cyrilzakka/clinical-trials huggingface dataset:
Endoscopic Ultrasound (EUS) Guided Treatment With Humira for Crohn's Perianal Fistulas

This study is to assess whether utilizing endoscopic ultrasound(EUS) to guide treatment can improve durable fistula healing in patients with Crohn's perianal fistulas and to get preliminary information regarding the effectiveness of Adalimumab for Crohn's perianal fistulas.

Prospective randomized trial to assess the effectiveness of rectal EUS to guide perianal fistula treatment. Our hypothesis is that using imaging, in this case endoscopic ultrasound (EUS), to initially evaluate and then guide therapy with an anti-TNF agent (adalimumab) for fistulizing disease will lead to better short- and long-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

A patient may be considered for study participation if all of the following apply:

* Male and Female aged 18 years or older; and
* A confirmed diagnosis of Crohn's disease and one or more identifiable perianal fistulas.

Exclusion Criteria:

A patient will be excluded from the study if one or more of the following apply:

* Females who are pregnant or breast feeding;
* Infliximab received within 6 weeks prior to study entry;
* Patients who cannot take, or refuse to take concomitant immunosuppressive therapy with either azathioprine, 6-mercaptopurine, or methotrexate; Unless patient has been intolerant of these therapies in the past or is contraindicated as determined by the investigator;
* Patients who cannot take, or refuse to take concomitant antibiotic therapy;
* Patients with severe anal stenosis or tenderness which would preclude colonoscopy and / or rectal EUS;
* Patients who cannot take or refuse to take adalimumab;
* Patients with active or latent tuberculosis;
* Patients who have had systemic antibiotic, antiviral or antifungal treatment(s) within 3 weeks prior to Screening for all non-Crohn's related infections;
* Patients concurrently taking anakinra (Kineret);
* Patients with a history of cancer or lymphoproliferative disease other than a successfully and completely treated cutaneous squamous cell or basal cell carcinoma or carcinoma in-situ of the cervix;
* Patients with chronic hematologic problems such as bleeding dyscrasias;
* Patients with a history of demyelinating disease (i.e. multiple sclerosis); and
* Patients with congestive heart failure.
A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)

In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.

Approximately 960 participants will be entered in the study.

EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)

Approximately 960 participants will be entered in the study. Participants will be randomized 1:1:1 to receive low dose EYE103, high dose EYE103, or 0.5 mg ranibizumab, administered via intravitreal injection. In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm. Throughout the 2-year study, subjects will be evaluated every 4 weeks, including measurement of ETDRS BCVA, examination by slit-lamp biomicroscopy, fundoscopy, and SD-OCT. Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
* Be male or female ≥18 years of age.
* Have type 1 or type 2 diabetes mellitus and a HbA1c of ≤12%.
* Have a decrease in vision in the study eye determined by the investigator to be primarily the result of DME.

Exclusion Criteria:

* Be pregnant or breastfeeding
* History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
* Have any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy within 90 days of Screening
* Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
* If treatment-experienced for DME have a history of any of the following treatments within the noted time windows:

  * Have had prior treatment with 8 mg aflibercept (EYLEA HD) or faricimab (VABYSMO) within 120 days prior to the Screening visit in the study eye
  * Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept \[2 mg\], brolucizumab, pegaptanib sodium) in the study eye within 90 days of the Screening visit
Taiwan Severe Asthma Biologic Registry

This is a prospective multi-centers cohort study for registration adult patients with severe asthma and were reimbursed biologics treatment in Taiwan.

The goal of this observational study is to discover the real-world effectiveness, the impact of initiating, switching of biologics, and the possible prediction factors for selecting the best treatment option for patients.

The main question\[s\] it aims to answer are:

1. Determine risk factors associated with poor asthma control.
2. Support the development of effectiveness and safety of therapeutic principles
3. To discover the real-world effectiveness of different biologics ( Clinical remission)
4. To discover the impact of initiating biologics for severe asthma patients.
5. To evaluate the prevalence of biologics switching and its benefits for patients.
6. To compare the achievement rate of clinical remission among different biologics.

Participants who are treated either with omalizumab, mepolizumab, benralizumab dupilzumab or Tezepelumab after January 1, 2020 will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Patient should be reviewed as well as confirmed by the National Health Insurance Administration (NHIA) or by the study board member as a Severe Asthma case.
* Female and male aged over 18 years old.
* Patients who are treated either with omalizumab, mepolizumab, or benralizumab after January 1, 2020.

