cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety Evaluation of MONOBLUE DUAL View and MONOBLUE ILM View Vital Stains

In this study, the investigators aim to collect data regarding the efficiency and safety of two dyes used intraoperatively in vitrectomy to stain intraocular tissues. These products have the necessary approvals to use during such operation,These are NOT experimental products.

To determine efficacy and safety of MONOBLUE DUAL View and MONOBLUE ILM View (study products) vital stains during vitrectomy surgery.

Both study products are CE-marked and legally marketed in Europe. The data collection will serve as Post-Marketing Clinical Follow-up according MDR provisions. Retrospective data will also be collected for the two reference products: ILM Blue® (DORC) and Membrane Blue Dual® (DORC) to serve as control. For this purpose, patient data will be used that were collected in studies S61408 (Comparative study 23G vs 27G vitrectomy), S63610 (Comparative study 27G vitrectomy vs larger gauge surgery) and S64913 (EVA Nexus Field Observation Study).

The expected effect of the study products is to provide the retinal surgeon with adequate aid in visualizing the membranes involved in the retinal pathology to treat, thanks to their staining capabilities.

The performance of the study products is related to the visualization of retinal tissues (ILM and/or ERM) during the vitrectomy procedure, when these tissues cannot be distinguished accurately enough without staining. Their use allows for better identification of these tissues and facilitates their removal by the surgeon. The clinical benefit of using ophthalmic dyes is to increase the patient's ability to recover anatomically and functionally by allowing more precise surgery with an effective visualization tool.

Along with collecting post-marketing clinical follow-up data on the subject products, the outcomes of the present study results may be used at the UZLeuven Hospital to decide to use Monoblue ILM View and/or Monoblue Dual View as standard-of-care, replacing Membrane Blue Dual and ILM Blue.

Eligibility Criteria:
Inclusion Criteria:

Adult patients who underwent for vitrectomy surgery where ILM and/or ERM removal is required:

* Macular holes (ILM staining)
* Macular pucker (ILM and ERM staining)
* Vitreomacular traction (ILM staining)

Exclusion Criteria:

* Children aged \<18 years
* Vitrectomy for other indication than mentioned in 3.1
* Patients that have concomitant eye disease that may influence the outcome of the surgery, e.g. terminal glaucoma
* Patients that did to comply to the postoperative examination visit 6-10 weeks after the surgery
A Randomized Study to Compare the Efficacy and Safety of Belotecan and Topotecan as Monotherapy for Sensitive-Relapsed Small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy and safety of Belotecan administered 5 days every 3 weeks in comparison to Topotecan in Patients with relapsed small cell lung cancer.

A Phase Ⅱb, Randomized, Open, Parallel-Group, Multi-Center Trial to Assess the Efficacy and Safety of Belotecan(CamtoBell inj.) or Topotecan in Patients with Relapsed Small Cell Lung Cancer

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Histological or cytological diagnosis of SCLC
* Limited disease (LD) or Extensive disease (ED) at time of study entry
* Recurrent or progressive SCLC ≥ 90 days of duration of response for firstline therapy
* Measurable disease defined by RECIST criteria
* ECOG Performance Status of 0, 1, or 2
* Life expectancy ≥ 3 months
* Adequate bone marrow, Renal, Hepatic reserve:

absolute neutrophil (segmented and bands) count (ANC) ≥ 1500 cells/mm3 platelet count ≥ 100,000 cells/ mm3 hemoglobin ≥ 9 g/dL Total bilirubin ≤ 1.5 mm3 Alanine aminotransferase (ALT) and aspartate aminotransferase(AST) ≤ 2.0 X ULN Alkaline Phosphatase (ALP) ≤ 2.0 X ULN Serum creatinine ≤ 1.5mg/dL or calculated creatinine clearance \> 60mL/min

- Signed a written informed consent

Exclusion Criteria:

* Active infection
* Symptomatic brain lesion
* Any other type of cancer during the previous 5 years
* Severe concurrent diseases
* Prior anticancer therapy within 4 weeks before enroll
* Active pregnancy test and Pregnant or nursing women
* Participation in any investigational drug study within 28 days prior to study entry
Stablishment of Prevention and Treatment System for Intestinal Dysfunction

Dysfunction and intestinal endocrine dysfunction. This project will use genomics, metabonomics, microbiome and other omics techniques to study the clinical pathway of CID integrated therapy.


