cyrilzakka/clinical-trials huggingface dataset:
A Trial of SHR-1701 in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Pancreatic Cancer

The study is being conducted to evaluate the efficacy, safety and tolerability of SHR-1701 in combination with gemcitabine and albumin paclitaxel in first-line treatment of subjects with advanced/metastatic pancreatic cancer, and determine the RP2D for SHR-1701 in the combined regimen.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged between 18 and 70 years;
* Life expectancy ≥ 12 weeks judged by the investigator.
* The ECOG performance status was 0-1.
* At least 1 measurable lesion conforming to RECIST 1.1 criteria.
* In subjects with histologically or cytologically confirmed pancreatic cancer, there was evidence of inoperable locally advanced or distant metastases.
* Adequate organ and bone marrow function.
* Female subjects of childbearing age must undergo a serum pregnancy test within 7 days before the commencement of the study and the results are negative, and are willing to use a medically approved high potency contraceptive method during the study period and within 3 months after the last administration of the study drug; For male subjects whose partner is a female of childbearing age, they should be surgically sterilized or agree to use an effective method of contraception during the study period and for 3 months after administration of the last study.
* Willing to consent and signed the informed consent, and able comply with the planned visit, research treatment, laboratory examination and other test procedures.

Exclusion Criteria:

* Known allergy to the study drug or any of its excipients; Or had a serious allergic reaction to other monoclonal antibodies.
* Previous exposure to drugs/antibodies acting on T cell co-stimulation or checkpoint pathways.
* Major surgery within 28 days before the first experimental treatment (biopsy required for diagnosis is permitted).
* Subject with central nervous system (CNS) metastases.
* Had other active malignant tumors within 5 years before entering the study. Except for basal cell or squamous cell carcinomas, superficial bladder carcinomas, carcinoma in situ of the cervix, ductal carcinoma in situ, and papillary carcinoma of the thyroid, which may be treated locally and have been cured.
* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis.
* The presence of clinically significant acute or chronic pancreatitis.
* The presence of other acute or chronic infections of clinically significant significance.
* History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Ischemic Conditioning Chronic Stroke Study

Stroke is the leading cause of disability in adults in the United States. Despite advances in hyperacute stroke care, advancements in stroke rehabilitation are lagging. We have previously shown that a non-invasive, cost-effective, easy to perform intervention, called ischemic conditioning (IC), can improve paretic leg strength, reduce muscle fatigue, and increase walking speed in chronic stroke survivors (\>1 year post-stroke). The IC procedure makes the paretic leg transiently ischemic (5 minutes) using a cuff inflated to 225 mmHg, and repeats the occlusion 5 times with 5 minute periods of rest between cycles (45 total minutes). It is well accepted that the response to IC is complex and involves local, humoral and neural factors. The mechanism by which IC can confer motor benefit in stroke survivors is unknown. The aim of this study is to examine if IC can increase sympathetic nervous system (SNS) activity, which would promote an increased cardiovascular response to exercise and increased muscle strength. We hypothesize that plasma epinephrine and norepinephrine levels will increase more during a cold pressor test (a well-tolerated test to induce a sympathetic response) in chronic stroke survivors who undergo a single session of IC vs. IC-Sham. To accomplish the goals of this study, 15 chronic stroke survivors will each make two visits to the adult translational research unit at Medical College of Wisconsin (MCW) to have either IC or IC-Sham performed on their paretic leg in a counterbalanced order. Venous blood will be drawn before and after the IC or IC-Sham procedure and after a two-minute cold pressor test where the study participants submerge their hand into a bucket of ice water. This will cause an increased sympathetic response, which will be assessed by measuring blood pressure and the relative increase in the levels of circulating catecholamines (epinephrine and norepinephrine, assessed by high performance liquid chromatography).


Eligibility Criteria:
Inclusion Criteria:

* Study participants must be between 18-85 years of age, able to give informed consent, \>1 year post diagnosis of unilateral cortical or sub-cortical stroke, have residual lower limb paresis.

Exclusion Criteria:

* History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. wounds in the leg), chronic pain syndrome, history of head trauma, comorbid neurological disorder, any uncontrolled hypertension (\>160/100 mmHg), peripheral vascular disease, a myocardial infarction in the previous year, inability to follow 2 step commands, or history of multiple strokes.
Virtual Reality in Aphasia Telerehabilitation

The main purpose of this study is to evaluate the use of the immersive 3D HMD VR technology in the language intervention with a home-based telerehabilitation approach for people with aphasia. The assessments will be conducted at the baseline (prior the intervention periods) and after each intervention period (i.e. after the VR-intervention period and the waitlist period).

