cyrilzakka/clinical-trials huggingface dataset:
A Dose Escalation, Dose Expansion Study to Evaluate the Safety, Tolerability, and Antitumor Activity of MEDI-575, in Subjects With Advanced Tumors.

Evaluate the safety, tolerability and the tolerated maximum dose of MEDI-575 in adult subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced solid tumor for which no curative or standard therapies exist
* Karnofsky performance status of ≥ 60
* Life expectancy of \>12 weeks
* Adequate hematologic and organ function
* Negative serum pregnancy test (women only)
* Two methods of birth control for female participants of child-bearing potential or male participants with their female partners of child-bearing potential

Exclusion Criteria:

* Prior chemotherapy or investigational treatment within 4 weeks of study drug administration
* Prior biological or immunological treatment within 6 weeks of study drug administration
* Concurrent therapy for of cancer
* Major surgery within four weeks or minor surgery within two weeks of study drug administration
* History of diabetes or current treatment for diabetes
* New York Heart Association ≥ Grade 2 congestive heart failure
* History of myocardial infarction, unstable angina, transient ischemic attack or stroke within the previous 6 months prior to study entry
* History of other invasive malignancy within 5 years (exceptions are cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that are surgically cured)
* Significant active infection
* Known brain metastases
* Pregnancy or lactation or plans to become pregnant while on study
* Clinically significant abnormality on ECG
Gas Transfer on ILA-Activve

Oxygenatuion and decarboxylation during different settings (steps of blood flow and sweep gas flow) of extracorporeal gas exchange by ILA Activve using a jugular 22French double lumen cannula are measured.


Eligibility Criteria:
Inclusion Criteria:

* Patient on ILA Activve
* Controlled mechanical ventilation
* No spontaneous breathing

Exclusion Criteria:

- Pregnancy
AMCPR (Augmented-Medication CardioPulmonary Resuscitation) Trial for OHCA

The investigators aimed to evaluate the effect of AMCPR (Augmented-Medication CardioPulmonary Resuscitation: administration of additional vasopressin to titrate to arterial diastolic blood pressure over 20 mmHg) on cardiopulmonary resuscitation results and outcomes in out-of-hospital cardiac arrest patients.

Non-traumatic out-of-hospital cardiac arrest patients receive standard advanced cardiac life support according to the 2015 AHA guideline, including chest compression, intubation, ventilation, defibrillation, drug administration, including epinephrine and antiarrhythmic drugs if indicated, in the emergency department.

A research associate generates a random sequence using Excel software, and assignment of participants to their respective groups will be undertaken by the principal investigator.

Arterial line insertion is performed within 6 minutes after randomization and diastolic blood pressure will be monitored.

If diastolic blood pressure is \< 20 mmHg, drugs (vasopressin 40 IU or normal saline) will be administered for two times during CPR.

Arterial blood gas analysis will be analyzed for 5, 10, 15, and 20 minutes after arterial line insertion or termination of CPR.

End-tidal carbon dioxide concentrations is monitored in real time during CPR and recorded every minute.

The resuscitated patients receive standard post cardiac arrest care according to the 2015 AHA guideline.

Eligibility Criteria:
Inclusion Criteria:

* non-traumatic adult out-of-hospital cardiac arrest (OHCA) patients with non-shockable arrest rhythm

Exclusion Criteria:

* OHCA with terminal illness documented by medical record, under hospice care, with pregnancy, with pre-documented 'Do Not Resuscitate' card
* trauma patients
* age \< 18 years old
* failed arterial line insertion within 6 minutes after randomization
* Extracorporeal cardiopulmonary resuscitation
* Time interval between arrest and ED arrival \> 60 minutes
* ROSC within 6 minutes after ED arrival
* Diastolic Blood Pressure \> 20 mmHg during resuscitation
Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women

The purpose of the study is to evaluate the real-world effectiveness and cardiovascular safety of ABL compared with TPTD during the 18-month period after treatment initiation in propensity score (PS)-matched cohorts

This is a retrospective observational cohort study using healthcare administrative claims data from the USA.

This study will use anonymized patient claims data from PRA's Symphony Health Patient Source Integrated Dataverse (IDV) database including the enhanced hospital data. Data are routinely collected in healthcare encounters from all available healthcare sites (inpatient hospital, outpatient hospital, physician office, pharmacy, etc.) for all types of provided services including specialty, preventive care, and office-based treatments.

The patients for inclusion in the study analyses will be identified based on the prescribed anabolic therapy filled (ABL or TPTD). The identification period (May 1, 2017 to June 30, 2019) was chosen to coincide with the date of the FDA approval of ABL in the USA.

