cyrilzakka/clinical-trials huggingface dataset:
Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled Study

The purpose of this trial is to study the effect of Human Papillomavirus (HPV) vaccination on the elevation of antibody titer to 4 serotypes of HPV in patients with systemic lupus erythematous and compare the antibody response with an equal number of age-matched healthy women.

Genital infection with human papillomavirus (HPV) is one of the most common sexually transmitted infections in Hong Kong. Most cases of HPV infection are asymptomatic. However, in some individuals, especially those patients who are immunocompromised, HPV infection is persistent and may result in genital warts, cervical smear abnormalities, cervical intraepithelial neoplasia (CIN) and rarely cervical cancer.

Systemic lupus erythematosus (SLE) is a disease that predominantly affects women of the childbearing age. Patients with SLE are at risk of persistent HPV infection. This is because of the immunosuppressive state induced by various treatments. The prevalence of abnormal Pap smears and cervical squamous intraepithelial neoplasia (CIN) in SLE patients is higher than that in age-matched healthy women. Thus, prevention of HPV infection is important in patients with SLE to reduce the incidence of CIN lesions and hence invasive cervical cancers in the long run.

The quadrivalent HPV vaccine, GARDASIL is effective in reducing the occurrence of high-grade CIN lesions and anogenital disease elated to HPV-16 and HPV-18 infection. Vaccination of young women aged 16 to 23 years resulted in seroconversion rates of more than 99% for all the HPV types (6,11,16,18) and was well tolerated. There has been very little information regarding the efficacy of the quadrivalent HPV vaccine in immunocompromised hosts. The objectives of the current study are to evaluate the immunogenicity and safety of the quadrivalent HPV vaccine in a group of patients with SLE in terms of antibody conversion. Comparison will be made with an equal number of age-matched healthy women.

Eligibility Criteria:
Inclusion Criteria:

SLE patients

* Female patients aged ≤ 35 years
* Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE
* Having received a stable dose of prednisolone and/or other immunosuppressive agents within 3 months of study entry
* Able to give written informed consent

Controls

* Women aged ≤ 35 years, matched those of SLE patients recruited
* No known chronic medical diseases
* Not receiving any long-term medications including herbs

Exclusion Criteria:

* History of allergy to HPV vaccines
Media Project and Health Study - Spanish Version

We seek to test the efficacy of the Spanish version of the "Catalina" web-app intervention compared to an attention control web-app in reducing symptoms of depression and/or anxiety and motivate women to take action to get help.


Eligibility Criteria:
Inclusion Criteria:

* self identifies as Latina
* scores 10 or more on Patient Health Questionnaire-8 (PHQ-8) or General Anxiety Disorder (GAD)-7
* can read, write, and speak Spanish
* has access to the internet

Exclusion Criteria:

* currently getting treatment for depression or anxiety
* suicidal ideation identified at screening
Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones

Small exploratory open-label pilot study to assess supplementation of a ketone ester (KetoneAid) as a potential therapy for persons with Parkinson disease (PD), Parkinson Disease Dementia/Lewy Body Dementia (PDD/LBD), and healthy controls.

The overarching goal of this study is to investigate glucose metabolic, cognitive, clinical and imaging changes in persons with PD and PDD/LBD before and after a month supplementation of a ketone ester (KetoneAid) in a small open label exploratory clinical trial. Positive findings in this small exploratory pilot trial may support future target engagement studies of ketone supplementation in PD and normal adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy control volunteers over 45 years of age
* People with Parkinson Disease over 45 years of age
* People with Parkinson's Disease Dementia or Lewy Body Dementia over 45 years of age

Exclusion Criteria:

* Participants with contra-indications to MR imaging, including pacemakers or claustrophobia;
* Evidence of large vessel stroke or mass lesion on MRI
* Regular use of anti-cholinergic, benzodiazepines, high dose (\>100mg QD) of quetiapine, or neuroleptic drugs
* History of significant GI disease
* Significant metabolic or uncontrolled medical comorbidity
* Poorly controlled diabetes
* Pregnancy or breast feeding
* Current excessive alcohol use
* Suicidal ideation
Molecular Studies on Hereditary Haemorrhagic Telangiectasia Families

This study will examine genes involved in the vascular dysplasia Hereditary haemorrhagic telangiectasia i(HHT)

Hereditary haemorrhagic telangiectasia (HHT) is a condition inherited as an autosomal dominant trait. Sequencing DNA from affected and unaffected family members allows us to identify disease-causal genes. Sequencing these genes allows us to identify what the precise DNA variants are which are causing disease, particularly if linked to functional assays in separate studies.

