cyrilzakka/clinical-trials huggingface dataset:
Open Non-Comparative Clinical Trial Study To Evaluate The Performance And Safety Of Ainara®

This study evaluates treatment with the medical device Ainara on the improvement of vaginal dryness evaluated by Vaginal Health Index (VHI) and Visual Analog Scale (VAS) in comparison with the baseline condition.

Detailed Description: This is an open, non-comparative, multicenter study that evaluates the performance and safety of the medical device Ainara.

In this study the investigators use polycarbophilic vaginal moisturizing gel (Ainara) for symptomatic treatment of vaginal dryness and monitor its impact on vaginal dryness symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women (total cessation of menses for ≥ 1 year) according to the STRAW criteria, aged ≥ 50 to ≤ 70 years;
* Diagnosis of vaginal dryness by:

  * Subjective dryness, any objective sign of VVA, pH\>5 as reported in the AGATA study
  * VHI \< 15.
* Body mass index (BMI) ≥ 18.5 to ≤ 36 kg/m2;
* Able to communicate adequately with the Investigator and to comply with the requirements for the entire study.

Capable of and freely willing to provide written informed consent prior to participating in the study.

Exclusion Criteria:

* Malignancy (also leukemic infiltrates) within 5 years prior to Day 0 (except for treated basal cell/squamous cell carcinoma of the skin).
* Genital bleeding.
* Estrogen vaginal treatment during the study period (it was permitted only if terminated at least 6 months before study).
* Systemic estrogen therapy (it was permitted only if terminated at least 6 months before study).
* Subjects with illness, or other medical condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the study or be likely to lead to hospitalization during the course of the study.
* Clinical evidence of acute infection currently requiring treatment (syphilis, herpes simplex, human papilloma virus, gonorrhea, chlamydia, lymphogranuloma venereum, etc.); clinical evidence or history of chronic infectious disease (i.e. tuberculosis).
* Psychosis, schizophrenia, mania, depressive disorders, history of suicide attempt or suicidal ideation, or any other psychiatric illness (except for intermittent anxiety).
* Known allergy to tested IMDs or its excipients.
* Drug or alcohol abuse in the 12 months prior to Day 0.
* Participation in an interventional clinical study or administration of any investigational agents in the previous 30 days.
* Presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study
High-intensity Focused Ultrasound Study

Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the structures in the proximity. Active surveillance carries the risk of disease progression and psychological distress to the patients. Focal therapy employs the concept of only destroying the significant lesion, resulting in disease cure and improved functional outcome. Among the different options of focal therapy, high-intensity focused ultrasound (HIFU) is one of the most commonly employed energy sources. It exerts its effect through thermal and mechanical destruction of cancer tissue. This study aims at assess the effectiveness of such treatment in prostate cancer management.

In this study, investigators evaluate the early oncological outcome and objective functional outcome of patients undergoing HIFU for the treatment of localized intermediate risk prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Visible index lesion(s) on MRI
* Index lesion(s) greater than 0.5 cm3
* Found to have localized low-risk or intermediate-risk prostate cancer after MRI-USG fusion targeted biopsy and saturation biopsy:

  1. Clinical tumour stage T2, or
  2. Gleason score 7, or
  3. PSA 20 ng/ml

Exclusion Criteria:

* Prostate size larger than 50 ml
* Patients unfit for contrast MRI exam
* Patients with previous treatment of prostate cancer
* Patients with previous surgery on the prostate
* Patients with active urinary tract infection
* Patients with bladder pathology including bladder stone and bladder cancer
* Patients with urethral stricture
* Patients with neurogenic bladder and/or sphincter abnormalities
* Fail to give informed consent
Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive

To investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.

In clinical institutions that enroll corona virus disease 2019 patients whose nucleic acids changed from negative to positive, two arms, multi-center, randomized and controlled methods are adopted. Patients are divided into two groups, favipiravir group and regular treatment group. 210 patients are expected to be enrolled and the cases are allocated according to the ratio of 2( favipiravir group): 1(regular treatment group).

Eligibility Criteria:
Inclusion Criteria:

1. COVID-19 has been diagnosed, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs has been negative for two consecutive times after treatment (sampling time interval of at least 24 hours);
2. The nucleic acid test of specimens such as sputum, throat swabs, blood, feces and other specimens was positive for COVID-19 during screening visits;
3. Voluntarily participate in research and sign informed consent.

