cyrilzakka/clinical-trials huggingface dataset:
Real-world Performance and Safety of Cerviron® in the Treatment of Vaginitis

Vaginitis is a broad term that includes a range of gynecological disorders characterized by infection of vaginal mucosa, inflammation of vulva and alteration of the normal vaginal microflora. The most prevalent is bacterial vaginosis, followed by other clinical entities such as candidiasis, trichomoniasis and non-specific vaginitis.

A collection of clinical data was conducted to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vaginitis in clinical practice. A total of 111 women aged between 20 and 70 years were recruited, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with antibiotic therapy. The aim of our study was to assess the relief in vaginal symptoms and changes in the normal vaginal pH level after 3 months of treatment with Cerviron® medical device in real-life clinical practice settings.

This study was designed as real-world evidence study with the primary purpose to assess the performance and tolerance of Cerviron® ovules in the treatment and management of various types of vulvovaginitis. The study collected clinical data from 28 different specialized gynecology clinical facilities. The study was conducted between May 20, 2021 and August 31, 2021.

The primary objective of this study was to assess the tolerability of Cerviron® ovules in the treatment and management of various types of vulvovaginitis, but also to confirm its performance both on symptoms relief and as a user-friendly device. The secondary objective of this study was to assess the performance of the medical device by clinical exam and patients' degree of satisfaction. The study design consisted of 3 or 4 visits over 90 ± 3 days. Cerviron® ovules were applied intravaginally, once per day, on the first day after menstruation and for 15 days during 3 consecutive months.

Data of 111 women aged between 20 and 70 years were analyzed, 71 of whom were treated with Cerviron® ovules as monotherapy and 40 who used Cerviron® ovules as supportive treatment in conjunction with anti-infectious therapy.

The symptoms recorded in the medical charts were followed to determine the performance of the medical device during the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adult females with a diagnosis of infectious or non-infectious vaginitis and treated with Cerviron® with or without anti-infectious treatment for at least three months:
* Negative result for Gardnerella vaginalis, Candida albicans, Trichomonas vaginalis.

Exclusion Criteria:

* Subjects with diagnosed abnormal genital bleeding;
* Subject with vulvar, vaginal or cervical cancer;
* Subjects with other inflammatory gynecological conditions.
The Jinling Cohort

The Jinling Cohort is a prospective, multicenter cohort study in which 15,000 eligible individuals aged 45-75 in Nanjing China will be enrolled.

Its aim is to assess the performance and clinical utility of the Multi-omics liquid biopsy MCED test MERCURY in an average risk Chinese population. Each participant will undergo peripheral blood collection for MERCURY test, health questionnaires and annual routine physical exams once a year for three consecutive years, then followed up two additional years. The entire assess time is 60 months.

The primary goals of the study is to evaluate sensitivity, specificity, positive/negative predictive value and other performance of MERCURY test.

The secondary goal of the study is (1) to evaluate how many cancer types the test MERCURY can detect and TOO accuracy; (2) With MCED test and routine physical exams being conducted in parallel for three years and following up for five years, the study allows to assess MERCURY test can detect cancer how many years earlier than conventional methods, leading to its clinical value evaluation of whether it can ensure reduction in late-stage cancer diagnosis; (3) to evaluate participants' attitude and perception towards MCED blood test.

Eligibility Criteria:
Inclusion Criteria:

1、45-75 years of age; 2、Willing and able to undergo blood sample collection, health questionnaires and annual routine physical exams once a year for three consecutive years; 3、Residents in Nanjing; 4、Fully understand the study and able to provide a written informed consent

Exclusion Criteria:

1. Pregnant women;
2. Individuals who have history of cancer or current diagnosis of cancer;
3. Individuals who have organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant;
4. Individulas who have blood transfusion within 30 days prior to the blood draw;
5. Individuals who have an acute infection or inflammation within 14 days prior to the blood draw;
6. Individuals who have taken medication with anti-tumor effects within 30 days prior to the blood draw;
7. Individuals who will not be able to comply with the protocol procedures judged by researchers
Impacts of Online and Group Perinatal Education

This project aims to evaluate the impacts of group prenatal education and online prenatal education on health determinants and users' health status.

Prenatal education is a core component of perinatal care and services provided by health institutions. Whereas group prenatal education is the most common educational model, some health institutions have opted to implement online prenatal education to address accessibility issues as well as the evolving needs of future parents. This prospective cohort study aims to evaluate the impacts of group prenatal education and online prenatal education on health determinants and the perinatal health status of parents. It is part of a larger multipronged study using mixed methods.