Eligibility Criteria:
Inclusion Criteria:

* The Patients with chronic bowel dysfunction

Exclusion Criteria:

* Past severe underlying diseases of the respiratory system and cardiovascular system,
* Allergy to treatment-related drugs,
* Pregnancy,
* Accept CID surgery.
Adult Subjects With Uncontrolled Type 2 Diabetes

A Multi-center, Double Blind, Randomized, Placebo-controlled, Parallel Group Phase IIa Study of MLR-1023 in Adult Subjects With Uncontrolled Type 2 Diabetes

Objectives

1. To assess the safety, tolerability and initial anti-diabetic activity of MLR-1023 in subjects with uncontrolled mild to moderate type 2 diabetes mellitus
2. To evaluate the pharmacokinetics of MLR-1023 and the major metabolite, MLR-1023-M1 following 28 days of repeat dosing

Design and Outcomes

The study is a randomized, double blind, placebo-controlled, parallel group study of MLR-1023 in adult subjects with uncontrolled type 2 diabetes mellitus who are on diet and exercise therapy.

A subset of subjects per dose group will have additional samples analyzed to measure signs of MLR-1023.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with uncontrolled T2DM who have received diet and exercise therapy for at least 3 months prior to screening, aged ≥ 18 - ≤ 75 years
2. Females must be post-menopausal, unable to conceive, or test negative for pregnancy via blood test and use barrier contraception
3. BMI ranging from ≥ 20 to ≤ 40 kg/m2
4. Fasting plasma glucose values of up to 240 mg/dL at screening, after wash-out (visit 2) and after placebo run-in (visit 3)
5. (i) naïve or (ii) currently using and discontinued metformin or (iii) no prior exposure to anti-diabetic agents other than metformin ≥ 6 months prior to screening

Exclusion Criteria:

1. History of Type 1 diabetes
2. History of more than 1 episode of severe hypoglycemia within 6 months prior to screening, or a current diagnosis of hypoglycemia unawareness.
3. Hospitalizations or Emergency room visits that would impact patient safety or data interpretation:

   1. Due to poor glucose control in the 6 months prior to screening or
   2. Any bariatric surgical procedures for weight loss.
4. Significant change of body weight (\>10%) in the 3 months before screening
5. Proliferative retinopathy or maculopathy within the 6 months before screening or requiring acute treatment, or severe neuropathy
Achieving Normal Glucose In Hospital Settings

The main objective of this study is to evaluate the efficacy and safety of 24 hours of closed-loop glucose control compared with standard diabetes treatment, in patients with type 2 diabetes treated by non-insulin glucose-lowering medications. This group is being studied as it is representative of patients with glucose dysregulation.

Algorithm driven closed-loop enables automated subcutaneous delivery of insulin in response to real-time continuous glucose sensor readings. Our studies to date have assessed the safety and efficacy of closed-loop insulin delivery in patients with type 1 diabetes in a controlled setting. For patients with type 2 diabetes treated by diet or non-insulin glucose-lowering medications alone, an episode of acute illness may result in elevated glucose levels necessitating initiation of insulin replacement therapy to optimise glycaemic control. Insulin may also be required in patients with no prior history of diabetes, presenting with 'stress hyperglycaemia'. Closed-loop systems may be of benefit in such insulin-naive patients in whom the optimal dosing regimen is difficult to establish, and may provide a safer method of insulin delivery with the added benefit of continuous monitoring of glucose levels on general hospital wards, thus minimising the likelihood of hyper- and hypoglycaemic events and their known associated worse outcomes.

