cyrilzakka/clinical-trials huggingface dataset:
Post Market Safety Study and Effectiveness With Evolence in Subjects With Skin Color Types IV-VI

Approximately 165 subjects with Fitzpatrick Skin Color Types IV, V, and VI and a moderate to deep wrinkle between the corner of the nose and the corner of the mouth, will be treated with EVOLENCE® (an approved collagen filler) to smooth and flatten that wrinkle. They will be observed for 6 months to establish safety of the product as it relates to scarring and changes in skin pigment, and long term effectiveness.

This is an open-label, multi-center, prospective, postmarket study to assess the safety and effectiveness of EVOLENCE® (DP101) in Subjects with Fitzpatrick Skin Color Types IV, V, and VI seeking correction of bilateral facial wrinkles and folds of the nasolabial area.

The study will enroll and treat a total of 165 subjects with Fitzpatrick Skin Color Types IV, V and VI who have clinical evidence of moderate to deep bilateral wrinkles in the nasolabial area.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* moderate to deep wrinkle in the Naso-Labial fold
* Fitzpatrick Skin Type IV, V or VI

Exclusion Criteria:

* Pregnant or nursing females
* Hx of allergies to related products
* history of keloids, active skin disease, or previous augmentation of the treatment area
Tislelizumab With Anlotinib and Chemotherapy for Second-line Treatment of Pancreatic Cancer

This is a prospective, one-arm, phase II clinical study of Tislelizumab Combined With Anlotinib and Chemotherapy for Second-line Treatment of Advanced or Metastatic Pancreatic Cancer

This is a single-arm, open-label, clinical trial of tislelizumab in combination with anlotinib and investigator-selected chemotherapy for second-line treatment of patients with advanced or metastatic pancreatic cancer. Patients with histopathologically or cytologically confirmed unresectable, recurrent or metastatic pancreatic cancer are planned to be recruited. Systemic medical antineoplastic therapy previously treated with first-line chemotherapy, meeting the inclusion and exclusion criteria of this study, and giving tislelizumab and anlotinib in combination with investigator 's choice of second-line chemotherapy regimen

Eligibility Criteria:
Inclusion Criteria:

* Advanced or metastatic pancreatic adenocarcinoma diagnosed by pathology;
* Previously received a standard first-line chemotherapy regimen of pancreatic cancer
* Age ≥ 18 and≤ 75 years old;
* Expected survival ≥ 3 months;
* ECOG score 0-1;
* Child-Pugh score \< 8;
* There is at least one measurable tumor lesion: the long diameter is ≥10 mm, and the short diameter of lymph nodes is ≥15 mm;
* The results of liver and kidney function and blood routine examination within 1 week before enrollment meet the following conditions:

Neutrophils (ANC) ≥ 1.5×109/L, platelets (PLT) ≥ 80×109/L, hemoglobin (HGB) ≥ 80g/L; Serum creatinine (Cr) ≤ 1.5 × upper limit of normal value; total bilirubin (TBIL) ≤ 2.5 × upper limit of normal value, Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤2.5× upper limit of normal value;

- The patient voluntarily participated in this study and signed the informed consent form.

Exclusion Criteria:

* Received other immunotherapy previously(including immune checkpoint inhibitor PD-1/PDL1 and other immune checkpoint inhibitors) and/or anti-angiogenic drugs (including anti-VEGFR monoclonal antibody and anti-angiogenic small molecule kinase inhibitors) ; Known to be severely allergic to the drugs used in the study of tislelizumab and anlotinib;
* Patients with obstructive jaundice who cannot reach TBIL ≤ 2.5 times the upper limit of normal value after surgical intervention;
* Patients with biliary obstruction that may occur or worsen within 4 to 6 weeks;
* Obvious blood coagulation disorder, active bleeding and bleeding tendency;
* There is a history of other malignant tumors within 5 years (adequately treated skin basal cell carcinoma, cervical in situ);
* Interstitial pneumonia or pulmonary fibrosis;
* Uncontrollable pleural effusion or ascites;
* Severe uncontrolled medical diseases, acute infections, recent history of myocardial infarction (within 3 months);
* During pregnancy or breastfeeding, and those who refuse to take appropriate contraceptive measures during the test;
* Patients judged by the investigator to be inappropriate to participate in this study.
A Prospective Cohort Study of Patients with Hepatobiliary Cancer Treated with Immune Checkpoint Inhibitors

