cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Biphasic Insulin Aspart 30 Treatment Regimens in Subjects With Type 2 Diabetes Not Achieving HbA1c Treatment Targets on OADs Alone

This trial is conducted in Asia. The aim of this trial is to compare the glycaemic control when subjects initiate a biphasic insulin aspart 30 treatment followed by an intensified treatment if treatment target of HbA1c below 7% is not reached by OAD (oral anti-diabetic drugs) alone.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes for a minimum of 6 months prior to Visit 1
* HbA1c at least 7.0 % - maximum 11 % at screening
* Subject is insulin naïve (short-term insulin treatment of up to 14 days is allowed)
* An antidiabetic regimen that has been stable for at least 3 months prior to screening
* An antidiabetic regimen that includes a minimum of 2 OADs
* OADs dosed at least 50% of the maximum recommended dose

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product(s) or related products
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
* The receipt of any investigational medicinal product within one month prior to this trial
* Suffer from a life threatening disease (cancer)
* Cardiac disease: class III or IV congestive heart failure (CHF), unstable angina, and or any myocardial infarction (treated or untreated) within 6 months prior to screening
* Hepatic insufficiency (Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 2 times the central laboratory's upper reference limit)
* Renal insufficiency (serum creatinine above 1.6 mg/dl for males; 1.4 mg/dl for females
* Recurrent hypoglycaemia or hypoglycaemic unawareness
* Anemia (haemoglobin below 10 mg/dl)
Effect of Orange Aroma on Nausea, Vomiting and Anxiety During Autologous Stem Cell Transplantation

Patients undergoing stem cell transplantation for the first time will be entered. Participants will be randomized to one of two study arms: Arm 1: intervention (routine care+ inhalation aromatherapy); Arm 2: Control (Routine care) Hypotheses: (1) Patients receiving inhalation aromatherapy will experience less severe nausea and less frequent vomiting episodes than those receiving only routine care; and (2) patients receiving inhalation aromatherapy will demonstrate lower anxiety levels just after AHSCT than those receiving only routine care.

Earlier research indicates that aromatherapy is promising to relieve in DMSO related nausea and anxiety in autologous stem cell transplant patients. The current study seeks to confirm and extend these findings in a 2-arm, open-label randomized, controlled study of 70 cancer patients undergoing autologous stem cell transplantation. All patients will receive a standardized premedication. Arm 1: Intervention (inhalation aromatherapy with orange essential oil during stem cell infusion); Arm 2: Control (routine care). The researchers hypothesize that inhalation aromatherapy with orange essential oil will be effective in reducing DMSO related nausea and vomiting and demonstrate lower anxiety levels just after autologous stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years,
* the absence of any mental conditions including depression, anxiety disorders, psychotic disorders or dementia that may affect the patients' communication abilities

Exclusion Criteria:

* Patients with chronic obstructive pulmonary disease or asthma,
* a history of allergy to orange or orange essential oil,
* presence of persistent nausea and vomiting due to conditioning regimens,
* receiving antiemetic other than routine premedication,
* patients undergoing AHSCT for the second or more time were excluded
SAFEty of Two Strategies of ICD Management at Implantation

The aim of this prospective observational study is to evaluate the safety, over a follow-up of 2 years, of two strategies, consisting in performing or not performing defibrillation testing(DT) during first implant of implantable cardioverter defibrillator

The standardized requirements for implantable cardioverter defibrillator (ICD) include defibrillation testing (DT), consisting in induction and termination of ventricular fibrillation (VF). An effective DT has historically been considered part of standard procedures at implant. Nevertheless, implant techniques and technology have evolved during years and nowadays deviations are frequent in clinical practice mainly due to the fact that physicians are seriously concerned about the risk of severe complications related to DT. However, the practice of not performing DT is arbitrary and its safety is yet unproven. This observational study will assess the safety of the two strategies adopted at ICD implant: induction (including patients who undergo DT at implant) and non-induction (including patients who do not undergo DT at implant. No deviation from the centres' current practice in choosing to perform or not perform DT is introduced by this study protocol. The study considers consecutive patients undergoing first implant of ICD