The purpose of the present project is to study the effects, feasibility, and the participants' experiences of this novel kind of language intervention. The effects of the intervention will be studied with various outcome measures in terms of language performance, functional communication, and quality of life. The aim is to explore the VR-intervention on the group level and with a randomized waitlist control group design (or delayed crossover design). In this study, the people with aphasia will be practicing at their home with support of their relatives, and participants will also receive regular remote guidance by a speech and language therapist (SLT) during the intervention. The relatives are also involved in the assessment process.

Eligibility Criteria:
Inclusion Criteria:

* Post-stroke aphasia ≥ 3 months from stroke
* Age 18-75 years
* Finnish as a native language
* Relative have the motivation and willingness to support person with aphasia in rehabilitation process
* At least some level of spoken output
* Moderate-to-severe aphasia
* Deficit in a word retrieval process

Exclusion Criteria:

* Participation in other intervention study during the study
* Participation in other traditional speech and language therapy during the VR-intervention (i.e. 9-10 weeks period).
* Severe and current psychotic disorder
* Dementia/other neurodegenerative disease
* History of previous stroke (/strokes) if not recovered, excluding TIAs (the criteria for the recovery: no residual aphasia or other disabilities caused by stroke which would affect in significant manner on everyday life)
* Active epilepsy / migraine (\< 3 years)
* Severe apraxia of speech
* Inability to act according to given instruction
* Severe neuropsychological disorder or the decline of cognitive / memory functions, which would significantly affect for training during the VR-intervention
* Vision or hearing impairment which would prevent the use of VR HMD
* if the participant's treatment or medication is unsuitable with the use of VR HMD device as assessed by the physician
* if the participant has the pacemaker or implantable (electric) medical device
Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients

Researchers are trying to determine the best course of action regarding the dietary management with a diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP diet) for irritable bowel syndrome.

An analysis of different educational programs providing information on the low FODMAP diet will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18-75 years) seen in the primary care clinic or in the Gastroenterology clinic at Mayo Clinic Florida, who are diagnosed with IBS by Rome IV criteria

Exclusion Criteria:

* Subjects who have previously tried the low FODMAP diet (whether successful or not)
* Current or recent (less than 4 weeks) opioid use
* Current or recent (less than 10 weeks) rifaximin use
* Inability to speak or read English
* Pregnancy and/or breast-feeding
* Medical or psychological issues that would prevent modifying their diet for 8 weeks.
Pulmonary Function at High-Altitude

Based on the findings of decreased vital capacity, decreased FEV1 and increased closing volume after ascent to high altitude, some investigators suggest the presence of a subclinical high altitude pulmonary edema (HAPE). Since these parameters are only indirect measures of pulmonary interstitial fluid accumulation, the aim of this study is to examine the effects of broncho-constriction on the increase of closing volume by extensive lung function testing in healthy mountaineers at low altitude and on the Margherita Hut (4559 m). As has been done in earlier studies, conventional thorax radiographs are used for verification of HAPE. In this study, the determination of the thoracic fluid quantity will be completed by measurements of thoracic impedance. In addition markers of pulmonary endothelial function will be assessed to get further insight into the regulation of pulmonary vascular tone at altitude and in particular into the pathophysiology of HAPE.


Eligibility Criteria:
Inclusion Criteria:

* Mountaineering ability required for reaching the Margherita hut (4559 m)

Exclusion Criteria:

* Borne above 1500 m
* Subjects with internal medical diseases like all cardiac diseases, all pulmonary diseases, Diabetes mellitus, infectious diseases, thyroid diseases, malignant diseases, hepatic or renal diseases,
* (Known) hypersensitivity to salbutamol or to another component of sultanol® or lidocaine, or to another component of xylocain® pump spray
* Intake of drugs, especially nifedipine, acetazolamide and glucocorticoids or of drugs interacting with sultanol® or xylocain® pump spray
* Pregnancy
The Effect of Remote Ischemic Preconditioning on Ischemia/Reperfusion Injury in a Liver Transplant Recipient

Ischemia and reperfusion injury is unavoidable during a liver transplantation. Remote ischemic preconditioning, a safe and feasible method, has previously been shown to reduce ischemia and reperfusion injury. In the transplantation setting, focus of remote ischemic preconditioning has been on the donor. However, preconditioning of the recipient may be a better approach due to the mechanisms by which ischemic preconditioning protects against ischemia and reperfusion injury.

The aim of this randomised, double-blinded clinical trial is to biochemically assess the liver function after application of remote ischemic preconditioning on the recipient.

Background The use of solid organ transplantation, including liver transplantation, is the golden standard for many end-stage solid organ diseases. Ischemia and reperfusion injury is unavoidable during a liver transplantation. Remote ischemic preconditioning, a safe and feasible method, has previously been shown to reduce ischemia and reperfusion injury. This may have a similar effect in a liver transplantation setting. In the transplantation setting, focus of remote ischemic preconditioning has been on the donor. However, preconditioning of the recipient may be a better approach due to the mechanisms by which ischemic preconditioning protects against ischemia and reperfusion injury.