Eligibility Criteria:
Inclusion Criteria:

* Member of family affected by HHT

Exclusion Criteria:

* Unable or unwilling to provide informed consent for DNA sample
Splinting Versus Not Splinting of the Distal Lower Extremity After Intramedullary Nailing for Tibial Fractures

Two standards of care exist with regards to posterior splinting post-operatively. The proponents of splinting feel the additional immobilization decreases the stress on the soft tissue, subsequently preventing or limiting pain while improving early range of motion (ROM). The opposing belief is that the splinting is without therapeutic benefit and that early mobilization is beneficial. With regards to both practices, the surgeon's practice is anecdotally based on past experience.

The purpose of this study is to compare the results obtained with and without posterior splinting after intramedullary (IM) nailing for tibia fractures in order to provide evidence based reasoning to guide future practice.


Eligibility Criteria:
Inclusion Criteria:

* Isolated tibia fracture that is open grade II or less and all closed tibia fractures that are amenable to treatment with an IM nail

Exclusion Criteria:

* Pregnant Women
* Prisoners
Remote-controlled Capsule Endoscopy: a Feasibility Study

The present study is a feasibility study to assess the safety and efficacy of wireless capsule endoscope and compare the data obtained with those obtained by using a conventional esophagogastroduodenoscopy.

The product was developed and manufacture in China.(the NaviCam. AKC-1.China)


Eligibility Criteria:
Inclusion Criteria:

* upper abdominal symptoms (≥1 year )
* surveillance gastroscopy for known gastric ulcer or polyps
* history of gastric ulcer or polyps （≤1w）at Nanfang Hospital were enrolled.

Exclusion Criteria:

* dysphagia
* suspected or documented digestive tract malformation ,obstruction, strictures or fistula
* acute upper GI bleeding, acute enteritis, acute ischemia disease
* history of abdominal operations
* impaired renal function, congestive heart failure
* patients with critical condition or mental illness
* patients with, known allergy to polymer material or antifoam agent
* patients with cardiac pacemakers or other implanted electromedical devices，magnetic resonance imaging ( mri) examination in 7 days
* pregnancy
Evaluation Freethiadine Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study

The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug Freethiadine in Healthy subjects and in patients with chronic hepatitis B


Eligibility Criteria:
Inclusion Criteria:

Health volunteer:

1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
2. subjects and must be 18 to 45 years of age inclusive.
3. Body weight ≥ 45 kg and body mass index（BMI）between 18 and 28 kg / m\^2, inclusive.
4. Physical examination and vital signs without clinically significant abnormalities.

Patients with chronic hepatitis B:

1. Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.
2. subjects and must be 18 to 65 years of age inclusive.
3. Body mass index（BMI）between 18 and 32 kg / m\^2, inclusive.
4. No cirrhosis.

Exclusion Criteria:

Health volunteer:

1. Use of \>5 cigarettes per day during the past 3 months.
2. History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).
3. Donation or loss of blood over 450 mL within 3 months prior to screening.

Patients with chronic hepatitis B:

1. AFP\>50 ng/mL.
2. INR\>1.5.
3. Positive for Viral hepatitis C, HIV and syphilis.
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection

This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics following single and/or multiple doses of RO7565020 in healthy participants and/or virologically suppressed participants with chronic hepatitis B (CHB).


Eligibility Criteria:
Inclusion Criteria:

Healthy volunteers:

* Healthy participants
* Body mass index (BMI) between 18 and 32 kg/m\^2

CHB participants:

* CHB infection (HBsAg-positive for \>/= 6 months)
* On NUC (ETV, TAF, or TDF) monotherapy for \>/= 12 months
* Liver biopsy, FibroScan, or equivalent test within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis
* BMI between 18 and 32 kg/m\^2

Exclusion Criteria:

Healthy volunteers:

* History of any clinically significant disease
* Concomitant disease that could interfere with treatment or conduct of study
* Use of any treatment within the 2 weeks or within 5 half-lives prior to first dosing (whichever is longer)

CHB participants:

* Evidence of liver cirrhosis or decompensated liver disease
* History or suspicion of hepatocellular carcinoma (HCC)
* History or evidence of a medical condition associated with chronic liver disease other than HBV infection, or clinically significant and not adequately controlled non-hepatic disease
* History of or currently receiving any systemic anti-neoplastic or immune-modulatory treatment within the 8 weeks prior to the first dosing or the expectation that such treatment will be needed at any time during the study.
Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)

The purpose of this study is to evaluate the safety, and tolerability of HLA-A\*2402 restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination with gemcitabine

Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and in vivo. According to these findings, in this trial, we evaluate the safety, tolerability and immune response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS

1. Locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
2. Measurable disease by CT scan

PATIENTS CHARACTERISTICS

1. ECOG performance status 0-2
2. Life expectancy \> 3 months
3. Laboratory values as follows:

   * 2,000/mm3 \< WBC \< 15000/mm3
   * Platelet count ≥ 750,000/mm³
   * Total Bilirubin ≤ 1.5 x
   * Aspartate transaminase \< 150 IU/L
   * Alanine transaminase \< 150 IU/L
   * Creatinine ≤ 3.0 mg/dl
4. HLA-A\*2402
5. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
2. Breast-feeder
3. Active or uncontrolled infection
4. Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
5. Serious or uncured wound
6. Active or uncontrolled other malignancy
7. Steroids or immunosuppressing agent dependent status
8. Interstitial pneumonia
9. Ileus
10. Decision of unsuitableness by principal investigator or physician-in-charge
Effects of Different Types of Anaesthesia on Intraocular Pressure During Lumbar Disc Herniation Surgery

The aim of this study was to investigate the effects of anaesthesia methods on intraocular pressure during lumbar disc surgery performed in the prone position.

The study included 75 patients with lumbar disc herniation between the ages of 18-75, with the American Society of Anesthesiologists (ASA) 1-2. The patients were randomly divided into 3 groups: propofol, desflurane, spinal. Intraocular pressure (IOP) was measured at 5 time points throughout surgery, including baseline (T1), 10 minutes after anesthesia (T2), 10 minutes after prone positioning (T3: early prone), 30 minutes after prone positioning (T4: late prone), and 10 minutes after returning to the supine position (T5). Hemodynamic parameters were measured at these time points. Hemoglobin and hematocrit values were measured preoperatively and on the first postoperative day.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-2 according to the American Society of Anesthesiologists (ASA) Classification.

Exclusion Criteria:

* Who did not sign the informed consent form,
* patients who required emergency surgery,
* eye surgery recipients,
* subjects with acute or chronic eye diseases other than refractive errors,
* individuals detected to have elevated IOP in preoperative measurements
Binaural Beat Music Combined With Rhythmic Photic Stimulation on Depression

Background: Previous studies have suggested that non-pharmacological treatments, such as binaural beat music (BBM) and rhythmic photic stimulation (RPS), may help improve depressive symptoms and enhance quality of life. However, their effectiveness in elderly patients with depression remains unclear.

Objectives: This study aims to investigate the effects of combining BBM and RPS on improving depression, quality of life, and heart rate variability (HRV) in elderly patients with depression.

Methods: This study was conducted as a single-blind randomized controlled trial. Forty-eight elderly patients with depression were recruited from a long-term care institution in Taiwan and randomly assigned to either the BBM and RPS group or the Sham group. Participants received 20 minutes of intervention daily, Monday to Friday, for 12 consecutive weeks. During the intervention, participants in the BBM and RPS group listened to 10Hz BBM (embedded with classic old songs) and wore RPS glasses that provided 10Hz light stimulation. In contrast, participants in the Sham group listened to classic old songs and wore RPS glasses without the 10Hz light stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for this study were:

A) Diagnosed with major depressive disorder by a psychiatrist and stable for more than six months; B) Aged 65 and above; C) No cognitive impairment, with a Mini-Mental State Examination (MMSE) score above 24 and able to understand the questionnaire content; D) No severe physical illnesses and no significant hearing impairments; E) Not using antidepressants within three months before and during the intervention.

Exclusion Criteria:

* Exclusion criteria included:

A) History of mixed psychiatric disorders, including schizophrenia, bipolar disorder, and dementia; B) Experiencing acute illness (or pain) and unstable physiological conditions; C) History of epilepsy or potential for seizures; D) Substance abuse; E) Participation in electroconvulsive therapy or transcranial electrical stimulation within one month before and during the intervention.
Iron Absorption From Tef-injera in Women of Reproductive Age

Anemia is one of the most common health problems all over the world with around half of preschool-aged children (\<5 years) and one third of women affected. Nutritional iron deficiency is a major reason for anemia in infants, young children and women of reproductive age who have especially high iron requirements that are difficult to meet in regions where the major diet is based on plant foods. So in Ethiopia, where injera is the major staple food. Despite high levels of iron in tef, the most favored cereal for injera, the iron bioavailability is assumed to be very low due to the high levels of phytic acid found in tef.

The aim of this study is to determine the iron bioavailability in women from injera prepared in a traditional way and investigate the potential of methods to improve the bioavaiability. Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be evaluated. Further the potential positive impact of phytic acid reduction on the iron bioavailability will be investigated. The phytic acid reduction will be achieved in two different ways, by addition of whole grain wheat as source of phytase and addition of a commercially available microbial phytase. The studies will be conducted in healthy women using stable isotope techniques.