Exclusion Criteria:

1. Those allergic to fapilavir;
2. Pregnant or lactating women;
3. Unstable liver, kidney, and heart diseases;
4. History of mental disorders, substance abuse or dependence;
5. Researchers consider it inappropriate to participate in research;
6. Participating in other clinical research.
Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study (V502-003)

This study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by the HPV types in the study vaccine, (2) To demonstrate that the vaccine is well-tolerated in women, (3) To evaluate vaccine immune responses in women.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Female, between the ages of 16 and 26

Exclusion Criteria:

* History of an abnormal PAP test or abnormal cervical biopsy result
* History of external genital/vaginal warts
* History of positive HPV test
* Currently a user of any illegal drugs or an alcohol abuser
* Are pregnant
* Currently enrolled in another clinical trial
* Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent).
PK/PD Comparison of Guanfacine ER and IR

Evaluate whether a 4mg/day or 6/mg day dose of extended-release guanfacine produces pharmacokinetic/dynamic (PK/PD) properties similar to 3mg/day immediate release guanfacine.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Able to read, write and comprehend English
* Smoker
* Able to take oral medications and willing to adhere to medication regimen
* Provide evidence of a stable living residence in the last 2 months, have reasonable transportation to the study site, and have no plans to move within the next 3 months or unresolved legal problems.

Exclusion Criteria:

* Any significant current medical conditions that would contraindicate smoking
* Current Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
* Positive test results at intake appointment on urine drug screens for illicit drugs
* Past 30 day use of psychoactive drugs including anxiolytics and antidepressants
* Women who are pregnant or nursing
* Suicidal, homicidal or evidence of current mental illness such as schizophrenia, bipolar disorder or major depression, or anxiety disorders
* Meeting DSM-IV criteria for current attention deficit hyperactivity disorder (ADHD)
* Individuals who are currently taking medications known to be effective for smoking cessation or are regular users of other tobacco products in the past 30 days
* Only one member per household can participate in the study
* Specific exclusions for administration of guanfacine not already specified include:

  * EKG evidence at baseline screening of any clinically significant conduction abnormalities or arrhythmias
  * Known intolerance for guanfacine or any alpha blocker
  * History of fainting, syncopal attacks
  * Heart failure or myocardial infarction
  * Impaired liver (as indicated by aspartate aminotransferase (AST), alanine aminotransferase (ALT) \>3x normal)
  * Renal function (as indicated by estimated creatinine clearance \<60cc/min)
  * Treatment with any antihypertensive drug or any alpha-adrenergic blocker
  * Use of any central nervous system depressant (e.g., phenothiazines, barbiturates, benzodiazepines)
  * Use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole) or inducers (e.g., rifampin), or consumption of grapefruit juice
* Subjects may have not donated blood in the past 8 weeks or have been involved in other investigational studies that involve substantial blood draws or medications unknown to us
Development of Children With DCD Before the Age of Six

The aim of this study is to map the early development of children with DCD and compare it to typically developing (TD) children.

At first we will investigate to what extent motor delay, reduced force, higher BMI, behavioral, ADL and participation problems occur in toddlerhood in DCD children and how this relates to TD children. We will also look into the evolution of these parameters in time (stability of development).

Secondly we will explore if the diagnosis of DCD can be predicted using a standardized test before the age of five.

A longitudinal study design enables us to assess children at three different ages (3y, 4y and 5y).

Assessment scores (AIMS or/and BSID) before the age of three will be retrieved retrospectively in the clinical group.

Eligibility Criteria:
Inclusion Criteria DCD group:

1. The multidisciplinary team of the Center of Developmental Disabilities reports that the child has DCD or is at-risk for developing DCD and this at the age of 2 and/or 3 years.
2. At least one parent speaks Dutch to the child

Inclusion Criteria controlgroup:

1. The child is three years of age at the moment of the first testing
2. Little-DCD-Q score ≥ 55 at 3y
3. M-ABC-2 percentilescore ≥25 at 3y
4. No medical diagnoses possibly influencing the motor development (DCD, ADHD, ASS, CP,...)
5. No history of developmental motor stimulation (therapy) and/or support
6. Gestational age ≥37w
7. Birthweight ≥2500g
8. At least one parent speaks Dutch to the child
Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas

The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-\[X\]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had surgery to treat anorectal fistula where the Biodesign® Fistula Plug was placed during the procedure

Exclusion Criteria:

* Patients not receiving the Biodesign® Fistula Plug for treatment of their anorectal fistula
Performance of FISH for the Diagnosis of Malignant Biliary Strictures in Thai Patients

Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators conducted a prospective study in 2 university hospitals to determine diagnostic performance of FISH for the diagnosis of malignant biliary strictures in Thai patients.