The study has an open-label, randomised, two-period crossover design. Participants will be randomised to undergo two 24-hour studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm (intervention) or by patients' usual non-insulin glucose-lowering diabetes treatment regimen (control). A continuous glucose sensor will be inserted on arrival for each visit. Participants will consume regular meals (matched on both visits) and carry out daily activities mimicking those occurring in an inpatient setting. Stable glucose isotopes will be administered on the two study occasions to collect data for modeling of glucose turnover around meals and during the overnight period.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Type 2 diabetes for at least 1 year as defined by WHO
* Treatment with glucose-lowering medication(s) (including Exenatide) for at least 6 mths
* HbA1c between 7.0% and 10.0% inclusive (measured within past 3 mths)

Exclusion Criteria:

* Autoimmune type 1 diabetes
* Type 2 diabetes treated with insulin
* Type 2 diabetes treated with diet control alone
* Known or suspected allergy against insulin
* Proliferative retinopathy
* Current or planned pregnancy or breast feeding
* Any physical or psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by the study clinician
Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder

This study proposes to evaluate the effects of using a new floss holder (GumChuck) and the use of text messages during supportive periodontal therapy, on the psychological, behavioral and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework.

Despite evidence on the benefits of controlling dental biofilm for preventing gingivitis, patients have difficulty complying. Floss holder devices and SMS may be useful in enhancing both the frequency and effectiveness of dental hygiene behaviors, by increasing patients' motivation and self-regulation efforts, but scarce scientific literature supporting their worth in controlling gingivitis and the underlying psychological processes is currently available.

Eligibility Criteria:
Inclusion Criteria:

* Gingivitis BOMP \> 0.5
* 20 teeth (minimum 5 per quadrant)
* \> 18 years old

Exclusion Criteria:

* periodontitis (pockets \>3),
* smoking,
* orthodontics,
* pregnancy
* removable partial dentures
Tecemotide (L-BLP25) in Prostate Cancer

This study examines tecemotide (L-BLP25) in combination with standard treatment for prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologic documentation of prostate cancer confirmed at the institution of study enrollment prior to starting this study
* Newly diagnosed or previously untreated prostate cancer with intermediate or high risk features as defined in the protocol
* No evidence of metastatic disease on computed tomography (CT) / magnetic resonance imaging (MRI) or bone scans
* No systemic steroid use within 2 weeks prior to initiation of experimental therapy. Limited doses of systemic steroids to prevent intravenous contrast, allergic reaction or anaphylaxis (in subjects who have known contrast allergies) are allowed
* Eastern Co-operative Oncology Group (ECOG) performance status of 0-1
* Human leukocyte antigen (HLA)-A2 or A3 positive for immunologic monitoring
* Hematological and biochemical eligibility parameters as defined in the protocol
* No other active malignancies within the past 3 years (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder)
* Willing to travel to the study center(s) for follow-up visits
* Age greater than or equal to 18 years old
* Able to understand and sign informed consent
* Must agree to use effective birth control (such as a condom) or abstinence during and for a period of 4 months after the last administration of immunotherapy

Exclusion Criteria:

* No evidence of being immunocompromised by human immunodeficiency virus, a medical condition requiring systemic steroids, a medical condition requiring immunosuppressive therapy, splenectomy
* Active Hepatitis B or Hepatitis C
* Subjects should have no autoimmune diseases that have required treatment as specified in the protocol
* History of immunodeficiency diseases, hereditary or congenital immunodeficiencies
* Serious intercurrent medical illness
* A clinically significant cardiac disease
* Subjects who have received any prior therapy for prostate cancer
* Subjects who have known brain metastasis, or with a history of seizures, encephalitis, or multiple sclerosis
* Subjects receiving any other investigational agents
* Contraindication to biopsy such as bleeding disorders, ratio of prothrombin time to partial thromboplastin time (PT/PTT) \>=1.5 times the upper limit of normal, artificial heart valve
* Contraindication to MRI such as subjects weighing \>136 kilograms, allergy to magnetic resonance (MR) contrast agent, subjects with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices
* Contraindication to radiation therapy such as pre-existing and active prostatitis or proctitis, inflammatory bowel disease or known genetic sensitivity to ionizing radiation, or history of prior radiation to the pelvis
Clinical Trial Evaluating Low Dose G-FLIP Plus Mitomycin C for Stage IV Pancreatic Cancer

The study focuses on advanced metastatic pancreatic cancer, testing a combination of low-dose anti-cancer drugs (G-FLIP: Gemcitabine, Fluorouracil, Leucovorin, Irinotecan, and Oxaliplatin) with the addition of Mitomycin C. The aim is to find a safer and more effective therapy for this devastating disease.