Although immune checkpoint inhibitors including nivolumab and pembrolizumab are now available for the management of hepatobiliary cancers in Korea, there is a lack of data for the efficacy and safety of these agents in the real-world setting. This study aims to prospectively evaluate the efficacy of safety of nivolumab and pembrolizumab against advanced hepatocellular carcinoma and biliary tract cancer.

Nivolumab 3 mg/kg intravenous every 2 weeks has been recently approved by US FDA for the management of patients with sorafenib-failed advanced HCC based on the promising data of Checkmate-040 phase I/II study. Although there is a lack of prospective data for pembrolizumab in biliary tract cancer except for small phase 1 trial, pembrolizumab is now available for use in Korea for the management of advanced biliary tract cancer. Because the approval of these agents was based on the small sample size, further prospective evaluation of nivolumab or pembrolizumab in patients with hepatobiliary cancer is needed.

Eligibility Criteria:
Inclusion Criteria:

* Biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer) or hepatocellular carcinoma
* Planned immune checkpoint inhibitors including nivolumab or pembrolizumab
* Written informed consent

Exclusion Criteria:

* Not available for the treatment with immune checkpoint inhibitors
SGLT2 Inhibitors and Perioperative Period

The expanded use of SGLT2 inhibitors motivates us to assess the role of SGLT2 inhibitors in perioperative period on patients who will undergo cardiac surgery in Assiut University.

With over 50 million cases of heart failure worldwide, heart failure is one of the most serious health issues facing humanity. Heart failure patients still have an extremely poor prognosis and quality of life, even with advancements in heart failure treatment. It continues to be the most common cause of hospitalization in elderly.

A substantial number of theories have been proposed to explain the beneficial effects of SGLT2 inhibitors. These include blood pressure lowering, increasing diuresis/natriuresis, improving cardiac energy metabolism, preventing inflammation, weight loss, improving glucose control, inhibiting the sympathetic nervous system, preventing adverse cardiac remodeling, preventing ischemia/reperfusion injury, inhibiting the cardiac Na/H exchanger inhibiting SGLT1, reducing hyperuricemia, increasing autophagy and lysosomal degradation, decreasing epicardial fat mass, increasing erythropoietin (EPO) levels, increasing circulating provascular progenitor cells, decreasing oxidative stress; and improving vascular function.

In addition to lowering blood sugar, several large trials also have demonstrated cardiovascular and renal benefits in patients with T2DM. Surprisingly, recent data also suggest that SGLT-2 inhibitors may improve cardiovascular and renal outcomes in patients without diabetes, leading to expanded indications for their use.

Eligibility Criteria:
Inclusion Criteria:

1. All subjects with coronary artery disease or valvular heart disease referred to cardiac surgery

Exclusion Criteria:

1. Congenital heart disease.
2. Cardiomyopathy (EF\>40%).
3. Sever renal impairment (eGFR\>30).
4. COPD.
5. Marked obesity (BMI\<35).
6. Previous cardiac surgery.
Efficacy of Bifeprunox in Patients With Schizophrenia

The primary purpose of the study is to evaluate the efficacy of bifeprunox in the maintenance phase of schizophrenia compared to placebo.

Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. There are a number of antipsychotic drugs in use but none is ideal, in particular because their safety profile is complex and their effectiveness is limited. In particular, after having overcome acute exacerbations many patients continue to experience significant symptoms that prevent an adequate functioning. In the current study, patients suffering from schizophrenia and currently in a post-acute maintenance phase of the disease will be included. Non-treatment resistant patients will be included in the study, since they have partially responded to their current antipsychotic treatment but still have clinically significant symptoms and/or impairment of functioning in their daily life. The study is a 12-month study with an initial 12-week placebo-controlled, quetiapine-referenced phase. After this initial 12-week phase, the patients allocated to placebo will be switched to bifeprunox. In the final non-inferiority analysis of the 12-month data, the results from this study will be combined with the data from a similar study (11916A).

