration (FDA) to treat insomnia (trouble falling asleep or staying asleep). This study consists of a screening visit and an approximate 14 to 16 day inpatient (overnight) stay at the Johns Hopkins Bayview Medical Center. Participants will be stabilized on hydromorphone, randomly assigned to receive either suvorexant or placebo, and complete 5 experimental sessions that include taking blinded study medications.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years old
* Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe)
* Lifetime substance use history criterion \[blinded\]
* Medically cleared to take suvorexant and blinded study medications
* Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests

Exclusion Criteria:

* Pregnant or breast feeding
* Seeking opioid use treatment
* Significant mental health or physical disorder that is expected to interfere with study participation as assessed by the study physicians or medical staff
* Known contraindications or allergies to suvorexant and/or the blinded study medications
Copper Balance in Healthy Participants Administered ALXN1840

The study will assess the change from baseline in mean daily copper balance in healthy participants with repeat-dose administrations of ALXN1840 over 2 weeks.

This study will also characterize the steady state absorption, distribution, metabolism, and excretion (mass balance) of total molybdenum, which is a surrogate measure of ALXN1840 disposition.

Safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Have regular bowel movements (at least once per day).
2. Adequate venous access in the left or right arm to allow collection of study-required blood samples.
3. Willing and able to adhere to all dietary requirements of the study.
4. Body weight between 50 to 70 kilograms (kg) (inclusive) for female participants, and 65 to 85 kg (inclusive) for male participants, and body mass index within the range 18 to 25 kg/meters squared (inclusive).
5. Willing and able to follow protocol-specified contraception requirements.
6. Capable of giving signed informed consent.

Exclusion Criteria:

1. Significant medical history (current or past).
2. History or presence of gastrointestinal conditions including chronic constipation and irritable bowel syndrome.
3. Supine blood pressure ≤ 90/60 millimeters of mercury (mmHg) or \> 140/90 mmHg.
4. Lymphoma, leukemia, or any malignancy within 3 years.
5. Breast cancer within the past 10 years.
6. Alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> upper limit of normal at Screening.
7. Serum copper or serum ceruloplasmin below lower limit of normal on laboratory reference range at Screening.
8. History of anemia or hemoglobin \< 130 gram (g)/Liter (L) for men and hemoglobin \< 115 g/L for women at Screening.
9. History of benign ethnic neutropenia or absolute neutrophil count \< 1500/microliter (uL), lymphocyte count below 1000/uL.
10. QTcF\> 450 millisecond (ms) for men and QTcF\> 480 ms for women.
11. Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for asymptomatic gallstones).