Eligibility Criteria:
Inclusion Criteria:

* Reproductive age females 18-40 years
* Maximum body weight 65 kg
* Normal body mass index (18.5-25 kg/m2)
* No intake of mineral/vitamin supplements 2 weeks before and during the study
* No metabolic or gastrointestinal disorders or chronic diseases
* Not pregnant or lactating
* No regular intake of medication (except oral contraceptives)
* No blood donation or significant blood loss (accident, surgery) over the past 4 months
* Not currently participating in another clinical trial or having participated in another clinical trial during the last 3 months prior to the beginning of this study
* No former participation in a study involving administration of iron stable isotopes
* No eating disorders or food allergy
* Subject who can be expected and are willing to comply with study protocol
* Having received oral and written information about the aims and procedures of the study
* Having provided oral and written informed consent
Study on the Influencing Factors of Electroencephalogram Parameters Under Anesthesia

The depth of anaesthesia is affected by the age factor in the interpretation of EEG information. Only by fully considering the influence of the age factor can we accurately grasp the depth of anaesthesia.

In the process of general anesthesia, the reliable judgment of the depth of anesthesia has always been the focus of anesthesiologists.In recent decades, researchers have discovered that it is possible to monitor the effects of anesthesia using electroencephalography (EEG), so the information has come to be used to guide anesthesia management.The indicators derived from electroencephalogram (EEG) that can be used to judge the depth of anesthesia during general anesthesia, such as spectral edge frequency, burst inhibition rate, median power frequency, etc., were successively born. Thereafter, commercial instruments for monitoring the depth of anesthesia, such as EEG dual-frequency index, entropy module, Narcotrend index, etc., were also widely used in clinical practice.Although the anesthesia measurements or instrument has many advantages, but the use of these indicators are not considering the factors of age, and have been well documented for general anesthesia electroencephalography (eeg) of different ages is different, this means that in different age groups using the same monitoring indicators will lead to the judgment of anesthesia depth is larger error.Therefore, age should be considered in the process of monitoring the depth of clinical anesthesia, and appropriate indexes should be selected according to different ages to monitor the depth of anesthesia.However, it has not been thoroughly studied which indexes can be used to monitor the depth of anesthesia in each age group and how to conduct reasonable monitoring.Therefore, it is necessary to explore the monitoring indexes of depth of anesthesia in different age groups and the most appropriate monitoring program.

The purpose of this study was to validate EEG indicators that can monitor the depth of anesthesia at different ages, including basic EEG power spectrum parameters and processed parameters, and to explore whether there is an optimal protocol for monitoring the depth of anesthesia at different ages.In order to facilitate the clinical selection of patients of different age groups to monitor the depth of anesthesia, the factor of age is considered so as to take individual monitoring.Finally, it can accurately judge the depth of anesthesia and accurately use the anesthetic drugs.

Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ \~ Ⅲ level
2. 18 to 100 years
3. BMI 19 \~ 30 kg/m squared
4. Patients without intracranial surgery

Exclusion Criteria:

1. nervous system diseases, abnormal EEG, old cerebral infarction, the use of drugs affecting the nervous system;
2. coronary heart disease, hypertension without regular treatment or poor control;
3. The oxygen partial pressure and calcium ion levels were abnormal before anesthesia induction;
4. History of alcohol abuse.
Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women

This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron immediate release low dose or high dose tablets, compared to matched placebo, administered twice daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult female subjects 18 to 80 years of age, with a ≥ 6-month history of symptoms of overactive bladder including: frequency, urgency, and urgency urinary incontinence. Subjects must provide written informed consent and either be of non-childbearing potential or of childbearing potential meeting specific criteria (e.g., negative pregnancy test, sexual inactivity, acceptable methods of birth control, and use of hormonal contraceptives).

Exclusion Criteria:

* Subjects must have no history of pelvic or bladder disease, e.g., Grade 3/4 uterine prolapse, urogenital malignancy within the past 2 years, surgery for stress incontinence or pelvic prolapse repair within the past 6 months, or bladder injections with botulinum toxin at any time.
* Diabetes insipidus or poorly controlled Type 1 or Type 2 diabetes mellitus
* Cardiac conditions: prior cardiovascular events or procedures within 6 months of screening; congestive heart failure; abnormal ECG findings, including ECG QT correction interval (QTc) \> 470 msec at the Screening Visit; systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥100mmHg, or heart rate \> 100 beats per minute.
* Abnormal tests of liver function
* History of prior infection due to HIV or hepatitis B or hepatitis C virus
* Allergy or hypersensitivity to solabegron or mirabegron
* Women of childbearing potential: breastfeeding, pregnant, or actively trying to become pregnant
* Participation in a trial of an investigational or marketed drug ≤ 30 days prior to the Screening Visit or in any clinical trial of an investigational drug that may affect urinary function within 3 months prior to Screening Visit.
* Inability to read, understand, or complete study-related materials.