Eligibility Criteria:
Inclusion Criteria:

* Women who are 50 years or older
* ≥1 prescription fill for ABL or TPTD during the identification period
* ≥ 1 claim for medical or hospital visit and a pharmacy claim in the 12 months before the index date

Exclusion Criteria:

* Paget's disease
* Malignancy, except for nonmelanoma skin cancers, carcinoma in-situ of the cervix, ductal carcinoma in-situ of breast
* Indicators of high disease burden and high risk of death
* With prior index anabolic treatment
* Switch to a different anabolic treatment after index date
The Impact of Initiating/Switching to Insulin Detemir on Emotional Well-being and Treatment Satisfaction

This study is conducted in Europe. The aim of this study is to assess the well-being of patients following treatment with insulin detemir (Levemir®) in subjects with type 1 or type 2 diabetes in whom either initiation of or a switch to insulin treatment with a long-acting basal insulin analogue is needed.


Eligibility Criteria:
Inclusion Criteria:

* Any subject with type 1 or type 2 diabetes not optimally controlled (HbA1c above 7.5%) in whom at the discretion of the participating physicians it was decide to either initiate or switch to a treatment with a long-acting insulin analogue
* Subjects with type 1 diabetes should have been treated with insulin for at least 12 months
* Potential pre-study treatment with insulin detemir (Levemir®) should have started no more than two months before baseline
Robotic Assistance for Tunnel Positioning in Anterior Cruciate Ligament Reconstruction

Accurate ideal graft tunnel positioning is essential for the successful application of anatomic anterior cruciate ligament (ACL) reconstruction. The accurate insertion of the tibial tunnel (TT) and femoral tunnel (FT) remain a challenge.

A robotic assisted new strategy for drill TT and FT in ACL reconstruction will be performed and its efficacy and accuracy will be assess.

The investigators will prospectively include 30 patients with ACL rupture requiring surgical treatment. The reconstruction will be performed with hamstring tendon graft or patellar tendon graft. The femoral and tibial tunnels placement will be guided by the Rosa robot (Zimmer®).


Eligibility Criteria:
Inclusion Criteria:

* All patients treated at CHU Amiens-Picardie for ACL reconstruction by practitioner who has robot experience.
* children and adults from 10 to 45 years old

Exclusion Criteria:

* Patients managed by another ACL reconstruction technique
* Patients under guardianship, curators deprived of liberty
* Pregnant and nursing women.
* Patient who refused to participate in the study and to sign informed consent
A Prospective, Non-Randomized Pivotal Clinical Investigation to Demonstrate the Safety and Performance of the TrueCross Single-Use Microcatheter

The trial is a pivotal clinical investigation, which is a prospective, non-randomized pivotal clinical investigation to demonstrate the safety and performance of the TrueCross Single-use Microcatheter.

The objective of this clinical investigation is to evaluate the performance and safety of the TrueCross Single-use Microcatheter in patients requiring a PCI procedure as well as the related clinical benefits.

The study will include 59 subjects suffering from coronary artery disease requiring a percutaneous coronary intervention. Enrollment duration will be 4 months or so without follow-up. It is a single-arm trial.In the uneventual case of a potential dropout (serious protocol deviation or procedure interruption unrelated to the catheter), subjects will be replaced to reach 59 evaluable subjects for the Per Protocol population.

Eligibility Criteria:
Inclusion Criteria:

i. Subjects who are \>25 years of age. ii. Subjects who are able/willing to provide a written informed consent prior to participating in the clinical investigation.

iii. The subject is male or, if female, is either not of childbearing potential or must use effective contraception during participation in this Clinical Investigation.

iv. Subject suffering from coronary artery disease requiring percutaneous coronary angiography and/or intervention.

v. Lesions classified as CTOs, meaning, TIMI 0 flow within the occluded segment and angiographic or clinical evidence or high likelihood of an occlusion duration \> 3 months vi. Reference vessel diameter ≥2 mm.

Exclusion Criteria:

i. Coronary angiography and/or intervention contraindications. ii. Subjects with severe arrhythmia. iii. Subjects with severe systemic infection. iv. Subjects with severe coagulation disorder. v. Subjects with severe heart failure, unstable decompensated heart failure, congestive heart failure, or dyspnea who are unable to lie supine on the examination table for angiography.

vi. Subjects with prior coronary artery spams or prior heart valve replacement. vii. Currently participating in an investigational drug or another device clinical investigation that has not completed the primary endpoint or that clinically interferes with the current clinical investigation endpoints.
Effect of Suction Drains in Total Knee Arthroplasty With Tranexamic Acid

Problem Suction drains during TKA present certain costs to the health system and requires additional nursing care. There is no clear evidence that supports their use, and no studies so far have compared blood loss in patients with or without drains when TA is administered during TKA.

