cyrilzakka/clinical-trials huggingface dataset:
Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes

This study looks at how well a new medicine called cagrilintide works together with semaglutide on blood sugar levels in people with type 2 diabetes compared to cagrilintide alone or semaglutide alone.

Before a new medicine can be prescribed to people it needs to be tested to see if it is safe and effective.

Participants will either get cagrilintide and semaglutide together or cagrilintide and a dummy medicine or semaglutide and a dummy medicine. Which treatment participants get is decided by chance.

A dummy medicine (placebo) looks like the study medicine but does not contain any active medicine. The dummy medicine is in the study to see if the study medicine works as expected.

Participants will get 2 injections per week on the same day. Participants will take the study medicine with a pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show how.

The study will last for about 39 weeks. Participants will have 12 visits at the clinic and 5 phone calls with the study doctor.

At 6 of the clinic visits participants must not eat and drink for 8 hours before the visit (water is allowed).

Women who can become pregnant cannot take part in this study. Only women that are surgically sterilised or post-menopausal are allowed to participate in this study Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period


Eligibility Criteria:
Inclusion Criteria:

* Female of non-childbearing potential or male
* Age above or equal to 18 years at the time of signing informed consent
* Body mass index (BMI) greater than or equal to 27.0 kg/m\^2
* Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening
* Glycated haemoglobin (HbA1c) of 7.5-10.0% (58-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening
* Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at maximum tolerated or effective dose as judged by the investigator: metformin with or without Sodium-glucose co-transporter-2 (SGLT2) inhibitor

Exclusion Criteria:

* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) below 60 ml/min/1.73m\^2 by central laboratory at screening
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Buprenorphine Dosing Interval - 5

The purpose of this study is to explore the feasibility of extending the dosing interval of well maintained buprenorphine patients to 48 and 72 hours, leading to eventual 3 times/week dosing.


Eligibility Criteria:
Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV critera. Self-reported use within the last 30 days. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hynotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.
Cold Therapy for Pediatric Appendectomy

This is a randomized control trial to evaluate the efficacy of an FDA approved cold therapy device vs. usual care among children undergoing appendectomy at a large children's hospital.


Eligibility Criteria:
Inclusion Criteria:

* Age of 7 years of older
* Diagnosis of appendicitis and scheduled appendectomy

Exclusion Criteria:

* Neurologic and Decision Impairment
* Chronic opioid dependency
* Planned ICU admission post-operatively
* Reoperation during hospital stay
* Ward of the state
* Non-english and non-spanish speakers
Icotinib in Previously Treated Non/Light-smoking Patients With Advanced Squamous Cell Lung Cancer

This study is designed to evaluate the efficacy of icotinib at routine dose in previously treated non/light-smoking patients with advanced squamous cell lung cancer.

This study is designed to evaluate the efficacy of icotinib at routine dose in previously treated non/light-smoking patients with advanced squamous cell lung cancer. An objective response (OR) was defined as a patient having a best overall response of either complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, confirmed at least 28 days following the date of the initial response.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic or recurrent squamous cell lung cancer from the primary lesion and/or lymph nodes, stage IIIB or IV patients with non-smoking or light-smoking history.
* Failure of at least 1, and no more than 2, prior chemotherapy regimens for advanced disease (either due to progressive disease or toxicity).
* Have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan.
* Be \>= 18 years of age.
* Expected survival period over 12 weeks;
* ECOG PS 0-2. Adequate organ system function as defined within the protocol.
* Patients with a history of CNS metastases or cord compression are allowed if they have been definitively treated and are clinically stable.
* Consent compliance research plan and follow-up process, and be able to carry out oral therapy; Provision of written informed consent.
* In women of childbearing age, must be in before starting treatment within 7 day of urine pregnancy test and the result is negative, and not in the lactation period, and reproductive age men and women prior to entry into the study, the research process until 90 days after stopping all agree to use reliable methods of contraception;
* Weight loss =\< 10% in past 6 months.
* Adequate tumor tissue for detection of molecular biomarkers.

Exclusion Criteria:

* Patients who have previously received treatment with EGFR-TKIs.
* Concomitant treatment with any other experimental drug under investigation or anti-tumor therapy;
* Symptomatic CNS metastases or newly diagnosed CNS metastases that have not yet been definitively treated with radiation and/or surgery.
* Known severe hypersensitivity to icotinib or any of the excipients of this product.
* Presence of uncontrolled pleural effusion or/and peritoneal effusion;
* Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
* Past or current history of neoplasm (other than the entry diagnosis) in past 5 years, with the exception of treated basal cell carcinoma or carcinoma in situ of the cervix, or other cancers cured by local therapy alone.
* Women who are lactating.or have positive pregnancy test.
Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study

Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water retention and secondary natriuresis and is a common cause for hyponatremia.