Eligibility Criteria:
Inclusion Criteria:

* first implantation of ICD or CRT-D
* Patients undergoing upgrade to ICD or CRT-D from pacemaker
* Patients undergoing upgrade to CRT-D from CRT
* Age 18 or above, or legal age to give written informed consent

Exclusion Criteria:

* Patients who do not give consent to treat their data.
Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma

The purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced oral squamous cell carcinoma.

The purpose of this study is to investigate the safety and feasibility of neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy in subjects with resectable local advanced OSCC. And on this basis, we will explore the changes of the profiles and functions of immune cells within tumors, lymph nodes and peripheral blood after the experimental interventions, as well as their correlation with the patients' response and prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically documented oral squamous cell carcinoma (biopsy required).
2. Local advanced oral squamous cell carcinoma (clinical stage T1-2N1-3M0, T3-4aN0-3M0) with resection option for potential cure, as assessed by a faculty surgeon at Hospital of Stomatology, Wuhan University.
3. Distant metastasis is excluded by chest CT and emission computed tomograph.
4. Adequate organ function as follows: 1) Leukocyte count ≥ 2,000/mm3; 2) Absolute neutrophil count ≥ 1,000/mm3; 3) Platelet count ≥ 100,000/mm3; 4) Hemoglobin ≥ 90 g/L; 5) Serum albumin ≥30 g/L; 6) Total bilirubin ≤ 1.5 × upper limit of normal (ULN); 7) AST (SGOT) and ALT (SGPT) \< 2.5 × ULN; 8) ALP ≤ 2.5 × ULN; 9) Prothrombin time-international normalized ratio ≤ 1.5; 10) Serum creatinine ≤ 1.5 × ULN; 11) INR/PT≤ 1.5; 12) TSH ≤ ULN.
5. ECOG performance status 0-1.
6. Female patient tested HCG negative in serum or urine within 7 days prior to the start of investigational product. Both patient and partner must agree to use contraception prior to study entry and for the duration of study participation and for up to 120 days after the last dose of PD-1 blockade.
7. Patient understands the study regimen, its requirements, risks and discomforts and is able and willing to sign the informed consent form.

Exclusion Criteria:

1. History of ≥ 3 grade immune related adverse events (irAEs) or have not recovered to ≤ 1 grade irAEs from previous treatment.
2. History of other treatments for cancer, including surgery, chemotherapy, radiotherapy or molecular targeted therapy within past 5 years.
3. Previous therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody targeting T cell co-regulatory pathways.
4. Active autoimmune disease or history of refractory autoimmune disease.
5. Active systemic infection requiring therapy.
6. Patients who are receiving psychotropic drug or alcohol/drug abuse.
7. Subjects with concurrent other active malignancies.
8. HIV or untreated active HBV or HCV infections, or vaccinated (HBV, flu, varicella, etc) within 4 weeks before recruitment.
9. Uncontrollable systemic diseases, including diabetes, hypertension, etc.
10. History of stroke or transient ischemic attack within past 6 months.
The Effects of Butyrate on Children With Obesity

Butyrate is a short chain fatty acid (SCFA) produced by bacterial fermentation of undigested starch in the gut. Butyrate carries out different effects at intestinal and extraintestinal level, including: immune regulation with anti-inflammatory effect at intestinal and systemic level and modulation of gut microbiota. Many of these effects result from an epigenetic mechanism. Shown in an animal model of obesity induced by a high fat diet (HFD), that butyrate can exercise very effective protective action against obesity through the stimulation of intestinal satiety hormones. Shown always in murine model of obesity induced by HFD, that butyrate is effective in preventing and treating obesity and insulin resistance. After 5 weeks of treatment with butyrate was observed a reduction of 10.2% of body weight, 30% of fasting glucose and 50% insulin resistance.

