cyrilzakka/clinical-trials huggingface dataset:
Insulin-based Strategies to Prevent Hypoglycemia During Exercise

It has been reported that insulin basal rate reduction initiated at exercise onset can reduce the hypoglycemic risk during exercise. However, another potentially more efficient strategy to prevent exercise-induced hypoglycemia could be to reduce insulin basal rate a certain time prior to exercise. No study investigated what would be the best timing to initiate such temporary basal insulin reduction. Therefore, the objective of this study will be to compare the efficacy of three strategies to prevent exercise-induced hypoglycemia during a 45 min exercise at 60% VO2peak (moderate intensity): 1) reduce insulin basal rate at the time of exercise; 2) reduce insulin basal rate 20 minutes prior to exercise; 3) reduce insulin basal rate 40 minutes prior to exercise. Investigators hypothesize that the time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction at the time of exercise. Secondary hypotheses are: 1) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 20 minutes prior to exercise compared to a reduction at the time of exercise; 2) Time spent in hypoglycemia will be less when the insulin basal rate is reduced 40 minutes prior to exercise compared to a reduction 20 minutes prior to exercise.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. The subject will have been on insulin pump therapy for at least 3 months.
4. Last (less than 2 months) HbA1c ≤ 12%.

Exclusion Criteria:

1. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
2. Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Abnormal blood panel and/or anemia.
4. Ongoing pregnancy.
5. Severe hypoglycemic episode within two weeks of screening.
6. Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
7. Failure to comply with team's recommendations (e.g. not willing to change pump parameters, etc.).
Feasibility and Safety Study of the Endologix Fenestrated Stent Graft System

The aim of this study is to evaluate the safety and feasibility of the Endologix Fenestrated Stent Graft System for the endovascular repair of juxtarenal or pararenal aortic aneurysms.

The Endologix Fenestrated Stent Graft System that will be used in this study has three components, listed below:

1. Endologix unibody bifurcated stent graft
2. Endologix fenestrated proximal extension stent graft
3. Endologix renal stent graft

Eligibility Criteria:
Inclusion Criteria:

* Adequate iliac/femoral access compatible with the required delivery systems
* Non-aneurysmal infrarenal aortic neck \<15mm in length
* Most caudal renal artery to aortoiliac bifurcation length \>= 70
* SMA to aortoiliac bifurcation length \>=90mm
* Proximal non-aneurysmal aortic neck below the SMA with diameter 18 to 34 mm, length \>=15mm and angle \<=60° to the aneurysm sac
* Angle \<=60° (clock face) between the SMA and CA
* Renal arteries both at or below the SMA by \<=35mm and within 30mm of each other axially, with 4 to 8mm lumen diameter, and with clockface angle of 90° to 210° to each other
* Common iliac artery distal fixation site with: distal fixation length \>=15mm, with diameter \>=10 mm and \<=23 mm and angle \<=90° to the aortic bifurcation
* Ability to preserve at least one hypogastric artery

Exclusion Criteria:

* Life expectancy \<2 years as judged by the investigator
* Psychiatric or other condition that may interfere with the study
* Participating in the enrollment or 30-day follow-up phase of another clinical study
* Known allergy to any device component
* Coagulopathy or uncontrolled bleeding disorder
* Contraindication to contrast media or anticoagulants
* Ruptured, leaking, or mycotic aneurysm
* Aortic dissection Serum creatinine (S-Cr) level \>2.0 mg/dL
* Traumatic vascular injury
* Active systemic or localized groin infection
* Connective tissue disease (e.g., Marfan's Syndrome)
* Recent(within prior three months)cerebrovascular accident
* Recent(within prior three months)myocardial infarction
* Prior renal transplant
* Length of either renal artery to be stented \<12mm
* Significant occlusive disease or calcification of either renal artery (\>70%)
* An essential accessory renal artery
* Indispensable inferior mesenteric artery
* Untreated aneurysmal disease of the descending thoracic aorta
* Clinically significant mural thrombus circumferentially in the suprarenal segment
* Prior iliac artery stent implanted that may interfere with delivery system introduction
* Unsuitable vascular anatomy
* Pregnancy
Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 1)

This is a single center phase 1 trail to observe safety and efficacy of metronomic capecitabine plus PD-L1 antibody camrelizumab as third-line regimen to treat HER2 negative advanced gastric cancer patients.

This study is one of the cohorts of a multi-cohort trial called Combination of Metronomic capecitabine with Camrelizumab for treatment of refractory solid tumor (McCrest) trial.