Eligibility Criteria:
Inclusion Criteria:

Main inclusion criteria

* The subject has a primary diagnosis of schizophrenia
* The subject experiences clinically significant symptoms
* The subject's medication remained stable for 8 weeks prior to screening
* The subject is currently in the post-acute maintenance phase of his/her disease

Exclusion Criteria:

Main exclusion criteria

* The subject is at significant risk of suicide
* The subject is treatment resistant
* The subject has experienced an acute exacerbation within 8 weeks prior screening
* The subject is unlikely to comply with the protocol
* The subject has a current diagnosis or a history of substance abuse
Effect of Intraperitoneal and Intravenous Lignocaine on Pain Relief Following Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and intravenous administration of lignocaine has been used. But it is not clear from the existing literature which form of administration is more effective for pain relief. Hence this study has been undertaken with the following hypothesis : Intravenous lignocaine is superior to intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response in laparoscopic cholecystectomy.

Laparoscopic Cholecystectomy is the treatment of choice for patients with symptomatic gall stones. For pain relief following laparoscopic cholecystectomy both intraperitoneal and intravenous administration of lignocaine has been used. But it is not clear from the existing literature which form of administration is more effective for pain relief. Hence this study has been undertaken with the following hypothesis : Intravenous lignocaine is superior to intraperitoneal lignocaine for postoperative pain relief and minimizing the stress response in laparoscopic cholecystectomy.

In this study the effect of intraperitoneal and intravenous lignocaine will be assessed based on the postoperative pain scores, total analgesic requirement, stress response in the form of total leukocyte count, c-reactive protein levels,return of bowel activity.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for elective laparoscopic cholecystectomy in the age group of 20 -60 years belonging to American society of anesthesiologists (ASA)score I-II

Exclusion Criteria:

* Chronic pain diseases other than gall stone disease.
* Use of opioids, steroids, Non steroidal anti inflammatory drugs or alcohol.
* Allergy and contraindication to Lignocaine.
* Conversion to open cholecystectomy.
* Patients who do not comprehend Visual analogue scale (VAS) / patient controlled analgesia (PCA).
Study of AT-101 in Combination With Topotecan in Relapsed/Refractory Small Cell Lung Cancer

This is an open label, multicenter Phase I/II study to evaluate the safety and efficacy of AT-101 in combination with topotecan in relapsed/refractory small cell lung cancer

Further Study Details provided by Ascenta:

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed small cell lung cancer (SCLC). Mixed histology will not be eligible.
* Progression of disease after only one prior platinum containing chemotherapy regimen. Prior Regimen must not have contained irinotecan
* All patients must have measurable disease.
* Patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities.
* ECOG performance status 0-1
* Adequate hematologic function
* Adequate liver and renal function
* Ability to swallow oral medication

Exclusion Criteria:

* Patients with more than one prior regimen of chemotherapy or prior regimen that did not contain a platinum agent. Note: Patient who stopped prior therapy due to toxicity or had less than 2 cycles of platinum based therapy would not be eligible for the phase II portion of this study.
* Prior chemotherapy regimen containing irinotecan.
* Active secondary malignancy.
* Unstable or progressive brain metastases.
* Prior history of radiation therapy to \> 25% of the bone marrow.
* Uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements.
* Failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).
Investigating Predictive Factors of Diabetes Occurence After Duodenalpancreatectomy

Regeneration of mature cells that produce functional insulin represents a major focus of current diabetes research aimed at restoring beta cell mass in patients with most forms of diabetes. The capacity to adapt in response to diverse physiological conditions during life and the consequent ability to cope for increased metabolic demands is a distinctive feature of the endocrine pancreas in the regulation of glucose homeostasis. Both beta and alpha cells are dynamically regulated to continually maintain a balance between proliferation, neogenesis, and apoptosis. In this proposal, the investigators will focus on exploring key mechanism(s) that potentially regulate islet cell plasticity in altered glucose metabolic states.