Exclusion Criteria:

* Lack of informed consent for participation.
* History of Biologic usage before January 1, 2020, should be ruled out.
* The washout period should be at least 12 months. In other words, the enrolled patients should have no experience in receiving a biological treatment or in participating relative clinical trial before his/her biologic initiation.
* Comorbid pulmonary diseases (e.g.: Chronic Obstructive Pulmonary Disease, Bronchiectasis, Pulmonary Fibrosis, etc.) or risk factors (e.g.: smoking or environmental exposure, etc..) that could be associated with pulmonary or systemic diseases, other than Asthma.
Phase 2 Study to Evaluation the Safety and Efficacy of Orally Administered KL7016 in Patients With Dry Eye Syndrome

This is a controlled study to determine the effectiveness and safety of KL7016 in the treatment of adult patients with dry eye syndrome (DES).


Eligibility Criteria:
Inclusion Criteria:

* Corneal staining score of ≥5 in either eye by the National Eye Institute/Industry Workshop guidelines
* Schirmer test score (without anesthesia) \< 7 mm/5 min in either eye
* Willing to use no topical ocular treatments, other than REFRESH TEARS® for the duration of the trial

Exclusion Criteria:

* Intraocular surgery within 3months
* Persistent intraocular inflammation or infection
* Corneal transplantation or neurotrophic keratitis
* Stevens-Johnson Syndrome
* Ocular herpes simplex virus infection
* Concomitant use of contact lenses or use within 3months
* Silicone lacrimal punctal occlusion or cauterization of the punctum within 3months
* Vision correction surgery without DES within 12months
* Unstable use of methotrexate or Disease-modifying drugs
Levosimendan In Patients Undergoing LVAD Implantation

According to the results from the literature, it has been shown that levosimendan usage 24-48 hours before LVAD implementation can improve short and long-term outcome in these patients regarding to the patients without preoperative pretreatment. The aim is to compare short and long-term outcome in patients who underwent to LVAD implementation and pretreated with levosimendan regarding the patient without pretreatment or with other medications.

Left ventricular assist device (LVAD) implantation is accepted for treatment of end-stage heart failure, in both as the bridging to heart transplantation or as the destination therapy. These patients have highly impaired systolic function which contributes to global heart dysfunction. The main complication is arising of pulmonary vascular pressures and pulmonary vascular resistance (PVR) and, consequently, right heart dysfunction. From the data in literature, RV dysfunction exist in approximately 25%-40% of patients with implanted LVAD, and in approximately 20%-30% of those died or have need for the RV assist device due to RV failure refractory to medications. Capability of the RV to maintain appropriate output and the fill of the LVAD is the main point for correct LVAD functioning and patients' early and late postoperative outcome. Preimplantation evaluation by echocardiography estimation of RV function, geometry and tricuspid valve function are the criteria for the diagnose of RV dysfunction. Laboratory analysis which can lead to the diagnose of RV dysfunction are also included in preimplantation evaluation. Specific inotropic therapy in patients with moderate or severe RV dysfunction and/or dilatation can improve RV function in preimplantation period. This is predominantly important in patients who were on the prolonged inotropic support with beta-agonist therapy before LVAD implantation and in whom their beta receptors are exhausted. The investigators will exam the hemodynamic effects of levosimendan administrated day before in patients underwent LVAD implantation. Further, investigators will analyze and evaluate early and late outcome in participants with implanted LVAD.

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for LVAD implantation

Exclusion Criteria:

* Known patient's allergy on medication
* Patient's disagreement for the procedure
Validity of the Turkish Version of "Perception of Quality in Anesthesia": A Prospective Observational Cohort Study

The aim of this study is to test the validity of the Perception of Quality in Anesthesia (PQA) and language compatibility.

The Perception of Quality in Anesthesia (PQA) scale was developed by Hocking et al. in 2013 to measure the quality of anesthesia service received by patients who underwent surgery under anesthesia. The survey consists of 16 questions. Researchers ask patients undergoing surgery to complete the PQA questionnaire 24 hours after surgery. The researcher visits patients in hospital rooms or makes phone calls the day after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective inguinal or umbilical hernia surgery under general or regional anesthesia
* Age between 18 and 80 years
* Ability to understand the content of surveys
* Native speaker of Turkish

Exclusion Criteria:

* Emergency operation
* The need for postoperative intensive care
* Existence of mental disability
* Pregnancy
Comparative Study Between Photodynamic Therapy With Urucum and LED and Probiotics in Halitosis Reduction