HER2 negative advanced gastric cancer patients who have disease progression after two standard regimens will be treated by metronomic capecitabine plus camrelizumab. Metronomic capecitabine will be given as fixed dose (500mg bid) orally. Camrelizumab will be given two-weekly (200mg once) intravenously. This regimen will be administered until progression of disease, intolerable toxicity or withdraw of consent.

Eligibility Criteria:
Inclusion Criteria:

1. Male/female patients aged≥18 years.
2. Histologically confirmed gastric or gastric esophageal junction adenocarcinoma, without uncontrolled pleural effusion or ascites.
3. Patients with advanced or metastatic disease who have disease progression after two standard regimens, with measurable or unmeasurable lesions.
4. HER2 negative, MSS or pMMR.
5. ECOG performance status 0 or 2, expected lifetime≥3 months.
6. Adequate organ function: Absolute neutrophil count (ANC) ≥1.5x109/L, White blood count ≥3.5x109/L, Platelets ≥75x109/L, Hemoglobin (Hb) ≥70g/L, ALT/AST ≤2.5x ULN (for patient with liver metastasis ALT/AST ≤5x ULN), Serum bilirubin ≤1.5x ULN, Serum creatinine ≤1.5x ULN.
7. HBV infected patients (inactive/asymptomatic carrier, chronic or active) with HBV DNA\<500IU/ml (or 2500 copies/ml).
8. Pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. Patients should keep contraception during treatment.
9. Willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form.

Exclusion Criteria:

1. Pregnancy or children bearing potential.
2. brain or meningeal metastasis.
3. With second primary malignant diseases.
4. With uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone).
5. With uncontrollable complications
6. Inadequate organ function
7. Conditions which impact on pill taking (dysphagia, chronic diarrhea, bowel obstruction).
8. known hypersensitivity reaction to any of the study drugs or components.
9. Other unsuitable conditions determined by investigators.
Safety of Liraglutide in Pediatric Patients With Type 2 Diabetes

This trial is conducted in Europe and the United States of America (USA). The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of multiple doses of liraglutide in the pediatric population (children).


Eligibility Criteria:
Inclusion Criteria:

* BMI greater than 85th percentile for age and gender
* Currently being treated with diet and exercise or metformin alone
* HbA1c (glycosylated haemoglobin) between 6.5 and 11.0%

Exclusion Criteria:

* Any clinically significant disease other than type 2 diabetes, as judged by the trial physician
* Previous treatment with any anti-diabetic drug other than metformin (except for prior short term treatment, at the discretion of the trial physician)
A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma

To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.


Eligibility Criteria:
Inclusion Criteria:

* Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

Exclusion Criteria:

* Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
* History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening
Pilot fMRI Studies of Aging-Related Effects of THC

The purpose of this study is to begin investigating acute impairment of various forms of memory and learning by Tetrahydrocannabinol (THC) in cannabis (CNB) compared to placebo, in a 2-session per subject double-blind, random assignment, placebo-controlled counterbalanced design in young to middle-aged adults.

Tasks tapping each of the major cognitive memory-related domains will be performed in the MRI scanner, to reveal the relevant underlying circuitry and its disruption by drug using functional MRI.

On an initial Screening Visit, regular or novice cannabis (CNB) users will undergo informed consent, clinical assessment (to fully evaluate inclusion/exclusion criteria), cognitive/personality assessment, and a structural MRI scan.

At each assessment, subjects will provide subjectively-rated CNB intoxication using a verbal analog scale, complete 2 fMRI paradigms within \~1.5 hours: a) Card Guessing task and b) Complex Working Memory Span, and complete the computer-based Effort Expenditure for Reward Task within \~2 hours. These tests will be counterbalanced across subjects and sessions to minimize order and fatigue effects. Breaks will be standardized in a private environment and snacks/meals provided. Bathroom visits given as needed. Subjects will be supervised at all times by study staff and vital signs monitored. On assessment days, participants will remain at the Olin NRC until they report no subjective intoxication, and are observed by study staff to be no longer objectively intoxicated, then use taxi or Uber transportation home.

Eligibility Criteria:
Inclusion Criteria:

* CNB use within past 2 years and felt "high" when used.
* Able to read, speak, and understand English.
* Able and willing to provide written informed consent, and willing to commit to the study protocol.