Objective: Evaluate the safety, tolerability, and efficacy of G-FLIP combined with Mitomycin C for advanced pancreatic cancer.

Design: Open-label study with 60 evaluable subjects. Treatments: G-FLIP administered every 2 weeks, with Mitomycin administered every 4 weeks.

Efficacy Assessments: Based on response criteria (Complete Response, Partial Response, Stable Disease, Progressive Disease), Response Rate, Progression-Free-Survival, Overall Survival, and 12-Month Survival Rate.

Safety Assessments: Include physical exams, symptom evaluation, vital signs, ECOG performance status, clinical pathology, urinalysis, and Quality of Life assessments.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic (Stage IV) pancreatic adenocarcinoma.

  * Failed first-line chemotherapy.
  * ECOG performance status of 0-2.
  * Expected survival of more than 3 months.
  * Adequate organ function as indicated by lab values.
  * Age 18 or older.
  * Signed informed consent.

Exclusion Criteria:

* • Known brain metastases.

  * Significant cardiovascular or other uncontrolled diseases.
  * Pregnant or breastfeeding women
Study Comparing Quantitative Assessments in Open-angle Glaucoma (OAG) and/or Ocular Hypertension (OHT)

This study will evaluate assessments from the Goniometric Lens compared with those from anterior segment imaging in patients with open-angle glaucoma (OAG) and/or ocular hypertension (OHT).


Eligibility Criteria:
Inclusion Criteria:

* Open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* Allergy or sensitivity to diagnostic agents used in study
Prevalence of Chronic Oral Graft Versus Host Disease Risk Factors in Pediatric Patients

our aim is estimating the Prevalence and predicting risk factors for developing chronic oral graft versus host disease in pediatric patients subjected to hematopoietic stem cells transplantation

The study will be held in Children's Cancer Hospital Egypt for pediatric patients who underwent bone marrow transplantation.

this study describes oral conditions, detect possible oral pathological manifestations and evaluate their prevalence as well as correlating it to assumed risk factor as age, sex, type of the transplant , previous acute attack of graft versus host disease and other organ involvement . A standardized Transplant Database Questionnaire will be completed Clinical examination will be performed then findings will be recorded for oral mucosal lesions , salivary flow rate in milliliter , mouth opening in milliimeter.

Sample size estimation :

The aim of this study is to screen pediatric patients at least three months after they undergo allogeneic hematopoietic stem cells transplantation to detect any risk factors for developing oral manifestations of chronic graft versus host disease during this period. Every patient fulfilling inclusion criteria in the hospital will be recruited consecutively in a period of six months starting from April 2019.

Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients aged between 3 and 13 who underwent bone marrow transplantation at least 3 months ago.
2. Neoplastic or non- neoplastic diseases.
3. Patient receiving any protocol of GVHD prophylactic treatment.

Exclusion Criteria:

1. Patients who do not approve to join the study.
2. Patient receiving chemo or radiotherapy .
The Influence of Chinese Medicine on Metabolomics in Menopausal or Postpartum Women

Traditional Chinese herbal medicine, no matter mono-therapy or poly-pharmacy, is composed of complicated chemical constituents. Many confounding factors influence activity of Chinese herbs, including the origin of the herbs, safety of the products and consistency between batches. Study of the effectiveness and mechanism of Chinese herbs in vivo is much more challengeable due to unresolved problems of product quality control, screen of effective principles, monitor of the marker constituents and the targets for site of action. In this project, we will introduce the concept of metabolomics to detect total metabolites spectra as the biomarkers of Chinese herbs intervention. Correlation will be analyzed between changes in total metabolites and clinical improvements when menopausal women receive Suan Tsao Jen Tang or Jia Wey Shiau Yau San, and postpartum women receive生化湯.


