cyrilzakka/clinical-trials huggingface dataset:
Tolerance and Acceptability Evaluation of AYMES AMSTERDAM

To evaluate tolerance and acceptability of 'AMSTERDAM' in patients requiring supplementary oral nutritional support compared with currently available alternatives.

To evaluate tolerance and acceptability of 'AMSTERDAM' in patients requiring supplementary oral nutritional support compared with currently available alternatives, measuring outcomes of GI effects, Compliance, product preference, convenience etc.

To obtain data to support an ACBS submissions for 'AMSTERDAM' (to allow for prescription in the community at NHS expense).

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants.
* ≥ 18 years of age.
* Participants of the intended target group (e.g. MUST score ≥ 1) with an anticipated period of nutritional support ≥ 7 days.
* Patient is able and willing to provide written informed consent.

Exclusion Criteria:

* Participants with medical or dietary contraindication to any feed ingredients.
* Participants requiring sole enteral tube feeding or parenteral nutrition.
* Participants with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis.)
* Participants with dysphagia requiring levels 1, 2, 3 or 4 thickened fluids.
* Participants with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
* Participants for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements.
* Participation in any other studies involving investigational or marketed products concomitantly or within 2 weeks prior to entry into the study.
TXA in the EMS on the Helicopter and the Ambulance

Coagulopathy in trauma increases mortality and morbidity. Early administration of tranexamic acid (TXA) seems to improve survival and outcome. Thus this study evaluates the administration of TXA on scene by the emergency medical services (EMS) or by the crew of a rescue helicopter in multiple trauma patients or isolated traumatic brain injury (TBI). Coagulopathy will be assessed by standard laboratory tests as well as thromboelastometry.

Coagulopathy in trauma increases mortality and morbidity. Early administration of tranexamic acid (TXA) seems to improve survival and outcome; this was shown partially by the CRASH2 study, where patients received TXA in the emergency room. Thus this study evaluates the administration of TXA on scene by the EMS or by the crew of a rescue helicopter in multiple trauma patients or isolated TBI. Coagulopathy will be assessed by standard laboratory tests as well as thromboelastometry in 50 patients. The results will be compared to a study published by Theusinger et al. (Changes in Coagulation in Standard Laboratory Tests and ROTEM in Trauma Patients Between On-Scene and Arrival in the Emergency Department.Theusinger OM et al. Anesth Analg. 2014 Dec 24. \[Epub ahead of print\] PMID: 25545751) where no TXA was administered on scene and only changes in coagulation between on scene and in the emergency department were assessed.

Eligibility Criteria:
Inclusion Criteria:

* multiple trauma
* traumatic brain injury

Exclusion Criteria:

* pregnant
* \< 18 years
* no TXA
* not speaking the german language
Prevalence of Sleep Disordered Breathing

A novel technique in identifying unspecified sleep apnea has been developed. This technique uses signals typical acquired from a bedside monitor that is found in critical care environments. Those signals are then processed by a sleep analysis algorithm to provide an Apnoea Hypopnea Index (AHI) score. This study is intended to determine whether the prevalence of sleep disordered breathing identification among patients in a Coronary Care Unit (CCU) using this novel approach is significantly different than using routine techniques.

This study will focus on inpatients diagnosed with coronary conditions. Specific eligibility criteria will include:

* Unstable angina
* Acute myocardial infarction
* Congestive heart failure Subjects enrolled in the study will be scored for sleep apnea using a novel approach designed by the sponsor. That score will not be used in the course of treatment. A follow-up call will determine whether the subject was identified for sleep disordered breathing during the hospital stay. A comparison will be done on the number of those identified with and without the use of the sleep scoring device.

Eligibility Criteria:
Inclusion Criteria:

* Age equal to or greater than 18 years at time of consent
* Written informed consent
* Patients admitted to the intensive care unit if able to remove oxygen
* Patients admitted to telemetry and step-down floor that will not require oxygen
* Primary diagnosis (any of the following)
* Un-stable angina
* Acute myocardial infarction
* Congestive heart failure

Exclusion Criteria:

* Previously diagnosed sleep disordered breathing
* Inability to consent
* Pregnancy
* Intubation (no longer excluded after extubation)
* Oxygen therapy (no longer excluded after therapy ends)
* End-Stage renal disease
* End-Stage liver disease
* Terminal disorders other than cardiac
* Severe scoliosis
* Cervical spinal cord injuries
* Neuromuscular disorders
* Severe COPD as defined by prescription of home oxygen therapy
* Other unsuitable circumstances
DeNovo NT Longitudinal Data Collection (LDC) Knee Study

The purpose of this study is to evaluate the long-term outcomes of DeNovo NT, a tissue product used for the repair of cartilage damage in the knee. This product has been on the market since 2007 and implanted in more than 10,000 patients around the country.