Exclusion Criteria:

* Current marijuana tolerance, desire to cut down, or cravings to use during periods of abstinence.
* Positive screen for drug or alcohol (except CNB) on test day will result in rescheduling the appointment
* History of adverse effects with CNB
* CNB users who are abstaining
* IQ \<80 on the Wechsler Abbreviated Scale of Intelligence
* Inability to comprehend written instructions using the WRAT 4 reading achievement test
* Pregnant, breastfeeding, and ineffective birth control methods
* Unable or unsafe to have an MRI
* Serious medical, neuro-ophthalmological, or neurological illness (e.g. cancer, seizure disorders, encephalopathy
* History of head trauma with loss of consciousness \> 30 minutes or concussion lasting 30 days
* Focal brain lesion seen on structural MRI
* Any medical/neurological condition that could compromise neurocognitive performance (e.g. epilepsy, multiple sclerosis, fetal alcohol syndrome)
* Anyone deemed unsafe to study personnel for any reason
* Hearing loss such that subject cannot hear sounds at the levels (dB) or pitches (Hz) to be used in the study
* Significant pain and/or reduced mobility in the arms
Effect of Education Based on The Health Belief Model on Healthy Lifestyle Behaviors in Individuals With Type 2 Diabetes

This research will be carried out with a randomized controlled experimental design to examine the effect of education based on the Health Belief Model for individuals with Type 2 Diabetes on their health beliefs, self-efficacy and healthy lifestyle behaviors.

During the research, the relevant polyclinic will be visited regularly. The patients who are followed up in the outpatient clinic for type 2 diabetes will be evaluated in terms of sampling eligibility criteria and their willingness to participate in the research will be questioned. The patients to be included in the study will be randomly assigned to intervention and control groups using the random sampling method. In determining the sample size, two groups, intervention and control, were compared using the "G\*Power v3.1.9.4" program. Effect size (d) = 0.80, type I margin of error (α) = 0.05, minimum sample volume to provide test power (1-β) = 0.90, total 68 (experimental group 34, control group 34) is sick. However, it is planned to recruit 20% more patients (41 experiment, 41 control) in order to increase the power and reliability of the research, and there may be losses in the research process.

In the collection of research data; Introductory Characteristics Information Form, Diabetes Health Belief Model Scale, Diabetes Self-Efficacy Scale and Healthy Lifestyle Behaviors Scale-II will be applied.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with Type 2 Diabetes in the last 6 months
* Being between the ages of 18-65
* HbA1c ≥ 6.0%
* Taking oral antidiabetic medication and/or insulin therapy
* Understanding and speaking Turkish
* Being literate
* Living in Konya
* Not having a communication problem
* Being able to use the WhatsApp® application
* Not having internet access problems
* Individuals who agree to participate in the research by giving their verbal and written consent will be included.

Exclusion Criteria:

* Having a vision problem
* Having mental and communication problems
* Having a neuropsychiatric disorder
* Having a history of malignant disease
* Being pregnant
Higher Dose Weekly Topotecan In The Treatment Of Patients With Extensive Stage Small-Cell Lung Cancer

This proposed phase II trial will investigate weekly topotecan at a higher dose than was used in the previous trials in an attempt to achieve improved response rates and disease control without added toxicity. To help ameliorate the fatigue, planned rest weeks will be incorporated into the schedule. This trial will be the first clinical trial to evaluate a higher dose of weekly topotecan in the treatment of extensive-stage SCLC.

All patients will receive weekly topotecan.

Topotecan 6mg/m2 IV weekly x 6 consecutive weeks followed by a 2 week break. Cycles are repeated every 8 weeks, for 3 cycles. Restaging studies will be performed every cycle (or 8 weeks.)

Eligibility Criteria:
Inclusion Criteria:

* Extensive small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen
* Measurable or evaluable disease
* Able to perform activities of daily living with minimal assistance
* Adequate bone marrow, liver and kidney function
* May have received no more than 3 previous courses of radiation therapy
* Give written informed consent prior to study entry

Exclusion Criteria:

* Patients with limited stage disease
* History of a prior malignancy within three years
* Female patients who are pregnant or are breast feeding
* Significant history of uncontrolled cardiac disease
* Myocardial infarction or stroke within six months
* Symptomatic peripheral vascular disease
* CNS involvement
* Serious active infection or underlying medical condition
USE OF ARTIFICIAL INTELLIGENCE IN A PULMONARY FIBROSIS CLINIC

The present study aims to evaluate the usefulness of artificial intelligence (AI) in the back-office of an ILD (Interstitial Lung Disease) clinic.


Eligibility Criteria:
Inclusion Criteria:

- Patients attending ILD clinic of the IRCCS Fondazione Policlinico A. Gemelli.