Fluorescence in situ hybridization (FISH) has improved the diagnostic performance of cytology for evaluation of malignant biliary strictures in the US and Europe. The utility of FISH for diagnosis of biliary strictures in Asia is currently unknown. The investigators aimed to compare the sensitivity of FISH and conventional cytology for the diagnosis of malignant biliary strictures in Thai patients. A prospective study was performed in 2 university hospitals between 2010 and 2013. Patients being evaluated for malignant-appearing biliary strictures were included. Bile duct brushings were collected and assessed by cytology and FISH. Sensitivities with 95% confidence intervals of cytology and FISH were main outcome measurements.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Clinical suspicion of malignant biliary tract strictures
A Study to Compare the Pharmacokinetics of CSL312 Administered by Prefilled Syringe Assembled to Autoinjector to the Pharmacokinetics Administered by Prefilled Syringe Assembled to Needle Safety Device in Healthy Subjects

This is an open-label, parallel-group, phase 1, single center study to assess the relative bioavailability of CSL312 administered subcutaneously via a prefilled syringe assembled to an autoinjector compared to a prefilled syringe assembled to a needle safety device in healthy, adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Male or female 18 to 55 years of age
* Body weight in the range of ≥ 50 kg and ≤ 100 kg, with a body mass index (BMI) of ≥ 18 kg/m2 and ≤ 30 kg/m2

Exclusion Criteria:

* Received any live viral or bacterial vaccinations within 8 weeks of Screening or is expected to receive any live virus or bacterial vaccinations during the study or up to 4 months after last administration of the investigational product.
* Evidence of current active infection, including severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2).
* Blood pressure or pulse rate measurements outside the normal range for the subject's age
Usage of Spirometry in Managing IgG Therapy in CVID with Airway Disease

Although there is evidence in the literature that gammaglobulin replacement therapy can lead to a reduction in the prevalence of pulmonary infection and improved lung function, there is no published study to guide immunologists regarding the use of spirometry in titrating IG therapy to assist in the management of immunodeficiency patients with regards to gammaglobulin replacement therapy.

The investigators propose to study the use of spirometry to identify patients that could potentially benefit from an increase in IGRT. The investigators will identify 22 common variable immune deficiency (CVID) study subjects on stable IGRT replacement therapy equivalent to 0.40 to 0.60 gm/kg per 4 weeks who have evidence of mild to moderate obstruction as assessed by an FEF25-75% between 50% and 80% of predicted. Patients who are on Hizentra will be preferentially recruited. Of these 22, 11 will be identified at random and treated for 6 months at their current dose (control population). The remaining 11 study subjects (treatment group) will have their level of IGRT increased by the equivalent of 0.05 gm/kg in dose per 4 weeks, adjusted for bioavailability as per manufacturer's instructions. On average, rounded up to the nearest gram, this will typically increase their dose of Hizentra by 2 gm per week.

The key finding of the published retrospective study was that common variable immune deficiency (CVID) patients with moderate, presumed reversible, obstruction on stable, therapeutic doses of IgG who exhibited a decline in lung function from one clinic visit to the next responded to an increased dose of IgG with an improvement in lung function as assessed by spirometry.

The investigators now wish perform a clinical trial to assess whether primary antibody deficiency patients receiving IGRT who fit in this range of obstruction, i.e. an FEF25-75% that is 50-80% of predicted, will demonstrate an increase in lung function, as assessed by spirometry, after increasing the dose of IGRT. The presumption is that obstruction at this level is most likely due to the effects of subclinical infections that can be reduced or avoided by increasing the amount of gammaglobulin received by the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet criteria for common variable immune deficiency (CVID) who are on stable IGRT for at least 3 months and who have an FEF25-75% between 50% and 80% of predicted.
2. Patients who are already on Hizentra will be preferred.