In an animal model of metabolic syndrome with NAFLD researchers have recently demonstrated that the administration of butyrate is able to significantly reduce insulin resistance, liver damage, dyslipidaemia through a modulation of the inflammatory process.

Pharmacokinetic and pharmacodynamic studies in humans show that the oral administration of butyrate is safe and well tolerated. The peak serum levels occurs 4-6 hours after oral administration.

All of these data makes plausible a possible positive effect on insulin resistance in the obese child.


Eligibility Criteria:
Inclusion Criteria:

* Obesity (BMI \>95° percentile)
* HOmeostasis Model Assessment (HOMA-IR) \> 4 (obtained by calculating the product of fasting plasma insulin expressed in microunits/mL and fasting plasma glucose expressed in mmol/L divided by 22.5)

Exclusion Criteria:

* Age \<10 or \>15 years
* BMI \<95° centile
* HOMA-IR \<4
* Patients under pharmacological treatment for obesity (metformin) or taking vitamin E, pre-, pro- or synbiotics
* Simultaneous presence of other chronic diseases unrelated to obesity (cancer, immunodeficiency, cystic fibrosis, allergies, celiac disease, autoimmune diseases, neuropsychiatric disorders, type 1 diabetes, inflammatory bowel diseases, malformations of urinary or gastrointestinal or respiratory tract, chronic lung diseases, genetic and metabolic diseases, chronic hematological diseases)
* History of surgery for the treatment of obesity
* Any medical condition that may interfere with participation in this study
* Participation in other clinical trials still in progress
Assessing the Impact of Acupuncture Therapy on Medical Resident Well-Being: Feasibility and Acceptance

This feasibility study develops methods for larger-scale research, evaluating the acceptability and perceived impact of a group acupuncture and acupressure intervention, as well as suitability of a self-report instrument. During their weekly training program, eleven OB residents at NYU Lutheran Medical Center will receive three sessions of auricular acupuncture therapy. (This resident population was previously anonymously surveyed and all expressed interest in participating in such a study). The Professional Quality of Life Scale (ProQOL) will be administered at 6 time points. A brief survey will also be given to assess participants' acceptance of the intervention as well as applicability of the ProQOL instrument. Additional feasibility-related outcomes include protocol compliance/withdrawals, adverse events, and time taken to complete intervention and surveys.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in NYU Lutheran Obstetrics \& Gynecology Residency program

Exclusion Criteria:

* Women currently pregnant or attempting to conceive
Special Drug Use Investigation of EYLEA for Diabetic Macular Edema

The objectives of this study are to investigate the safety and effectiveness of EYLEA

This is a prospective, non-interventional, multi center post-authorization safety study that includes patients with a diagnosis of myopic choroidal neovascularization. The investigator will have made the choice of treatment (EYLEA) as well as the decision to use EYLEA according the Japanese Package Insert prior to enrolling the patient in this study.

The observation period for each patient starts when therapy with EYLEA is initiated. The enrollment period is 2 years. Patients will be followed for a time period of 2 years or until it is no longer possible (e.g. lost to follow-up) within the 2 years. In total, 600 patients will be recruited.

For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visits and final visit, either by routine clinical visits (as per investigators routine practice).

Eligibility Criteria:
Inclusion Criteria:

* Patients who start EYLEA treatment for Diabetic Macular Edema (DME)

Exclusion Criteria:

* Patients who have already received EYLEA treatment
PRESSUREwire Study

The purpose of this study is to understand routine use of FFR (Fractional Flow Reserve) and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

The purpose of this study is to understand routine use of FFR and alternate indices in clinical practice. This study will determine the use and clinical outcome of FFR-guided PCI in patients presenting with either stable coronary artery disease, or in patients presenting with Acute Coronary Syndrome (ACS) on culprit and non-culprit lesions as well as during index and secondary procedures.