Eligibility Criteria:
Inclusion Criteria for pregnant women:

* 10-20 weeks of pregnancy
* Living within the targeted geographic territories
* Fluent in French
* Have not given birth previously

Inclusion criteria for partners:

* Partner of pregnant women between 10 and 20 weeks of pregnancy
* Living within the targeted geographic territories
* Fluent in French

Exclusion Criteria:

* Men and women not fulfilling inclusion criteria
Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between 18 and 45 years of age, inclusive
* BMI between 18 and 32 kg/m2 inclusive

Exclusion Criteria:

* Subjects with evidence of disease, conditions affecting drug absorption or metabolism
* Treatment with other investigational drug within 30 days
* History of regular alcohol or recreational drug consumption
* Use of prescription drugs within 14 days
* Use of nonprescription drugs and dietary supplement within 7 days
* Blood donation within 30 days
Ceramide Cream in Treating Women With Cutaneous Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of ceramide cream in treating women who have cutaneous breast cancer.

OBJECTIVES: I. Determine the objective response rate in women with cutaneous breast cancer treated with topical ceramide cream. II. Determine the time to progression in patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Assess the quality of life of these patients treated with this regimen.

OUTLINE: Topical ceramide cream is applied to all cutaneous lesions twice daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then at 1 and 3 months. Patients are followed every 3 months for 1 year and then every 6 months for 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed cutaneous breast cancer for which no curative or significantly palliative therapy exists including chest wall radiotherapy Measurable disease Disease progression after at least 1 hormonal therapy for estrogen receptor positive disease and after radiotherapy if chest wall disease has been previously irradiated No infection at site of cutaneous metastatic disease Hormone receptor status: Estrogen receptor status known

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-3 Life expectancy: At least 12 weeks Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy during first 2 months of study Chemotherapy: No other concurrent local antineoplastic therapy for cutaneous disease No concurrent systemic chemotherapy during first 2 months of study Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent radiotherapy during first 2 months of study except for CNS disease Surgery: Not specified
Calf Muscle Strength in Mitochondrial Diseases

Mitochondrial disorders are a group of inherited disorders causing malfunctional mitochondria. Mitochondria are found in every cell of the body, and the disorders therefore give symptoms from every tissue, especially those with high energy needs as the brain, heart and muscles. The disorders are highly disabling.

The aim of the study is to investigate the relation between muscle strength and contractile cross sectional area (CCSA) in the leg of patients affected by mitochondrial diseases. The hypothesis is that there can be a disrupted relationship between strength and CCSA.

Mitochondrial disorders are a group of inherited disorders caused by mutations in genes encoding mitochondrial proteins. The proteins are encoded by genes from both the mitochondrial DNA (mtDNA) and the nucleus, making some of the disorders maternally inherited and some autosomal recessive or dominant.

The mitochondria are found in almost all cells in the body and are the main source of energy. The energy is produced through the electron transport chain, which is composed of four multi subunit complexes (I to IV). A mutation in one or more of these complexes is a typical cause of a mitochondrial disease.

Since the mitochondria are found in almost every cell, mitochondrial disease can give rise to symptoms from many organs. The symptoms depend on what kind of mutation the patient has, but usually includes muscular and neurological problems, as these cells have especially high energy needs.

It is believed that the muscle weakness in mitochondrial diseases is caused by the reduced ability to produce energy. However, recent research has suggested that there is a structural change in the muscles as well. The hypothesis is that this structural change in the muscles will affect its function.

The aim of the study is to investigate the relation between muscle strength and contractile cross sectional area (CCSA) in the calf of patients affected by mitochondrial diseases. In healthy individuals there is a close relation between strength and CCSA, as the strength will decrease according to a decrease in CCSA. In mitochondrial disease, the hypothesis is that there can be a disrupted relationship between strength and CCSA.

The investigators will recruit 30 subjects with verified mitochondrial disease, and compare the results to that of healthy individuals (results from an earlier research project). A Dixon MRI will be used to find the CCSA of the calf muscle and a muscle dynamometer will be used to find the strength. These two variables are compared.

Eligibility Criteria:
Inclusion Criteria:

* Verified mitochondrial disease.
* Age: Over 18 years old

Exclusion Criteria:

* Contraindications for an MRI.
* Claustrophobia.
* Pregnant or nursing women.
* Competing disorders (as arthritis) or other muscle disorders.
Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation

The purpose of this study is to investigate the feasibility of a possible treatment regimen that could be used to delay tumor progression in patients with glioblastoma. The study is being conducted in patients who qualify for inpatient rehabilitation, as this population is particularly vulnerable to delays in initiation of chemoradiation and further tumor growth in the period between surgical resection and the start of treatment.