Hypothesis During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used.

Method

* Randomized controlled trial
* Monocentric, 3 surgeons
* Randomisation by sealed envelopes

During total knee arthroplasty, the postoperative blood loss, measured by hemoglobin level, will be lower when no drains are used.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral primary total knee arthroplasty

Exclusion Criteria:

* TKA revision
* Bilateral TKA
* Patients that refuse transfusions
* Contraindication to tranexamic acid use: allergy, thromboembolic history
* Coagulopathy
* Kidney failure
The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of PONV

The incidence of postoperative nausea and vomiting (PONV) after thyroidectomy have been shown to be relatively high compared other surgeries, with a reported incidence 65-75 %. PONV may increase patient discomfort, delay patient discharge, and increase the cost of patient care, the risk of postoperative bleeding which may potentially cause airway obstruction.

It is reported that the maintenance of anesthesia with propofol-remifentanil or sevoflurane-propofol-remifentanil decreased the incidence of PONV compared sevoflurane alone, but failed to demonstrate the decreased incidence of PONV in 6-24 hr postoperative period in patients undergoing thyroidectomy. Administration of Palonosetron, newly developed 5-HT3 antagonists with long half life (48 hrs) may decrease the incidence of PONV particularly during this period.

The purpose of this study was to evaluate and compare the incidence of PONV after thyroidectomy with three different anesthetic methods, sevoflurane or sevoflurane-propofol-remifentanil or sevoflurane-propofol-remifentanil-palonosetron in woman patients.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing thyroidectomy euthyroid status American Society of Anesthesiology Physical status 1,2

Exclusion Criteria:

* Ideal body weight \>130% gastrointestinal disease prior administration of anti-emetics (24hr)
Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Trial

This research project aims to conduct a three-arm multi-center randomized controlled trial (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term integrated telerehabilitation involving exercise training at home, telemonitoring, and education/self-management will prevent hospital readmissions, thus reducing healthcare costs, for patients with COPD, and will improve patient status and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD
* At least one COPD-related hospitalization or COPD-related emergency department presentation in the previous 12 months to enrollment
* Capable to provide signed written informed consent

Exclusion Criteria:

* Attendance to a rehabilitation program in the previous 6 months of enrollment
* Participation in another study that may have an impact on the outcome of this study
* Deemed by the health care team to be physically uncapable to perform the study procedures
* Presence of comorbidities wich might prevent the patient from safely undertake an exercise program at home
* Home environment not suitable for installation and use of rehabilitation and monitoring equipment (e.g. physical space, Wi-FI Internet or mobile Internet via 4G)
A Clinical Study of MK-1708 in Healthy Elderly Participants (MK-1708-005)

The purpose of this study is to learn about the safety of MK-1708, and how well elderly people tolerate it. The study will also measure what happens to MK-1708 in a healthy elderly person's body over time (pharmacokinetic or PK study). Researchers will learn if at least 1 dose level of MK-1708 will be safe, well-tolerated, and will be above a certain level in people's blood after 24 hours.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer (malignancy). Participants with definitively treated disease who, in the opinion of the study investigator, are highly unlikely to have a recurrence for the duration of the study may be enrolled at the discretion of the investigator
Evaluation of the Use of the GenXpert to Detect Hepatitis C RNA

The results of the GX device are equivalent to standard venous blood sampling. With this study we are going to determine the prevalence in drug users with difficult venous access. On the other hand, we want to look at the place this device can have in primary care.


Eligibility Criteria:
Inclusion Criteria:

* Have recently or ever used drugs
* Older than 18 years
* Written informed consent

Exclusion Criteria:

* Not being able to speak the Dutch language
Evaluation of Outcomes of Robotics Rehabilitation in Cerebral Palsy

The use of robotic devices in rehabilitation programs can improve walking patterns by reorganizing joint kinematics. This study aims to quantify the effects of a rehabilitation program supported by the Lokomat (Hocoma) robotic device on walking in children and young people with movement disorders, considering different levels of impairment.

Cerebral Palsy is one of the most common neuromotor disorders in pediatric age, characterized by permanent movement and posture impairments, often affecting walking. In recent decades, advancements in robotics have revolutionized rehabilitation. Studies have shown that combining conventional physiotherapy with robotic rehabilitation tools offers greater benefits in patient recovery. At the IRCCS Eugenio Medea, a robotic rehabilitation program using the Lokomat (Hocoma) has been implemented for several years to improve walking in children and young people with walking disorders. The investigators hypothesize that robotic devices can enhance walking ability (e.g., speed, stride length) and reorganize joint kinematics. This study aims to quantify the effects of this treatment based on the level of impairment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of CP;
* able to walk independently with or without assistance

Exclusion Criteria:

* presence of behavioral problems;
* presence of uncontrolled seizures
* presence of severe visual disturbances.
Effectiveness of Quaker Complete Nutrition Supplements for Malnourished Adults

Intervention study in malnourished adults to assess whether a nutritional supplement given for 8 weeks in addition to the subject's usual diet improves body weight, body composition, biochemical and immune parameters.