Introduction: Halitosis is a term that defines any foul odor emanating from the oral cavity. The origin may be local or systemic. The aim of the proposed project is to determine whether treatment with antimicrobial photodynamic therapy (aPDT) and treatment with probiotics are effective at eliminating halitosis. Methods and analysis: Fifty-two patients from 18 to 25 years old with a diagnosis of halitosis (H2S≥112 ppb determined by gas chromatography) will be randomly allocated to four groups (n=13) who will receive different treatments: Group 1 - treatment with teeth brushing, dental floss and tongue scraper; Group 2 - brushing, dental floss and aPDT; Group 3 - brushing, dental floss and probiotics; Group 4 - brushing, flossing, aPDT and probiotics. The results of the halimeter testing will be compared before, immediately after, seven days and thirty days after treatment. The microbiological analysis of the coated tongue will be performed at these same times. The quantitative analysis will be conducted using real-time PCRq. The normality of the data will be determined using the Shapiro-Wilk test. Data with normal distribution will be analyzed using analysis of variance (ANOVA). Non-parametric data will be analyzed using the Kruskal-Wallis test. The Wilcoxon test will be used to analyze the results of each treatment at the different evaluation periods. Ethics and dissemination: This study has been approved by the Ethics Committee of UNINOVE under process number 3.669.442. Results will be published in peer-reviewed journals and will be presented at national and international conferences.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 25 years;
* Sulphide (SH2) ≥ 112 ppb in the gas chromatography.

Exclusion Criteria:

* Dentofacial anomalies (such as cleft lip and cleft palate);
* Undergoing orthodontic and/or orthopedic treatment;
* Undergoing oncological treatment;
* Systemic alterations (gastrointestinal, renal, hepatic);
* Treatment with antibiotics up to 1 month before the survey;
* Pregnant.
* Individuals with fissured tongue
Clinical Study Assessment of SR-T100 Topical Gel Against Actinic Keratosis

To evaluate the efficacy of SR-T100 gel by observing the lesion size (length x width x height) of human cutaneous squamous cell carcinoma in situ (Actinic Keratosis and Bowen's Disease) reduced at least 75%.

An open phase II study to assess the efficacy and safety of topical SR-T100 gel in the treatment of human cutaneous cell carcinoma in situ (Actinic Keratosis and Bowen's Disease). The primary efficacy endpoint defines as the proportion of patients whose lesion size reduced at least 75%. The secondary efficacy endpoints include complete clearance rate as the proportion of patients with no clinical visible AK/BD lesions in the treatment area, partial clearance rate as the proportion of patients at least a 75% reduction of AK/BD lesion size in teh treatment area, and histological response rate as the proportion of patients with biopsy proven clearance of AK and BD in situ. Safety was evaluated by clinically significant changes occurring from baseline to the end of the study by observing physical examination, vital signs, laboratory assessments and AEs.

Eligibility Criteria:
Inclusion Criteria:

* Patients met ALL of the inclusion criteria for the entry of this study:

  1. Male or female; aged ≧ 20 years old.
  2. Patients had histologically confirmed Squamous cell carcinoma in situ (AK or BD) for the targeted lesion.
  3. Patients had a measurable lesion 5mm or larger for AK or 10mm or larger for BD.
  4. Patient had a performance status of \< 2 (ECOG).
  5. Patients who had signed an approved written informed consent.

Exclusion Criteria:

* Patients were excluded from this study for ANY of the following reasons:

  1. Patients with histologic subtypes other than squamous cell carcinoma in situ (AK or BD).
  2. Patients with tumor extending into the oral cavity, nostrils, eyelids, urethra, anus, vagina or rectum.
  3. Patients who had grossly suspicious or inflamed nodes on physical examination.
  4. Patients with grossly infected tumors.
  5. Patients with recurrent invasive squamous cell carcinoma.
  6. Patients with a history of other invasive malignancies, if there was any evidence of the other malignancy being present within the past 5 years. Patients were also excluded if their previous cancer treatment contraindicated this protocol therapy.
  7. Use of any investigational drug in the 30 days before screening.
  8. Pregnant or lactating women or women of childbearing potential using inadequate contraceptive methods.
Max Ivermectin- COVID 19 Study Versus Standard of Care Treatment for COVID 19 Cases. A Pilot Study

At present, there are no specific treatments for COVID-19. WHO recommends four treatments for COVID 19 with drugs i.eRemdesivir, Lopinavir/ ritonavir, Lopinavir/ ritonavir with interferon beta -1a, and chloroquine or hydroxychloroquine. Currently, there are several ongoing clinical trials evaluating potential treatments. Recently, LeonCaly reported that Ivermectin, an FDA-approved anti-parasitic previously shown to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), with a single addition to Vero-hSLAM cells 2 hours post infection with SARSCoV-2 able to effect about 5000-fold reduction in viral RNA at 48 h. Ivermectin therefore warrant further investigation for possible benefits in humans. The study rationale is to understand the effect of the drug on eradication of virus.