Exclusion Criteria:

1. Age \<21 or cannot perform spirometry.
2. Smokers with 20 pack years or more, and active smokers will not be included among the study subjects, but will be considered separately as an ancillary study.
3. Patients with specific antigen-specific antibody deficiencies or X-linked agammaglobulinemia on IGRT will not be included among the 20 study subjects, but will be considered separately in ancillary studies.
4. Patients with heart failure, TB, bronchiolitis, or lymphangioleiomyomatosis.
Using a Patient Navigator to Address the Social Drivers of Health in the Management of Pain

The purpose of this study is to see if patients with chronic pain can improve how they manage their pain and daily function by working with a care manager and by learning pain coping skills from an online teaching tool.

This study will determine the effects of patient navigator-delivered care coordination to address the major social drivers of health on pain-related outcomes. All participants will have access to web-based cognitive behavior therapy (PainTrainer) - a self-guided program that contains 8 modules, lasting 30-40 minutes each and can be completed in 8 to 12 weeks. Each module teaches behavioral coping strategies for pain management and recommends practice exercises. Some participants will also receive phone call visits with patient navigator to coordinate care.

Eligibility Criteria:
Inclusion Criteria:

* Patients with daily pain for 3 months or longer
* Chronic daily musculoskeletal pain with Pain, Enjoyment, General Activity (PEG) Survey score \>=4
* Primary care provider must be an Atrium provider
* Has at least one social driver of health: Financial insecurity, work and income, housing, food insecurity, safety, health literacy and at least one of the above, lack of social support and at least one of the above

Exclusion Criteria:

* Patients who have active cancer
* Cognitive impairment severe enough to preclude participation in a behavioral/lifestyle change program
* Live in a nursing home or inpatient treatment facility
* Unable to read and converse in English
* Those who are already connected to a patient navigator or nurse coordinator or social worker
* Planned elective surgery in the next 6 months
The Effect of Mobile Application Supported Diabetes Education On Type 2 Diabetes Self-Management And Blood Sugar Level

Diabetes is one of the biggest public health problems of the 21st century. Type 2 diabetes mellitus accounts for more than 90% of all diabetes cases and is the most common type of diabetes. Type 2 diabetes, in which genetic and environmental factors play a role,It is a metabolic disorder in which insulin resistance, decrease in insulin secretion and incretin hormone deficiency are effective in its physiopathology, characterized by polydipsia, polyphagia and polyuria, where the organism cannot adequately benefit from carbohydrates, fats and proteins due to insulin deficiency or defects in the effect of insulin, which requires continuous medical care.

Diabetes is a major cause of blindness, end-stage renal disease, coronary artery disease, stroke and inferior extremity amputations. These complications due to diabetes impair the patient's quality of life and impose social, financial and emotional burdens on both the patient and their family.

Diabetes education should be provided by healthcare professionals in order to ensure that diabetes patients knowledge and skills to prevent complications and provide better self management and self-care.

However, The fact that individuals do not have time to spare for face-to-face health education, the possibility of accessing information in the web environment repeatedly and the lower cost of education in the web environment compared to classical education increases the importance of web-based health education. The widespread use of mobile technologies in recent years has led to the development of new mobile applications related to diabetes.

The disquisition proposal the investigators prepared was created to investigate the effect of mobile application supported diabetes and nutrition education on type 2 diabetes self-management and blood sugar in newly diagnosed type 2 diabetes patients.

In this context, with the development of a mobile application prepared in visual, text and video format to provide diabetes education, the monitoring of blood parameters before and after diabetes education, and the implementation of the Type 2 Diabetes Self-Management Scale, (which consists of 19 items developed in 2020), and type 2 diabetes self-management and the effect on blood sugar will be examined. This study will provide answers to questions about the effectiveness of diabetes education given to Type 2 Diabetes patients via mobile applications on diabetes self-management and blood parameters.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed type 2 diabetes patients in the endocrinology and metabolism outpatient clinic of Ege University Medical Faculty Hospital.
* Patients with Type 2 DM, between the ages of 18-64, using smart phones and having regular internet will be included in the study.

Exclusion Criteria:

* Those who receive regular messages every day will be checked, and those who do not open/read more than 25% of the messages in total will be excluded.
* type 1 diabetes or gestational diabetes