Knee cartilage injury is a major cause of pain and functional impairment in young to middle age adults, and can lead to progressive joint degeneration. Adult cartilage has little regenerative capacity and many of the current treatment options have limited or unknown durability. DeNovo NT is an allogeneic tissue graft, prepared from donated juvenile cartilage, which has been shown to have a higher chondrogenic potential than adult cartilage. The graft involves a single surgery with no need for scaffolds, flaps or donor-site morbidity. This study will follow the long-term outcomes and durability of DeNovo NT in patients grafted with this product in the knee, for up to five years. It will enroll subjects prospectively (at the time of surgery) and retrospectively (those who have been previously implanted). Data will be collected on patient-reported outcomes, results of knee examinations, and reoperations and revisions.

Eligibility Criteria:
Inclusion Criteria:

* Has a contained articular cartilage lesion(s) of the knee or Osteochondritis Dissecans OCD lesion(s) of the knee for which arthroscopic or surgical intervention is warranted, OR Has had prior treatment with DeNovo NT for a contained articulare cartilage lesion(so of the knee or Osteochondritis Dissecans OCD lesion(s) of the knee
* Has voluntarily signed the IRB approved Informed Consent
* Is of stable health and is able to undergo surgery
* Is male or female over the age of 18 years
* Is physically and mentally willing and able to comply with post-operative rehabilitation and routinely scheduled clinical visits

Exclusion Criteria:

* Displays a high surgical risk as determined by the investigative surgeon
* Is pregnant or breast-feeding
* Has a clinically diagnosed autoimmune disease
* Has an active joint infection or history of chronic joint infection at the surgical site
* Has damage to the subchondral bone that has not/will not be repaired prior to DeNovo NT treatment
Outcomes Study of Hyperinsulinemic Glucose Control in Cardiac Surgery

Patients undergoing cardiac surgery will be randomized into one of two groups. Group A will be administered insulin using the hyperinsulinemic-normoglycemic clamp to normalize blood glucose levels intra-operatively. Group B will be administered insulin at the standard of care levels established by the participating institution. Patients will be followed at 10 days, 15 days and one year post-operatively.

Using a randomized, controlled design, we propose to test the primary hypothesis that normalization of blood glucose using a hyperinsulinemic-normoglycemic clamp technique reduces the risk of a composite outcome (one or more) of 30-day postoperative mortality and serious postoperative cardiac, renal, neurologic, and infectious postoperative complications in patients undergoing cardiac surgery.

Our secondary hypothesis is that hyperinsulinemic normoglycemic therapy will reduce length of stay in intensive care unit, atrial dysrhythmias, creatinine elevation, hospital readmission, all-cause and cardiac one-year mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-90 years old
* Scheduled for cardiac surgery requiring cardiopulmonary bypass

Exclusion Criteria:

* Off-pump surgical procedures
* Anticipated deep hypothermic circulatory arrest
* In available, baseline cardiac troponin I (\>0.5 ng/L) or troponin T (\> 0.1 ng/mL) levels (at RVH or CC, respectively)
* Any contraindications to the proposed interventions
* Active infection, including patients with endocarditis or infected pacemaker leads.
* Any infection requiring long- term antibiotics ( \> 14 days)
* kidney disease requiring renal replacement therapy
Reducing Dietary Added-Sugar Consumption During the Transition to College

The goal of this cluster randomized controlled trial was to compare the effects of two single-session interventions (sugar-intensive vs. general health control) on added sugar intake, motivation to reduce sugar consumption, and factual knowledge about added sugar 6 weeks later, in a sample of first-semester undergraduates.

Excessive sugar consumption is recognized as a critical public health concern. For many young adults, the transition to college presents both risk and a promising opportunity to encourage formation of healthy dietary habits. Capitalizing on this window of opportunity, we conducted a cluster-randomized controlled trial to compare the effects of two single-session interventions on added sugar intake in a sample of first-semester undergraduates. Participants received either an intervention primarily focused on reducing added sugar consumption or a general health behavior intervention with units on physical activity, sleep, and healthy diet. Participants' added sugar intake, motivation to reduce sugar consumption, and factual knowledge about added sugar intake were compared at follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Students aged 18 years and older, enrolled in online sections of a required transition-to-college course at a large public university in the Southwest region of the U.S. All students in online sections of this class received the single-session intervention during their normal class period, early in the Fall 2020 semester, and were eligible to participate.

Exclusion Criteria:

* Age \< 18 years.
Dose-Escalation, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GB-6002 Local Infiltration in Healthy Male Adults

This study is to evaluate the safety and tolerability of single dose of GB-6002 (Ropivacaine) Local Infiltration in healthy male Adults. And, It is to compare pharmacokinetic characteristics of GB-6002 single dose injection with active comparator.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males,19 to 55 years of age, inclusive at the time of screening visit.
* At the time of screening, those with a body weight of 55 kg or more and a BMI (Body Mass Index) within 18.0 to 27.0 kg/m², inclusive.
* Subjects who do not have plans to receive COVID-19(coronavirus disease 2019) vaccination during the clinical trial starting from 14 days prior to the first administration of investigational drug.
* Subjects who have understood the purpose of this clinical trial, voluntarily chosen to participate, and provided written consent to adhere to the restrictions.