The study will also collect data on the routine use of coronary physiologic measurements such as adenosine-induced hyperemia FFR, FFR by contrast-induced hyperemia,

Eligibility Criteria:
Inclusion Criteria:

* Patient is presenting with STEMI, NSTEMI, unstable angina, or stable coronary artery disease
* Patient is planned to have FFR performed or underwent a cardiac catheterization where FFR was performed for further PCI (Percutaneous Cardiac Intervention) consideration
* Patient signs and dates written informed consent
* Patient is eighteen years of age or older at the time of consent

Exclusion Criteria:

* Patient has extremely tortuous or calcified coronary arteries
* Patient with a patent coronary artery bypass graft to the target vessel
A Study of LY4064809 [14C]-STX-478 in Healthy Male Participants

The main purpose of this study is to conduct blood tests to measure how much STX-478 is in the bloodstream and how the body handles and eliminates it in healthy participants. This study will involve a single dose of 14C radiolabeled STX-478. This means that a radioactive tracer substance, C14, will be incorporated into the study drug STX-478 to investigate the study drug and its breakdown products and to find out how much of these passes from blood into urine, feces and expired air. The study will also evaluate the safety and tolerability of STX-478.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at Screening; body weight

  ≥ 55.0 kg and ≤ 100.0 kg at Screening.
* Negative serology results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) and human immunodeficiency virus antibody and antigen (HIV Ab/Ag).
* Non-smoker (with no use of other tobacco or nicotine containing products, in any form), as documented by history (no nicotine within 6 months prior to Screening) and a negative cotinine test at Screening and admission

Exclusion Criteria:

History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor

* Any history of serious allergic/hypersensitivity reactions
* History or presence of alcohol or drug abuse (self-reported) within 2 years prior to Screening.
* Administration of any prescription or non-prescription drugs (including antacids; however, acetaminophen at a dose ≤ 1 g/day is permitted), herbal remedies or vitamin supplements from 28 days, or five half-lives, whichever is longer, prior to Admission.
Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes

This is a double-blind, randomized , placebo-controlled study to evaluate the safety and tolerability of AVT001, and to assess AVT001 as a potential treatment for type 1 diabetes (T1D). The trial will involve approximately 24 new-onset T1D subjects.


Eligibility Criteria:
Key Inclusion Criteria:

1. Diagnosis of type 1 diabetes, within 12 months of first dosing, confirmed by positive lab result for one or more of the following types of autoantibodies:

   1. Glutamic acid decarboxylase (GAD65)
   2. Insulinoma associated protein 2 (IA-2, also known as ICA-512)
   3. Zinc transporter 8 (ZnT8).
2. Age 16 or older and able to provide informed consent/assent.
3. If a participant is female with reproductive potential, willing to avoid pregnancy through the duration of the trial.
4. Signed and dated written informed consent/assent.

Key Exclusion Criteria:

1. Poorly controlled diabetes despite insulin therapy, who in the opinion of the investigator would not be a good candidate for participation in a clinical trial
2. Screening hemoglobin \<10.0 g/dL; leukocytes \<3,000/uL; neutrophils \<1,500/uL; lymphocytes \<800/uL; platelets \<100,000/uL
3. Screening Urine Albumin Excretion \> 300mg/gmCr
4. Screening eGFR \< 60 mL/min/1.73m2
5. Screening ALT or AST \> 1.5x upper limit of normal (ULN)
6. Screening bilirubin \> 2.0 mg / dL, or \> 3.0 mg / dL for participants with Gilbert's Syndrome
7. Current use of immunosuppressive or immunomodulatory therapies, including pharmacologic doses of systemic steroids. However, topical steroidal creams and inhaled steroids without large systemic absorption are allowed.
8. Coincident medical condition likely to require immunosuppressive or immunomodulatory therapies.
9. Coincident medical condition likely to limit short term (5 year) life expectancy (malignancy, symptomatic coronary artery disease, recent stroke)
10. Prior radiation therapy, immunotherapy (within 1 year of screening), or chemotherapy
11. Serologic evidence of current HIV-1 or HIV-2 infection
12. Serologic evidence of hepatitis C infection
13. Serologic evidence of acute or chronic active hepatitis B as measured by Core Ab positive and / or Surface Antibody antigen positive
14. Subjects with other autoimmune conditions (except compensated or treated autoimmune thyroid, celiac, alopecia, or vitiligo diseases)
15. Women who are pregnant (pregnancy testing during screening), breastfeeding, or planning pregnancy during the study period
16. Inadequate venous access to support leukapheresis
17. Any condition that in the opinion of the investigator(s) would preclude the subject from participating in a clinical trial.
18. Abnormal screening ECG that in the opinion of the investigator or sponsor would pose a safety risk.
Prevalence of Stuttering in Children With ADHD at Sohag University Hospital