This is a pilot study to evaluate the feasibility and safety of early postsurgical temozolomide therapy prior to initiation of standard chemoradiation regimen in patients with glioblastoma who undergo inpatient rehabilitation. The study will be conducted with adult patients who qualify for inpatient rehabilitation following surgical resection of pathologically confirmed Grade IV glioma. Patients will begin a 21-day cycle of temozolomide starting 14 days after surgery at 75mg per square meter of body surface area daily to serve as bridge therapy. Patients will then progress to receive standard therapy following their rehabilitation stay. Patients will be assessed for their ability to complete the chemotherapy protocol without dose-limiting toxicity as well as complete inpatient rehabilitation successfully. Additionally, we will be assessing for tumor progression between the time of surgery and the time of treatment initiation.

If this study shows the expected results, the research team plans to proceed to a larger trial assessing the efficacy of early TMZ in patients with glioblastoma (GBM) who are admitted to acute inpatient rehabilitation compared to the current standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients, aged 18+
* Newly diagnosed World Health Organization (WHO) Grade IV glioma, confirmed on pathology
* Karnofsky Performance Score ≥ 60
* Subject has undergone biopsy, subtotal resection, or gross total resection of tumor
* Subject has been evaluated by physical therapy and thought to be a candidate for acute rehabilitation
* Subject must be accepted for admission on 5-1200 unit at Strong Memorial Hospital
* Subject must be able to provide informed consent
* Subject must meet the following laboratory parameters:

  * Absolute neutrophil count \> 1.5 x103/uL
  * Platelet count \> 140 x103/uL
  * Alanine transaminase \< 135 U/L
  * Aspartate transaminase \< 120 U/L

Exclusion Criteria:

* Subject has received previous treatment for high-grade glioma
* Subject has other active malignancy
* Subject is currently pregnant or breastfeeding
* Subject is a women of childbearing potential who is not using a reliable method of contraception
* Subject has history of hypersensitivity to temozolomide
Metformin Plus Paclitaxel for Metastatic or Recurrent Head and Neck Cancer

Metformin plus paclitaxel for recurrent or metastatic head and neck cancer: a randomized phase II trial

METTAX is a phase II randomized trial that aim to evaluate the addition of metformin to paclitaxel in patients that failed to curative-intent treatment for Head-and neck neoplasms.

Patients eligible for this protocol will be randomized to paclitaxel 175mg/m2 plus metformin or placebo until disease progression or unacceptable toxicity. The primary end-point is disease control (complete response, partial response or stable disease, according to RECIST 1.1) in the 12th week. Secondary end-points are PFS, OS, response rate and safety. Molecular markers in samples collected before and under treatment will be tested for correlation with clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Biopsy-proven head and neck squamous cell carcinoma
* Ineligibility for curative intent therapy, e.g., surgery or radiation therapy
* recurrent or stage IV disease
* previous failure to platinum-based chemotherapy
* measurable disease according to RECIST v1.1
* PS ECOG 0-2

Exclusion Criteria:

* known hypersensitivity to metformin or paclitaxel
* SNC metastasis
* Acute or chronic infection
Multi-Institutional Transgender & Gender-Diverse Breast Cancer Study

There is no granular retrospective data on breast cancer in transgender and gender-diverse (TGD) persons from a contemporary and diverse American cohort. The purpose of this investigation is to aggregate data from multiple institutions to describe the risk, diagnosis, management, and outcomes of TGD persons with breast cancer in effort to identify opportunities for future intervention studies to eliminate breast cancer disparities for this population.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years of age or older
2. Breast cancer diagnosis (including DCIS)
3. Persons who identify as gender and/or sex that is different from the sex they were assigned at birth

Exclusion Criteria:

1. Age \<18 at time of breast cancer diagnosis
2. Cis-gendered persons
Best Practice in the Management of Concha Bullosa in FESS Operation