Especially chronic (\>72h) SIADH is difficult to treat as standard therapeutic options (water restriction, urea, salt tablets) often do not succeed in correction of hyponatremia, making additional therapy necessary.

Empagliflozin is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a well-tolerated treatment option for type 2 diabetes mellitus. The inhibition of SGLT2 in the proximal tubule leads to renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with chronic SIADH, as it resembles the aquaretic effect of urea.

The aim of this study is to evaluate whether empagliflozin has an effect on the serum sodium levels of patients with chronic SIADH.


Eligibility Criteria:
Inclusion Criteria:

Adult patients (age ≥ 18 years) with hyponatremia (\<133mmol/l) due to chronic (\>72h) SIADH defined as

* serum osmolality \<275mosm/kg
* urine osmolality \>100mosm/kg
* urine sodium \>30mmol/l

Exclusion Criteria:

* acute (\<72h) or transient hyponatremia
* severe symptomatic hyponatremia in need of hospital treatment
* diabetes mellitus type 1
* uncontrolled hypothyroidism
* uncontrolled adrenal insufficiency
* renal impairment (GFR \<45ml/min)
* cardiac failure
* symptomatic liver disease / severe hepatic impairment (ALAT / aspartate transaminase (ASAT) \> 3x upper limit)
* treatment with SGLT 2 inhibitors, lithium chloride, urea or glitazone
* severe immunosuppression
* pregnancy or breastfeeding
* palliative situation (end of life care)
Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg

The purpose of this study is to evaluate the effect of steady-state ranolazine 500 mg bid on the steady state pharmacokinetics (PK) of metformin in subjects with type 2 diabetes mellitus (T2DM).

The primary objective of this study is as follows:

• To evaluate the effect of steady-state ranolazine 500 mg twice daily (bid) on the steady state pharmacokinetics (PK) of metformin in subjects with T2DM.

The secondary objectives of this study are as follows:

* To examine the safety and tolerability of metformin when co administered with ranolazine 500 mg bid at steady-state in subjects with T2DM.
* To determine the steady-state PK of ranolazine 500 mg bid in subjects with T2DM receiving metformin.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 30 to 65 years old, inclusive
* Documented history of T2DM
* HbA1c 6.5%-10%, inclusive
* Fasting serum glucose ≤ 270 mg/dL at Screening
* Fasting C-peptide ≥ 1 ng/mL at Screening
* Stable metformin monotherapy (metformin ≥ 1500 mg total daily dose for at least 4 weeks prior to Screening)
* Body mass index (BMI) 25 to 40 kg/m2, inclusive, at Screening
* Creatinine Clearance \> 80 mL/min at Screening
* Females of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1 and must agree to use highly effective contraception methods from Screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug

Exclusion Criteria:

* Type 1 Diabetes Mellitus (T1DM)
* Use of insulin therapy \< 3 months prior to Screening
* History of ketoacidosis, ketosis-prone diabetes, or lactic acidosis
* Clinically significant complications of diabetes
* History of hypoglycemia
* Any non-insulin antidiabetic therapy (other than metformin) \< 2 months prior to Screening
* Any clinically significant cardiovascular event \< 2 months prior to Screening
* Clinically significant, inadequately controlled, or unstable hypertension
* Hospitalization \< 2 months prior to Screening or major surgery \< 3 months prior to Screening
* History of gastrointestinal disease or surgery that could impact drug absorption
* History of substance of alcohol or substance abuse
* Positive urine drug screen for drugs of abuse
* Positive alcohol breath test
* Any other clinically significant existing medical or psychiatric condition or one requiring further evaluation
* Treatment with selected medications
* Hemoglobin \< 12 g/dL for males; or \< 11 g/dL for females at Screening
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2.5x upper limits of normal
* Clinically significant history of hepatic disease or evidence of hepatic impairment
* Positive blood screen for hepatitis C or hepatitis B
* QTc interval \> 500 msec at Screening
* Females who are pregnant or are breastfeeding
The Safety and Efficacy of Peri-procedure Blood Pressure Management of Revascularization

Objective: Referring The relation between CEA(Carotid endarterectomy) postoperative blood flow monitoring and blood pressure, and combining patient demographics and preoperative risk factors to establish an applicable individual blood pressure controlling model. By comparing with routine antihypertensive strategies through prospective randomized controlled trials , to provide the best perioperative blood pressure control standards and strategies for each patient ,thus better ensuring the safety and efficacy of CEA .