The aim of this randomised, double-blinded clinical trial is to biochemically assess the liver function after application of remote ischemic preconditioning on the recipient.

Methods 52 patients undergoing a liver transplantation, included in accordance to the inclusion criteria, will be allocated to an intervention group (rIC-group) and compared to a retrospective non-intervention control group (non-rIC group) consisting of 52 patients. Patients in the non-intervention group will also be included in accordance to the inclusion criteria. Within two hours before surgery, patients in the intervention group will be subjected to four rounds of five-minute inflations and five-minute deflations of a pneumatic tourniquet applied on the right leg.

Follow-up time will be 30 days.

Measurements The aim of this trial is to assess the effect of remote ischemic preconditioning on the extent of liver injury and inflammation as a result of ischemia and reperfusion injury. Assessment will be done by measurement of biomarkers relevant to liver function and liver injury.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing liver transplantation
* Patients aged 18 or above
* Patients who have given an informed consent

Exclusion Criteria:

* Patients undergoing re-transplantation.
* Patients who do not or cannot give an informed consent.
* Patients who have undergone surgery six weeks prior to liver transplantation.
* Patients with known peripheral vascular disease.
* Patients with an infection localized to the area of rIC-intervention
* Patients with at a high risk or with previous history of multiple thrombo-embolic diseases.
* Patients undergoing active immunosuppressive therapy
Clinical Trial to Reduce Sedentary Lifestyle in Patients with Type 2 Diabetes

The prevalence of diabetes has increased worldwide, making it the most prevalent metabolic disorder. Physical inactivity contributes to the progression of this disease and aggravates other comorbidities, such as obesity and cardiovascular disease. Beneficial strategies aimed at promotion and healthy aging, oriented to decrease sedentary behavior, are necessary to obtain desirable metabolic effects and improve the quality of life of people with diabetes.

The objective is to examine, through a clinical trial, the effect of decreasing sedentary time and increasing motivation to adopt an active lifestyle on different clinical, anthropometric and biochemical parameters in patients diagnosed with type 2 diabetes mellitus.

A clinical trial with a 12-month follow-up will be carried out. The study has been chosen to be conducted as a single-center study for strategic and logistical reasons. A two-arm parallel design will be used. The control group (CG) will receive messages by mail with healthy lifestyle habits, while the intervention group (IG) will receive a behavioral intervention based on lifestyle modification, focusing on reducing sedentary time. These interventions will be directed by the research nurse.

The general objective of the study is to know the effect of decreasing sedentary time and increasing motivation to adopt an active lifestyle of different health-related parameters in patients diagnosed with type 2 diabetes mellitus. Also to provide support and resources for the proper management of diabetes. Likewise, it will be verified that face-to-face interventions and telephone interventions by nursing professionals decrease the sedentary time in the diabetic population and if it means and improvement in clinical, anthropometric and biochemical parameters. Also, to evaluate the quality of life and the degree of motivation aimed at reducing sedentary time and to integrate the reduction of sedentary time in the lifestyle of the participants with practical tools and guidelines adapted to the circumstances.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus
* 18 years of age or older
* Minimal physical fitness

Exclusion Criteria:

* Medical contraindication
* Pregnant women
* Recent surgical interventions limiting mobility
* Patients currently undergoing oncological treatment or less than one year since the end of treatment.
* Suffering from dementia, impairment or a severe cognitive or psychiatric disorder.
Ulmus Macrocarpa Hance Extract and Lipid Profile

The investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the Ulmus Macrocarpa Hance extract on lipid profile in adults with dyslipidemia for 12 weeks.

Previous another our study have indicated that Ulmus Macrocarpa Hance extract (UMH) may have the ability to decrease blood cholesterol. Therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of the UMH on lipid profile in adults with dyslipidemia; the safety of the compound are also evaluate. The Investigators examine total cholesterol, HDL-cholesterol, triglyceridemia, LDL-cholesterol, and other biochemical parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty adults were administered either 500 mg of UMH or a placebo each day for 12 weeks;

Eligibility Criteria:
Inclusion Criteria:

* LDL cholesterol ranging from 130 to 190 mg/dL

Exclusion Criteria:

* Abnormal liver or renal function (i.e., serum aminotransferase activity \> 80 IU/L and serum creatinine concentrations \> 1.2 mg/dL)
* Diabetes (diagnosed clinically or fasting glucose level \> 126 mg/dL)
* History of ischemic heart disease or cerebrovascular disease
* Uncontrolled hypertension
* History of serious cardiac disease such as angina or myocardial infarction
* History of gastrectomy
* History of medication for psychiatric disease
* Administration of oriental medicine including herbs within the past 4 weeks
Differences in Timely Cancer Diagnosis in African American and Caucasian Patients With Newly Diagnosed Colorectal Cancer

RATIONALE: Gathering information about timely diagnosis in African American and Caucasian patients with newly diagnosed colorectal cancer may help doctors learn more about factors that influence a diagnosis and plan the best treatment.