The majority of the latest research suggests that stuttering is associated with significantly elevated levels of trait and social anxiety. The prevalence of children who stutter and have attention deficit/ hyperactivity disorder (ADHD) ranges from 4 to 26%. About 10-20% of children who stutter might show ADHD.

Gender ( male) is the dominant risk factor for stuttering, as also applies to other neurodevelopmental disorders. Examples include attention deficit hyperactive disorder (ADHD), conduct disorder, tics and the Gilles de la Tourette syndrome (GTS). These neurodevelopmental disorders are the second -most prominent set of comorbidities with stuttering.

Attention-deficit hyperactivity disorder (ADHD) and stuttering share many characteristics in addition to temperament . A complex interplay of neural differences, with genetic and environmental components, has been reported as a possible cause of both disorders. In addition, both may appear more frequently in boys than in girls . Furthermore, it is emphasized that childhood stuttering can be accompanied by aspects of ADHD . Likewise, children exhibiting signs of ADHD more frequently display speech disfluencies than their peers.

It is suggested that children with stuttering and those without stuttering will display different profiles in terms of temperament, certain aspects of ADHD, and some types of anxiety. In addition, it is to be expected that there will be some correlations between these variables in children who stutter. However, it is not possible to draw definite conclusions about this issue that could be generalized to all children who stutter. Furthermore, there are very few studies that deal with combinations of these variables .


Eligibility Criteria:
Inclusion Criteria:

* All children with ADHD

Exclusion Criteria:

* 1-Children ageed below 6 years old. 2- children with ADHD with other behavioral and neurological disorders.
Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

Efficacy and Safety of Ciprofol Sedation in Patients Undergoing Liver Cancer Percutaneous Radiofrequency Ablation

Ciprofol was injected before ablation and sedation scores were measured to make sure certain sedation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who intend to undergoing ultrasound-guided percutaneous radiofrequency ablation of liver tumors;
* Age: 18-75 years old;
* ASA grade I-III;
* Laboratory examination meets the following conditions: neutrophils \>1.5×109/L, platelet \>80×109/L, hemoglobin \>90g/L, aspartate transferase \<1.5×ULN, total bilirubin \<1.5×ULN, serum creatinine \<1.2 x ULN;
* Chemotherapy \< 4 times.

Exclusion Criteria:

* Patients who are known to be allergic to propofol, opioids, eggs, soy products, or patients who are contraindicated with these drugs or foods due to illness;
* serious organ dysfunction and other systemic diseases, such as liver dysfunction, renal dysfunction; Worsening congestive heart failure within the last 6 months resulting in hospitalization or adjustment of medication; Severe aortic or mitral stenosis; Heart surgery (heart valve replacement) within the last 6 months; Acute myocardial infarction in the last 6 months; Hemodynamic disturbance due to arrhythmia; Respiratory diseases; Cerebrovascular diseases; . Taking propofol, opioids or other analgesic and sedative drugs 72 hours before . Emergency surgery;
* Those who are unable to communicate with the researcher normally or who are deemed unsuitable by the researcher and refuse to participate in the study.