Eligibility Criteria:
Inclusion Criteria:

* symptomatic patient with carotid artery stenosis\>=50% or asymptomatic patient with carotid artery stenosis\>=70%, according to DSA or CTA;
* without massive cerebral infarction(infarction area \>1/2 territory of middle cerebral artery) confirmed by CT or MRI;
* informed consent acquired.

Exclusion Criteria:

* lesion beyond range limit of procedure (higher than C2);
* target vascular complete occlusion or ipsilateral intracranial artery severe stenosis or complete occlusion cannot be revascularized via CEA procedure
* nonatherosclerotic carotid stenosis, such as vasculitis, dissection, congenital vascular malformation;
* history of instable angina pectoris, myocardial infarction or congestive heart failure within 6 months unable to accept systematic anesthesia;
* history of severe injury, surgery or radiotherapy on neck;
* with comorbid hemorrhagic cerebral disease such as intracranial aneurysm or vascular malformation;
* with comorbid blood system disease causing refractory coagulation dysfunction or rejection to blood or blood products perfusion;
* with other comorbidity, expected life \< 2 years;
* severe diabetes mellitus difficult to control, blood sugar \>300mg/dl;
* pregnancy or peri-natal period;
* intolerance to systematic anesthesia or surgery after adequate preparation.
* intolerance to peri-procedural drug possible to administrated;
* not cooperating or rejecting to informed consent;
Effectiveness and Process Evaluation of the Injury-preventive Program #Utviklingsklar

The majority of injuries among Norwegian youth occur in sports. The purpose of the project is to conduct an effect and process evaluation of the intervention #Utviklingsklar, an injury-preventive club-based intervention in youth handball and football. Central to the evaluation is whether the intervention influences the occurrence of new and recurring injuries through changed coaching practices (injury prevention warm-up, strength training, and management of players with pain and injuries). Over one season, participants from 30 clubs in youth handball and football respectively will participate in two cluster-randomized studies. Coaches and club leaders implement #Utviklingsklar and create plans and practices for injury prevention. The control clubs train as usual. Players report injuries. An additional handball and football club are followed up with observation and interviews in a qualitative part of the process evaluation. The project provides knowledge about how injuries and health in the ¾ of Norwegian youth who participate in organized sports are affected by interventions aimed at club and coaching practices.


Eligibility Criteria:
Inclusion criteria:

-Clubs are eligible for participation if they are able to participate with one club leader, 2-6 teams, and a minimum of one coach from each of the participating teams

Exclusion criteria:

* Players under the age of 12
* Coaches under the age of 16
Accuracy Evaluation of SIS Software-based Visualization of New Anatomical Brain Structure

SIS has developed a software technology, based on machine learning and image processing, designed to enhance standard clinical images for the visualization of anatomical structures.

A cohort of 34 subjects will be scanned on a clinical MRI scanner as well as on a 7 Tesla (7T) scanner. Images acquired on the 7T allow to visualize anatomical structures that are not easily identified on standard clinical images.

SIS software will be used to visualize selected anatomical features on the clinical image and the results will be compared with the images in the same subject obtained from the 7T MRI.

Eligibility Criteria:
Inclusion Criteria:

* All subjects that are willing to be scanned on a 3T and 7T MRI scanners and are not excluded by the exclusion criteria below.

Exclusion Criteria:

1. MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g,. heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh/coil implants, neurostimulator, insulin pump, IVC filter, artificial knee or hip, metal plates, pins, screws or wires anywhere in the body, any other metal implants, etc.
2. Pregnant women.
3. Subject under the age of 18.
A Real-world Evidence Study of BNT162b2 mRNA Covid-19 Vaccine Among Children in Brazil

The present test-negative design study aims to estimate the real-world effectiveness of Pfizer-BioNTech BNT162b2 mRNA vaccine on symptomatic SARS-CoV-2 infection and its consequences among children aged 5 to 11 years in the city of Toledo in Southern Brazil.

Individuals aged 5 to 11 years who seek the public healthcare system with symptoms suggestive COVID-19 will be enrolled. Participants with a positive reverse transcriptase polymerase chain reaction (RT-PCR) test for SARS-CoV-2 will be classified as cases, and those with negative RT-PCR test for SARS-CoV-2 will be classified as controls. Cases will be followed-up for a period of 3 months by means of structured telephone interviews.