Exclusion Criteria:

* Patients unable or unwilling to sign the informed consent
* Patients who are senders of one of the emails chosen for the questionnaire
* Patients with manifest inability to fill out the questionnaire
A Rehabilitation Program Based on Daily Activities in Patients With Cerebrovascular Accident

Mixed qualitative and quantitative study, in two phases:

Creation of a self-rehabilitation program based on people's daily living activities and designed with and for them.

Randomized controlled study to explore whether there is a potential benefit for patients with chronic stroke to use a self-rehabilitation program.

In France, stroke affects nearly 150,000 people per year and is therefore a major problem public health in France but also in Europe . With improved support treatment, the mortality rate decreases, but the sequelae, linked to the consequences of the stroke, remain numerous . More than 88% of stroke victims return at home upon discharge from hospital rehabilitation. However more and more people experience difficulties as a result of this return. Hospital discharge entails an imbalance between the period of hospitalization and place of residence in terms of the frequency and intensity of rehabilitation. In fact, the person benefits from rehabilitation during his hospitalization daily. After returning home, the person no longer benefits only 1 to 2 rehabilitation sessions per week, sometimes less . In view of these different elements, the investigators issue the assumption that making available to people AVC a self-rehabilitation program designed with and for them and centered on the meaningful occupations of the person will allow an increase in their occupational performance in their life activities daily. The aim of this study is to create a self-rehabilitation program based on people's daily living activities and designed with and for them and to evaluate the benefits of this program with a randomized controlled study.

Eligibility Criteria:
Inclusion Criteria:

* Having had a stroke ischemic or hemorrhagic for more than 6 months before inclusion in the study.
* Having had a single cerebral hemispheric lesion
* Patient informed and having signed consent

Exclusion Criteria:

-Patient under guardianship or curatorship

* Pregnant or breastfeeding women
* Cognitive impairment defined by BDAE \<3
* Previous operation of the paretic limb at course of the last 6 months at inclusion
* Total absence of motor skills in the upper limb hemiplegic
To Evaluate the Safety and Initial Efficacy of STSA-1002 Injection in Patients with Acute Respiratory Distress Syndrome

To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old≤Age≤85 years old;
2. Pathogen results indicate respiratory viral infection;
3. Acute respiratory distress syndrome (ARDS) caused by viral pneumonia;
4. In 14haode days since the onset of respiratory infective symptoms (in 12 days for non-invasive mechanical ventilation patients);
5. PaO₂/FiO₂ ≤200 mmHg based on arterial blood gas analysis prior to randomization;
6. Most recent peripheral blood lymphocyte count ≤0.8×10\^9/L prior to randomization;
7. Patients (including patients' partners) has no plans for conception during the study period and within 4 months following the last dose, and agrees to use appropriate and effective contraception (e.g., birth control pills, condoms);
8. Willing to participate in the study and signs the informed consent form

Exclusion Criteria:

1. Use of ECMO before the first administration;
2. More than 48 hours of invasive mechanical ventilation prior to the first dose;
3. Based on the researchers' overall assessment, the patient's condition improved within the first 48 hours prior to the initial dosing (predictable improvement in oxygenation indicators observed within the next 48 hours);
4. Expected survival period of less than 24 hours or a history of cardiac arrest within 4 weeks prior to screening;
5. Recent history of stroke or acute coronary syndrome;
6. Diagnosed with fungal pneumonia (Aspergillus, Mucor, Cryptococcus, or Pneumocystis jirovecii pneumonia);
7. Suspected or known cytomegalovirus infection;
8. Suspected or known active tuberculosis;
9. Experienced prolonged fluid resuscitation-resistant septic shock.
10. Severe chronic respiratory failure;
11. Deemed by the investigator as difficult to wean from ventilation due to severe underlying diseases;
12. Cardiogenic pulmonary edema or congestive heart failure;
13. Liver dysfunction;
14. Severe renal impairment or long-term dialysis;
15. Immunocompromised state;
16. A Absolute neutrophil count is excessively low;
17. Severe anemia or active bleeding;
18. Poor compliance with standard treatment;
19. Pregnant or breastfeeding women;
20. Participated in a clinical trial of a new drug and received treatment within 3 months prior to screening;
21. Any condition that the investigator believes may increase the risk to the patient or interfere with the execution of the clinical trial;
22. Known allergy to any component of the investigational drug or its excipients, or a history of hypersensitivity (e.g., allergic to two or more drugs);
23. Any other disease or condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study;