This study aims to confirm the antivirus effectiveness of Ivermectin on coronavirus i.e COVID 19 then to explore its potential use in the combating to the COVID 19 pandemics.

Enrollment of subject into the trial shall only occur after providing written permission to voluntarily participate into the study by signing and dating the informed consent form before starting any trial related treatment. 50 cases of COVID-19 will be enrolled into the trial. The trial shall be divided into two groups. First group with 25 confirmed cases of COVID 19 shall be treated with Ivermectin 200 to 400 mcg per kg body weight on day 1 and day 2 along with standard treatment of the hospital protocol. The second group with 25 confirmed cases of COVID 19 shall be treated with standard treatment as per hospital protocol for COVID 19. Subjects in both the arms shall be followed up for recovery of death with regular monitoring as per below schedule.

1. Test for virus at 1, 3 \& 5 days from beginning of trial drug started for the patient in the hospital
2. Clinical profile of the patient every day of hospitalization
3. Investigation of pulmonary function and oxygen saturation every day of hospitalization
4. The day a patient is put on ventilator and the day when removed
5. The day a patient develops acute respiratory distress syndrome and the day when relieved All the above data shall be collected on paper case record form for interim and final analysis from start of the trial i.e enrollment, treatment and follow-up. Viral test to monitor the eradication of Virus shall be done free of cost from third day of enrollment and providing the study drug on daily basis upto eradication of virus or completion of the trial

Eligibility Criteria:
Inclusion Criteria:

1. Subjects within age group between 18 to 75 years
2. With either sex, male or female
3. Confirmed case of COVID-19 at Max Hospitals.

Exclusion Criteria:

* Patients who are critically sick
Diagnostic Performance of Plasma Biomarkers of Alzheimer's Disease Compared With CSF Markers

.The goal of this interventional study is to estimate the diagnostic performance of plasma biomarkers of interest (Aβ40 and Aβ42, P-Tau and NFL), enabling discrimination between patients with and without a pathophysiological AD process. The main questions it aims to answer are:

* to define a threshold value for each of the plasma,
* to describe the correlations between the plasma biomarkers of interest and the other biological analyses performed as part of care, in particular triglyceridemia, cholesterolemia, glycemia and proteinemia,
* to describe biomarker results in relation to comorbidities, in particular dyslipidemia and diabetes
* to describe the final diagnosis and results obtained for plasma biomarkers, for patients with intermediate results according to the A/T/N classification (A-/T+ or A+/T-) Participants will be selected among patients undergoing lumbar puncture for the differential diagnosis of AD at Nancy University Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged 18 or over
* Person affiliated to a social security scheme or beneficiary of such a scheme
* Person who has received full information on the organization of the research and has signed an informed consent form
* Person whose care requires a lumbar puncture to measure markers of Alzheimer's disease

Exclusion Criteria:

* Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice)
* An adult unable to give consent
* Persons deprived of their liberty by judicial or administrative decision
* Persons under psychiatric care under articles L. 3212-1 and L. 3213-1.
* Pregnant, parturient or breast-feeding women
* Persons staying in a health or social establishment for purposes other than research.
Effects of Yoga on Cognitive and Immune Function in Colorectal Cancer

The purpose of this study is to determine if individuals with colorectal cancer enjoy yoga and to begin to assess whether yoga is effective in improving attention and immune function in individuals with colorectal cancer compared to physical activity and usual care.

The proposed study will use a prospective RCT pilot design with three arms (yoga, resistance and flexibility exercise, usual care) and a total of 60 men and women who have completed therapy (\> 6 months post primary or adjuvant therapy) to accomplish the specific aims. Equal numbers of men and women will be randomized into each arm of the study. Participants will be tested before, immediately after, and 3-months after treatment or similar time points for the usual care group. After data has been collected, participants who were randomized to the resistance and flexibility exercise group (active control group) or to the usual care group will be provided with the opportunity to participate in the yoga intervention.

Eligibility Criteria:
Inclusion Criteria:

* a history of any stage new or recuurent colorectal cancer
* great then 6 months post treatment for colorectal cancer
* report not fully recovered from the effects of cancer and cancer treatment
* no clinical signs or symptoms of brain metastasis
* normal (or corrected to normal) hearing and vision
* able to read and write English

Exclusion Criteria:

- conditions that could affect participation in yoga such as spinal disease or unstable joints