Eligibility Criteria:
Inclusion Criteria:

* Age between 5 and 11 years;
* Resident of Toledo city;
* Seeking care in the public healthcare system with symptoms suggestive of COVID-19 defined as follows: 1) ARI symptoms (nasal congestion, rhinorrhea, anosmia, sore throat, hoarseness, new or increased-from-baseline cough, sputum production, dyspnea, wheezing, myalgia) OR 2) Admitting diagnosis suggestive of ARI (pneumonia, upper respiratory infection, bronchitis, influenza, cough, asthma, viral respiratory illness, respiratory distress, AND/OR respiratory failure).
* Nasal or nasopharyngeal sample for SARS-CoV-2 test obtained as standard of care.

Exclusion Criteria:

* SARS-CoV-2-directed antiviral treatment within the past 30 days;
* COVID-19 monoclonal antibody therapy within the past 90 days;
* COVID-19 convalescent serum therapy within the past 90 days;
* Failure to perform RT-PCR for diagnosis of SARS-CoV-2 infection.
Evaluation and Modeling of the Effect of G-CSF on the Evolution of Polynuclear Neutrophils During Dense Dose Epirubicin-Cyclophosphamide Regeneration

Patients including of localized breast cancer will require chemotherapy treatment with epirubicin - cyclophosphamide (EC) followed by treatment with docetaxel or paclitaxel. In addition to this chemotherapy, the investigator will prescribe injections of granulocyte growth factors (G-CSF), to stimulate the growth of white blood cells. Patients will be randomized to either a peg-G-CSF arm or a G-CSF arm, prescribed at different times.

The aim is to determine whether one of the two treatment regimens best limits the risk of a decrease in white blood cells

For this tudy : patients will be randomized to either :

* with administration of peg-G-CSF (administration on D2)
* with administration of G-CSF (administration on D4 to D7 or D8)

This study aims to model the effect of exogenous G-CSF for the evolution of polymorphonuclear neutrophils as a function of time and to explain the pharmacodynamic variability during the administration of chemotherapy such as EC-dense dose administered as an adjuvant or neo-adjuvant in patients treated for localized breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Patient over 18 years old
* Patient with histologically documented, non-metastatic breast cancer who must receive dense dose Epirubicin-Cyclophosphamide (EC) type treatment as part of neoadjuvant or adjuvant treatment
* Patient to receive granulocyte growth factors (G-CSF or peg-G-CSF) as a preventive measure from the first cycle
* Neutrophils \> 1,500 /mm3; platelets \> 100,000 /mm3
* Written informed consent, dated and signed
* For patients of childbearing age, effective means of contraception during treatment and up to 3 months after stopping treatment

Exclusion Criteria:

* Patient with a contraindication to treatment with anthracyclines
* Patient already undergoing treatment with EC dense dose
* Patient with a contraindication to treatment with G-CSF such as hypersensitivity to the active ingredient or to one of the excipients
* Pregnant or breastfeeding women
* Patient under guardianship or curatorship or subject to a protection regime for adults
* Patient not affiliated to a social security scheme (beneficiary or beneficiary)
A Study of COVID-19 Patients Receiving Treatment With Nirmatrelvir; Ritonavir in the Kingdom of Saudi Arabia

The aim of this study is to describe the baseline demographic, clinical characteristics, and Healthcare Resource Use (HCRU) of adult (≥18 years) COVID-19 patients who have been prescribed nirmatrelvir, ritonavir treatment.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 infection during the study observation period
* Nirmatrelvir, ritonavir written prescription

Exclusion Criteria:

* None
Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease

This is a single-arm, open label, multicenter clinical study to evaluate the handling and safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease followed by an optional extension phase of AVT06 pre-filled syringe (PFS)


Eligibility Criteria:
Inclusion Criteria :

* Male or female ≥18 years old
* Subjects with diagnosis of nAMD (wet), DME, RVO, DR, or myopic CNV in the study eye
* Study eye considered by the Principal Investigator to be indicated for treatment with aflibercept
* Subjects must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form (ICF) before any study-specific procedures
* Willing and able to comply with all study procedures and be likely to complete the study
* Subjects must be able to follow the contraception requirements

Exclusion Criteria (selected):

* Any concurrent ocular condition in the study eye which, in the opinion of the Principal Investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of safety
* Current systemic infectious disease or a therapy for active infectious disease Any condition that, in the Principal Investigator's opinion, can interfere with full participation in the study, including administration of the study treatment and attending required visits; can pose a significant risk to the subject, or interfere with interpretation of study data