Criteria to be included in this study include:

BMI (Body Mass Index) under 19 Free of cancer, HIV/AIDS, bulimia/anorexia and any malabsorption disorders

Description:

We are studying whether adding nutritional shakes will help participants gain weight and improve their health and immunity. This study lasts about 8 weeks and has a total of 7 visits.

Eligibility Criteria:
Inclusion Criteria:

* BMI (Body Mass Index) under 19
* Adult

Exclusion Criteria:

* HIV/AIDS
* Cancer
* malabsorption disorder
Psychosocial Issues in Insulin Pump Therapy in Children With Type 1 Diabetes Mellitus (DM)

The effect of change in diabetes treatment from multiple daily insulin injection therapy to continuous subcutaneous insulin infusion on psychosocial outcome measures (quality of life, diabetes burden, parents stress level, fear, family conflicts) in families with children and adolescents with diabetes mellitus type 1 have been analysed. Additionally the effect on metabolic parameters (HbA1c, severe Hypoglycemia, Ketoacidosis) have been analysed.

Children and adolescents currently treated with MDI and with an indication for CSII were randomized 1:1 to either starting with CSII as soon as possible or to continuing MDI while waiting six months for transmission to CSII, stratified by center. The primary outcomes were patient-reported diabetes-specific health-related quality of life , and diabetes burden of the main caregiver. We also investigated the impact of CSII on main caregiver stress, psychological well-being, fear of hypoglycemia, main caregiver's and adolescent's treatment satisfaction, family conflict, and HbA1c.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 DM
* Transition to Continuous Subcutaneous Insulin Infusion (CSII)
* meeting the costs by health services
* sufficient German literacy

Exclusion Criteria:

* Remission (diabetes duration \< 6 months, insulin \< 0.5 i.E./kg)
* severe learning problems
* Investigator's children
* Waiting time not advised for medical reasons
Paediatric Use of the Abbott Sensor Based Glucose Monitoring System

Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by children with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age 4-17 years (inclusive).
* Have type 1 or type 2 diabetes using insulin administered by injections or continuous subcutaneous insulin infusion (CSII).
* Currently testing blood glucose levels at least twice per day.
* Each participant has an identified Caregiver aged ≥18 years.
* In the investigator's opinion, technically capable of using device (participant and/or caregiver).

Exclusion Criteria:

* Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition.
* Currently prescribed oral steroid therapy for any acute or chronic condition.
* Currently receiving dialysis treatment or planning to receive dialysis during the study.
* Female participant known to be pregnant.
* Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management.
* Currently using a real-time or professional use continuous glucose monitoring (CGM) or FreeStyle Libre device or is planning to use one during the study, and unwilling to stop use of the device during the study.
* Known (or suspected) allergy to medical grade adhesives.
* In the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered).
Perceptions of Undergraduate Students and Teaching Staff on Online Teaching

Spread of COVID-19 in the world has led to a shift in teaching and learning techniques to online methods in order to prevent transmission of the disease. Misr International University (MIU) has an established online learning system that has been used together with face-to-face classes. The aim of this study is to assess and compare the satisfaction and perceptions of full-time teaching staff and undergraduate students regarding online learning during COVID-19 crisis.

Statement of the problem: Spread of COVID-19 in the world has led to a shift in teaching and learning techniques to online methods in order to prevent transmission of the disease. Misr International University (MIU) has an established online learning system that has been used together with face-to-face classes. However, shifting all courses in all the faculties to the online mode is a new experience that needs to be assessed to allow for future improvement plans.

Aim: To assess and compare the satisfaction and perceptions of full-time teaching staff and undergraduate students regarding online learning during COVID-19 crisis.

Method: An online anonymous questionnaire will be distributed to all Misr International University (MIU) students and staff members. The total number of students is 8679 and the total number of staff members regardless of their academic title is 530. The questionnaire will be validated by three experts and piloting will be performed on a sample of participants. The questionnaire consists of five sections: Demographics, satisfaction with online teaching and learning methods, knowledge, and perception of COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* All MIU undergraduate students and full-time staff members

Exclusion Criteria:

* Students or full-time staff members who will not respond to the questionnaire