Concha bullosa (CB) refers to the condition where the middle turbinate's interior is aerated (making the turbinate wide and thick). CB can narrow the middle meatus and the ostiomeatal complex. In adults suffering from chronic sinusitis, the prevalence of CB is approximately 34%. The most common treatment method for CB is turbinate crushing. This is considered a conservative treatment that preserves the mucous membranes relatively intact without opening the interior of the turbinate. Another fairly common method is the removal of the lateral part of the bullous middle turbinate. Opening the CB and removing the lateral part of the middle turbinate can lead to adhesions between the middle turbinate and the lateral wall of the nose. These adhesions can impede airflow and narrow or completely close the ostium or the surgically created middle meatal antrostomy. Crushing the CB is technically easier and possibly a less traumatic procedure. However, it is suspected that some of these crushed bullous turbinates may refill. The development of a mucocele is another potential issue. Crushing might be a better option compared to resection in the long term. Preserving the mucous membranes during crushing may reduce the formation of adhesions, which are sometimes seen after resection of the middle turbinate. The purpose of the study is to investigate the long-term benefits and side effects of CB treatment methods. The study will include 60 patients undergoing a basic Functional Endoscopic Sinus Surgery (FESS) procedure due to recurrent or chronic maxillary sinusitis. The patients will be randomized, with 31 undergoing resection and 31 undergoing crushing. Before the procedure, patients will undergo a CT scan (NSO-TT) and symptom evaluation through various questionnaires. All patients will also undergo nasoscopy.

One year after the procedure, the patients' conditions will be reassessed (questionnaires, nasoscopy, NSO-TT only if necessary), including the need for revision surgery.


Eligibility Criteria:
Inclusion Criteria:

* chronic or recurrent rhinosinusitis
* 3 months of regular nasal corticosteroid usage
* No prior endoscopic procedures of the paranasal sinuses
* EPOS criteria for CRS are met: inflammation of the paranasal sinuses with at least 2 symptoms, one of which must be nasal obstruction/congestion or nasal discharge (anterior/posterior):

  * facial pain/pressure in the facial area
  * reduced or lost sense of smell SNOT-22 25 or higher

    * Complications of CRS (e.g., mucocele)
    * Pregnancy/breastfeeding or plans for them in the near future
    * Coagulation disorders
    * Systemic diseases: cystic fibrosis, primary ciliary dysfunction, sarcoidosis, Wegener's granulomatosis
    * Immunosuppression: diagnosed SAD, CVI, HIV, or use of biological/immunosuppressive drugs
    * Immunotherapy
    * Daily use of systemic corticosteroids
    * Communication issues (non-Finnish-speaking patient, neurological/psychiatric problems)
    * SNOT-22 score \< 25
Efficacy of Hepatitis B Vaccine Boosters Among Neonatally Vaccinated Children in Chongqing

Worldwide, hepatitis B virus (HBV) infection is a major cause of acute hepatitis, and chronic infection with HBV often leads to chronic hepatitis, liver cirrhosis, and hepatocellular carcinoma. So far, the most effective way to prevent HBV infection in susceptible population is to inject hepatitis B vaccine. However, long-term protection against hepatitis B virus (HBV) after vaccination remains widely debated. This study aims to carry out a comprehensive study to evaluate the efficacy of hepatitis B vaccine booster from the aspect of humoral and cellular immunity in neonatally vaccinated children in Chongqing.

Hepatitis B virus (HBV) infection is a major public health problem around the world. More than 2 billion people have been infected with HBV. Although the World Health Organization (WHO) has incorporated hepatitis B vaccination into routine immunization programs for infants and adolescents since 1986 to reduce the incidence of chronic liver diseases, liver cirrhosis and hepatocellular carcinoma associated with hepatitis B virus, there are still more than 400 million chronic carriers. Although it is currently recognized that the most effective way to prevent HBV infection in susceptible population is to inject hepatitis B vaccine, the protective effect of the neonatally vaccinated children weakened as time goes on, which involves the question of the need of boosters. However, there are still some problems concerning hepatitis B vaccine boosters for healthy children. In China, there has not been a standardized directory to guide hepatitis B vaccine booster. Scholars have great controversy on the necessity, age, dosage and other aspects of hepatitis B vaccine booster. Researchers conducted an investigation on the Anti-HBs level of 93,326 Chinese children aged 1 - 16 who completed basic immunization. The results showed that the proportion of HBsAb positive in children aged 1 - 8 years old decreased dramatically, with 8 - year - old children having the lowest proportion of protective antibody. Therefore, this study is intended to explore the protective effect of hepatitis B vaccine on the body and the effect of multiple vaccines. This study will recruit some healthy children with anti-HBs at a low level (titer \<10mIU/mL and \[10,100) mIU/mL) in Chongqing and conduct selective re-vaccination according to the results of the first detection of hepatitis B surface markers in healthy children. According to the changes of immune status after booster, the efficacy of hepatitis B vaccine boosters was comprehensively evaluated.

Eligibility Criteria:
1. Born after Jan. 1st, 2005 in Chongqing, China;
2. Completion of the full primary immunization of HepB after birth;
3. No HBV booster vaccine history.