Investigators will explore in a unique cohort of individuals who undergo duodenal pancretectomy. Prior to their surgery will be performed in vivo studies (Hyperglycemic clamp, Euglycemic Hyperinsulinemic clamp and Mixed Meal Tests) to accurately assess glucose homeostasis parameters to classify each individual into metabolic phenotypes. Then exploit the opportunity to collect pancreas samples from these patients who will be evaluated again after surgery, the investigators will determine the ability of the remnant pancreas to compensate for the acute reduction in islet mass and perform correlations between ex vivo and in vivo parameters.

Specifically, the patients will be subjected to incretin secretion (mixed meal), metabolic status (OGTT), insulin secretion characteristics (first and second phase responses), β-cell insulin content evaluation (arginine bolus). Subsequently, pancreas samples will be evaluated for morphometry, and proteomics and gene expression analyses of islet cell samples obtain by laser capture will allow a detailed investigation of mechanisms that contribute to islet plasticity. The overall goal of this project is to investigate key mechanisms driving the ability of islet mass to adapt to diverse metabolic states. We aim to explore modifications in gene expression and proteomics and correlate them with specific metabolic phenotypes, in order to determine key regulators of islet morphology.


Eligibility Criteria:
Inclusion Criteria:

* SCHEDULED FOR PANCREATECTOMY
* NO DIABETIC and DIABETIC

Exclusion Criteria:

* CHRONIC DESEASES
* STEROID THERAPY
The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes

This study will investigate whether real-time continuous glucose monitoring can be used as a tool for behavior change in people with pre-diabetes.

The protocol is a prospective, non-blinded, randomized controlled study in persons with newly diagnosed pre-diabetes comparing the effects of real-time continuous glucose monitoring (RT-CGM) combined with diet and lifestyle education to those who have diet and lifestyle education alone. During a "wash-in" phase both groups will wear a masked CGM for 1 week at baseline and again after 12 weeks. Those randomized to the RT-CGM will wear it for 4 cycles of 2 week on/1 week off over the next 12 weeks. Both groups will follow-up with their primary care providers as clinically indicated over the next year with quarterly measurements of blood pressure, weight, and BMI. At the end of this period, they will wear a masked CGM for 1 week.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Newly diagnosed with pre-diabetes (within the previous 6 months) with a FPG of \> or = 110-125mg/dl or an A1c \> or = 6% - 6.4%
* Able to independently measure and read finger stick blood glucose levels
* Willing to wear the CGM device for up to 12 weeks during the study period
* Willing to test blood sugar by fingerstick twice per day while wearing the CGM
* DEERS eligible

Exclusion Criteria:

* Using medication for pre-diabetes
* Women who are pregnant, lactating, planning to become pregnant, or without a safe contraceptive method; all female subjects will undergo pregnancy testing via a serum HcG with their initial blood testing.
* Subjects who are taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study.
* Active Duty service members likely to be deployed during the 18-month study period.
Vasopressin and Methylprednisolone for In-Hospital Cardiac Arrest

This is an investigator-initiated, multicenter, randomized, placebo-controlled, parallel group, double-blind, superiority trial of vasopressin and methylprednisolone during adult in-hospital cardiac arrest. There will be ten enrolling sites in Denmark. 492 adult patients with in-hospital cardiac arrest receiving at least one dose of adrenaline will be enrolled. The primary outcome is return of spontaneous circulation and key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.


Eligibility Criteria:
Inclusion Criteria:

1. In-hospital cardiac arrest
2. Age ≥ 18 years
3. Received at least one dose of adrenaline during cardiopulmonary resuscitation

Exclusion Criteria:

1. Clearly documented "do-not-resuscitate" order prior to the cardiac arrest
2. Prior enrollment in the trial
3. Invasive mechanical circulatory support at the time of the cardiac arrest
4. Known or suspected pregnancy at the time of the cardiac arrest
A Study Comparing Two Formulations of Insulin Glargine in Healthy Participants

The study will aim to evaluate the following:

* Whether there are any differences in the way the body handles LY2963016 U-200 and LY2963016 U-100.
* How well-tolerated LY2963016 U-200 is compared with LY2963016 U-100.
* How LY2963016 U-200 affects the level of blood sugar in the body compared with LY2963016 U-100.