Exclusion Criteria:

* Subjects with clinically significant cardiovascular, respiratory, hepatic, renal, neurological, endocrine, hematologic, oncological, psychiatric, or urological conditions, or a history related to such conditions.
* Subjects with systolic blood pressure less than 90 mmHg or greater than 150 mmHg, or diastolic blood pressure less than 50 mmHg or greater than 100 mmHg during the screening assessments.
* Subjects who exhibited clinically significant abnormalities in physical examination, clinical laboratory tests, or electrocardiograms during the screening assessments.
* Subjects known to be hypersensitive to Investigational Product and its components.
* Subjects who have continued to drink alcohol within 1 month prior to the first administration of Investigational Product or who are unable to abstain from alcohol during the clinical trial.
* Subjects who smoked continuously within 1 month prior to the first administration of Investigational Product or are unable to quit smoking during the clinical trial.
* Subjects who has taken drugs that induce or inhibit drug metabolism enzymes, such as barbiturates, within 1 month prior to the first administration of Investigational Product.
GALLEX 9: Safety and Tolerability of Oral Tesaglitazar When Added to Insulin Therapy in Patients With Type 2 Diabetes

This is a 140-week open-label, multi-center long-term extension study from GALLANT 9 to monitor the safety and tolerability of oral tesaglitazar 0.5 mg and insulin in patients with type 2 diabetes during up to 140 weeks of treatment. The total duration, including treatment and follow-up, is 143 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Provision of a written informed consent
* Men or women who are \>= 18 years of age
* Female patients: postmenopausal; hysterectomized; or, if of childbearing potential, using a reliable method of birth control.
* Completed the last two visits of the randomized treatment period in GALLANT 9

Exclusion Criteria:

* Type 1 diabetes
* New York Heart Association heart failure Class III or IV
* Treatment with chronic insulin
* History of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like Actos or Avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin)
* History of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, or neutropenia (low white blood cells)
* Creatinine levels of above twice the normal range
* Creatine kinase of above 3 times the upper limit of normal
* Previous enrollment in this long-term extension study
* Any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram which, in the judgment of the investigator, would compromise the patient's safety or successful participation in the clinical study
Design of an Affordable Gym for Post Stroke Rehabilitation

Rehab in a Crate is a therapy gym designed to be affordable, compact and easily transportable. The purpose of this particular study is to gain feedback on the initial design of the Rehab in a Crate system. This will be accomplished by using qualitative ethnographic research methods (i.e. human centered design) in the form of surveys that have been carefully designed by members of the research team. The eligibility criteria of this survey research reflects the intended user base of an eventual finished product, which is survivors of stroke and cerebral palsy across the globe. And while healthcare professionals are not the user base per se, their expertise and feedback should be instrumental in the design of future iterations of the Rehab in a Crate. Ease of use, utility, design, and various features, both existing and intended, will all be surveyed items.

The investigators aim to survey stroke survivors and healthcare professionals on the design, ease of use, utility, and various features of, both existing and those yet-to-be-developed. This feedback will help to fine tune further development of this therapy gym, Rehab in a Crate, and move forward in the iteration process.

Note: The device is not being used at this moment for diagnostic or evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Stroke survivors who are more than 3 months post stroke and persons with cerebral palsy adults - have hemiplegia or diplegia
* Health professionals who have considerable experience in stroke rehabilitation.

Exclusion Criteria:

* Anyone who is not 18 years of age.
* More than mild spasticity in the upper of lower extremities.
* A cognitive score on the Montreal Cognitive Assessment that indicates that the participant is cognitively impaired.
* Motor impairment that precludes interaction with the Rehab in a Crate (e.g. unable to grip a handle).
3D vs 2D HD Laparoscopy in Inguinal Hernia Repair

Inguinal hernia can be repaired laparoscopically. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. The three-dimensional laparoscopic systems are gradually entering the operating rooms. There are plenty of evidence of the benefits of 3D-system in laboratory conditions. However, no prospective randomized trials have been published in the clinical point of view. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system in the transabdominal pre-peritoneal (TAPP) inguinal hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for laparoscopic inguinal hernia repair

Exclusion Criteria:

* Some other surgical operation planned during TAPP
* Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis)
* Operating surgeon experience less than 5 3D laparoscopy operations
Use of Baricitenib to Maintain of Remission

Baricitinib a selective Janus kinase (JAK) inhibitors 1\&2 have been recognized as a potential therapeutic option in systemic lupus (SLE), also known Baricitinib, a JAK inhibitor, has demonstrated efficacy and safety in the treatment of dermatitis and arthritis 1 ; however, no JAK inhibitor studies have been conducted in lupus nephritis (LN) maintain remission to date.