Eligibility Criteria:
Inclusion Criteria:

* Insomnia according to PSQI\>6
* Informed consent
* Female
* Age 40-65 years

Exclusion Criteria:

* In 3 months before participating in and studying, happen great accident or heavy night shift or have time difference problems (such as the long-range flight) .
* Spiritual disease (melancholia,etc.) ,obstructive sleep apnea, heart disease history (the acute heart attack, cardiac arrhythmia) , hypertension , diabetes mellitus, cancer.
* Take melatonin or melatonin agonist, such medicines as acetylcholine, glutamate, serotonin, norepinephrine, GABA, histamine, adenosine, prostaglandins,etc..
Interleukin- 17 (IL-17), Bcl-3, and NF-kappa-B Inhibitor Zeta (IκBζ) Expression Levels in the Psoriasis Patients

This study aimed to compare the levels of IL-17 (interleukin- 17), Bcl-3 (B-cell lymphoma 3-encoded protein), and IκBζ (NF-kappa-B inhibitor zeta) in the gingival crevicular fluid of psoriatic and healthy individuals and the clinical parameters such as periodontal health, gingival index, plaque index and mobility (using periotest device)in the patient and control groups.

Patient selection

Ten patients previously diagnosed with psoriasis who visited the Van 100. Yıl University Faculty of Dentistry Oral and Maxillofacial Radiology dental clinic were included in the study. Non-psoriasis individuals were selected from volunteer patients attending the same dental clinic.

Clinical measurements

A periodontist conducted the periodontal evaluation, which included a comprehensive assessment of clinical periodontal status, a full mouth manual periodontal charting, measurement of probing depth, clinical attachment level, bleeding on probing, and evaluation of mobility using a periotest device. Additionally, information regarding the patient's smoking status, frequency of smoking, and oral hygiene habits was obtained.

Gingival crevicular fluid (GCF) collection

Samples were taken from two mandibular molar teeth. Before sampling, the sites were isolated with cotton rolls and then carefully dried with an air syringe to avoid saliva contamination. GCF was collected using sterile periodontal strips by gently inserting them into the gingival sulcus or pocket until slight resistance was noticed. After 30 s, the strips were collected into sterile tubes and immediately transported to the laboratory for storage (-40 °C) and posterior analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients previously diagnosed with psoriasis
* Adults who are 18 years of age or older
* Patients having at least 11 teeth

Exclusion Criteria:

* Patients with any known systemic disease other than psoriasis
* Patients who had received antibiotic, nonsteroidal anti-inflammatory, and/or immunomodulatory therapy within the last three months
* Patients who had received radiotherapy and/or chemotherapy within the last years
A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

BC106 is a molecule that when injected with insulin lispro may change the speed of absorption of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin lispro and any side effects that might be associated with it, blood levels of insulin lispro after injection under the skin and how BC106 insulin lispro affects blood sugar after injection under the skin. There is a minimum 7 day washout between single doses.


Eligibility Criteria:
Inclusion Criteria:

* Are not of child-bearing potential
* Have a body mass index (BMI) between 18 and 29.9 kilograms per square meter (kg/m\^2), inclusive
* Are nonsmokers or have not smoked for at least 6 months prior to entering the study
* Have a fasting plasma glucose less than 6.0 millimoles per liter (mmol/L) at screening

Exclusion Criteria:

* Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin including allergies to dextrans
* Have a history of first-degree relatives known to have diabetes mellitus
* Have used systemic glucocorticoids within 3 months prior to entry into the study
* Have donated or had a blood loss of 450 milliliters (mL) 3 months prior to study enrollment
Gene Biobank of Sports Injuries

Preserve biological samples and gene extracts of all sports medicine-related diseases. To study related gene mutation sites and regulation. To study related molecular mechanisms and signaling pathways. A storage platform for sports medicine-related diseases research sample database has been established.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with joint sports injuries.
2. Follow-up patients after sports injury.
3. Patients with genetic predisposition to sports injuries.
4. Patients with family genetic predisposition to exercise-related diseases and their relatives.

Exclusion Criteria:

1. Patients with joint damage caused by external force.
2. The patient is accompanied by other injuries at the same time.
Clinical Trial To Evaluate The Effect Of Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance

THE PURPOSE OF THIS STUDY IS TO DETERMINE IF 24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG) IMPROVES INSULIN SENSITIVITY IN SUBJECTS WITH HIGHER THAN NORMAL GLUCOSE LEVELS USING A TEST CALLED THE EUGLYCEMIC CLAMP.


Eligibility Criteria:
Inclusion Criteria:

history or presenting hypertension Elevated fasting blood glucose levels -

Exclusion Criteria:

Pregnancy potential Diabetes mellitus

Other criteria apply

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