The study will last up to 17 weeks for each participant, including initial screening and follow up.


Eligibility Criteria:
Inclusion Criteria:

* Have a body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m²)
* Have a fasting plasma glucose less than (\<) 6.0 millimoles per liter (mmol/L) (108 milligram per deciliter \[mg/dL\])
* Have venous access sufficient to allow for blood sampling and clamp procedures per protocol

Exclusion Criteria:

* Have known allergies to the study drug, or any components of the formulation
* Have donated or had a blood loss of 450 milliliter (mL) within 3 months prior to study enrollment
Central Sensitization in Knee Osteoarthritis

The stimuli that activate nociceptors cause the dorsal horn of the spinal cord neurons to be sensitive to low-intensive afferent stimuli by decreasing the excitation threshold in patients with osteoarthritis. Although painful stimuli disappear, this situation causes pain to continue and a decrease in quality of life. Therefore, central sensitization should be considered and treated in patients with osteoarthritis. Although various pharmacological and electrophysiological agents are used in the treatment of central sensitization, adequate efficacy is not provided in patients with osteoarthritis. The aim of this study is to investigate the effects of balance exercises on central sensitization in patients with knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with primary knee osteoarthritis according to American College of Rheumatology criteria,
* To be stage 2-3-4 knee osteoarthritis according to Kellgren Lawrence radiological staging,
* To be with a central sensitization score of over 40 according to the CSI,
* To be able to fill the scales and accept to participate in the study.

Exclusion Criteria:

* Being diagnosed with secondary osteoarthritis or inflammatory rheumatic disease,
* Having cognitive impairment,
* To have been treated with physiotherapy, with an intra articular injection or with a surgery from the knee within a maximum of six months
* Having various diseases that may adversely affect performing balance exercises,
The Use of an Anterior Chamber Maintainer as a Sole Fluid Source in Micro Incision Cataract Surgery as Compared to a Standard Phacoemulsification Procedure

The purpose of this study is to compare the use of an Anterior Chamber Maintainer (ACM) as the sole fluid source in phacoemulsification micro incision cataract surgery (using 1.1mm corneal incision) as opposed to conventional coaxial phacoemulsification (using 2.4mm corneal incision).

Three-port Micro Incision Cataract Surgery (Tri-MICS) is a technique suggested by Professor Assia. The idea (principle) behind the Tri-MICS technique is the use of a sleeveless phaco needle which is introduced via a tiny incision (1.1mm). An additional corneal incision is made for the introduction of a second surgical instrument, and a third for an ACM as an exclusive source for the infusion - this saves the need for an additional instrument. The ACM that will be used in this study (AVI New York) is a small metal tube with an external diameter of 1.1 mm, and an internal diameter of 0.9 mm and was developed specifically for this use. This type of ACM has been used in hundreds of surgeries and has been found to be both effective and safe.

This procedure has 4 clear advantages:

1. The implementation of three corneal incisions, 1.1 mm wide with an angle of approximately 120 degrees between them - neutrality regarding astigmatism versus the Biaxial-MICS.
2. This procedure does not require any special medical instruments, for example; new phaco instruments which are specifically adapted for the MICS approach at the cost of tens of thousands of dollars.
3. This procedure allows a free use of the surgeon's second hand.
4. A fixed intraocular infusion keeps the intraocular pressure (IOP) and anterior chamber volume constant and stable.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral Cataract
* Ability to understand and sign on an inform consent form.
* whiling to undergo bilateral cataract surgery.

Exclusion Criteria:

* Mature Cataract
* PXF
* Uveitis
* Corneal Pathology
* Endothelial cell density\<1500 cells/mm
* Glaucoma
* Extreme Hyperopia / shallow anterior chamber
* Extreme Myopia
* s/p Ophthalmic Trauma / Surgery
* Allergy to Penicillin / IOD