Baricitinib a selective Janus kinase (JAK) inhibitors 1\&2 have been recognized as a potential therapeutic option in systemic lupus (SLE), also known Baricitinib, a JAK inhibitor, has demonstrated efficacy and safety in the treatment of dermatitis and arthritis 1 ; however, no JAK inhibitor studies have been conducted in lupus nephritis (LN) maintain remission to date. Objectives: To assess the efficacy and safety of Baricitinib in patients (pts) with LN by dose 4mg versus 2 mg versus MMF 1 gm daily dose.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Lupus nephritis Disease
* Must be able to swallow tablets
* lupus nephritis in remission

Exclusion Criteria:

* antiphospholipid syndrome disease
* thrombosis history
* sever anemia, leukopenia or thrombocytopenia
* impaired liver and renal function
Tirellizumab+Anlotinib VS Anlotinib for MSS-type CRC

To compare the efficacy and safety of tirellizumab combined with anlotinib in the treatment of mss colorectal cancer. To investigate the effective biomarker of anlotinib combined with tiralizumab

This was a multicenter retrospective cohort study to compare the efficacy of tyrosine kinase inhibitor（TKI） combined with immune checkpoint inhibitors(ICIs) versus tyrosine kinase inhibitor alone in the treatment of advanced MSS colorectal cancer. Patients with MSS CRC who have been confirmed by pathology and have relapsed or failed multiline therapy were included in the study. Patients who had received tirellizumab plus anlotinib were considered the combination group, and those treated with anlotinib were classified as the monotherapy group. The efficacy and safety of the two regimens were compared. At the same time, Whole-exome sequencing and transcriptome sequencing were performed on the patients in the response and non-response groups of the combination group to reveal the characteristics of their microenvironment and search for biomarkers related to response.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* Patients with mss colorectal cancer who have been confirmed by pathology and have relapsed or failed multiline therapy
* Patients who have been treated with anlotinib monotherapy(12 mg qd, d1-14; 21 days per cycle) or anlotinib(12 mg qd, d1-14; 21 days per cycle)+ tislelizumab(200 mg, once every 3 weeks)
* the presence of at least one measurable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Exclusion Criteria:

* Patients with other malignant tumors
* Prior treatment with antirotinib, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibody or drug that specifically targets T cell co-stimulation or checkpoint pathways
* Follow-up was less than 30 days
Perception of Illness Turkish Validity and Reliability Study

In chronic diseases such as rheumatic diseases, it is important to direct the treatment of the disease and to evaluate the disease perception in terms of the course of the disease. As a result of this study, this questionnaire, which will help us gain information about the perception of the disease specific to rheumatic diseases, will be translated into Turkish.

Disease perception is the cognitive aspect of the disease state. Although they experience the same disease in a certain period of their lives, the methods of meeting the disease and coping with the disease differ. Patients try to explain their illnesses in the light of their personal experiences, knowledge, values, beliefs and needs. People create cognitive models to explain and predict events in the outside world. Patients also develop similar patterns of symptoms of transient or long-term disease. Leventhal et al. suggested that patients formed their own coping mechanisms with these cognitive models and developed the self-regulation theory. According to this theory, people create schemas about illness and life-threatening situations in their minds with the information presented to them from concrete and abstract sources. These cognitive models also include beliefs about treatment and control of the condition.

The World Health Organization (WHO) has classified more than 200 musculoskeletal diseases, the most common being rheumatoid arthritis and osteoarthritis. The biopsychosocial model has been drawing attention in rheumatological rehabilitation in recent years. This model acknowledges that the experiences and symptoms of the disease are affected by biological, psychological and social factors. The dysfunction is not only related to the severity of the disease, but also to how the disease is perceived. The patient's beliefs and perceptions about his illness show how the illness affects him both physically and emotionally. Disease perception is based not only on symptoms but also on disease-related consequences, concerns, and past illness experiences of the patient. Recent studies emphasize the importance of disease perception in explaining the difference in treatment outcomes in chronic diseases, including rheumatic diseases.

It was planned to determine the validity and reliability of the Disease Perception Scale in Rheumatic Diseases due to the importance of treatment in rheumatic diseases and the evaluation of disease perception in terms of the course of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer.
* To be diagnosed with any of the rheumatic diseases (Rheumatoid Arthritis, Spondyloarthropathies, Fibromyalgia, Reactive Arthritis, Sjögren Syndrome, Systemic Lupus Erythematosus) by a specialist.

Exclusion Criteria:

* Being diagnosed with a chronic disease other than rheumatic disease that requires regular medication.