PURPOSE: This phase I trial is studying differences in timely cancer diagnosis in African American patients and in Caucasian patients with newly diagnosed colorectal cancer.

OBJECTIVES:

* Identify and examine the factors that influence appraisal and diagnostic delay by focusing on recognition, perception, communication, and response to pre-diagnosis cancer symptoms in African American and Caucasian patients with newly diagnosed colorectal cancer.

OUTLINE: This is a multicenter study. Patients are stratified according to race (African-American vs Caucasian) and gender (male vs female).

Patients undergo a 45-60 minute interview to obtain information on variations in symptom perception, assessment, and patient-physician communication process. Patients are assessed by sociodemographic characteristics (i.e, education, gender, age, insurance status, employment status, income, race/ethnicity, and religiosity), information of close confidants (i.e., relationship, family history of cancer, and caregiver/decision-making status), and physician characteristics. Patients are also assessed by the Trust in the Health Care System, DMPQ, RCS, Brief COPE scale, Lukwago Religiosity scale, and RAND Social Support Survey questionnaires.

Patient charts are reviewed to obtain medical data.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older
* Cognitively able to participate in an interview
* Diagnosed with Colorectal cancer
* Patient at University Hospitals, Case Western Reserve University, or Cleveland Clinic Foundation
* diagnosed within 6 months of the scheduled interview
* have no prior history of colon cancer or cancer of any other major organ system
* any stage of cancer
* Patient will have described their symptoms to their PCPs
* Patient will have acted as their own decision maker
* Must be African American or Caucasian

Exclusion Criteria

* No disease discovered by previous routine screening or by other unintentional detection procedure (i.e., without symptom appraisal process or communicating specific symptoms to physicians)
* Not living in nursing or assisted living facilities
* Cognitive impairment
NT-proBNP Levels During Triple Therapy With Formoterol/Glycopyrrolate/Budesonide in Patients With COPD.

Observational prospective study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the iniation of triple inhaled formoterol/glycopyrrolate/budesonide therapy.

The purpose of the trixeo study is to conduct a prospective observational study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the initiation of triple inhaled formoterol/glycopyrrolate/budesonide therapy.

Eligibility Criteria:
Inclusion Criteria:

* COPD;
* Clinical indication for triple inhalation therapy with formoterol/glycopyrrolate/budesonide;

Exclusion Criteria:

* Life expectancy less than one year;
Mesotherapy in the Treatment of Chronic Migraine

Mesotherapy is a type of injection frequently used in clinics. It is a treatment procedure that involves the injection of some drugs under the skin or into the skin. Mesotherapy is used in musculoskeletal system diseases, but it is reported that the effects of its use in migraine are uncertain.

Migraine is one of the types of headaches. For the diagnosis of chronic migraine, the headache must last more than 15 days. Nerve blocks, oral medication and neuromodulation are recommended for migraine treatment.Mesotherapy is a type of injection frequently used in clinics. It is a treatment procedure that involves the injection of some drugs under the skin or into the skin. Mesotherapy is used in musculoskeletal system diseases, but it is reported that the effects of its use in migraine are uncertain. This study was planned to show the effectiveness of mesotherapy in patients with migraine.

Eligibility Criteria:
Inclusion Criteria:

- Clinical diagnosis of chronic migraine disease

Exclusion Criteria:

* Infection disease
* Thyroid disease
* Anemia disease
* Systemic disease
Error Enhancement of the Velocity Component

The purpose of this pilot study was to explore the impact of enhancement of the velocity component error in the course of reaching movements of the impaired/hemiparetic limb in an acute stroke subject. We hypothesized that the method would shift velocity profiles toward the optimal, resulting in a reduction in error. A prototype robot. This robotic device system has a two-dimensional motor, basic measurement capacities, and a robotic arm which is engaged to the subject's upper-limb in a sitting position.

The enhancement of the velocity component error would shift velocity profiles toward the optimal, resulting in a reduction in error.

The wrist of the subject is connected to the robotic arm by a strip which supports the arm but allows free movements of the wrist. This configuration allows subjects with impaired grasping ability to use the system. A bio-feedback system enables the subject to perform various functional motor tasks that are presented on the screen in front of him. The system's sensors detect motor errors or deviations from an optimal/proper movement trajectory or velocity profile. Any deviation in direction, velocity, acceleration or necessary force from the optimal trajectory results in applied robotic forces that enhance such errors/deviations. The sensors and the applied forces all work and compute in real time, so that the force measurements and the applied force are updated to the executed movement.

Eligibility Criteria:
Inclusion Criteria:

* Single stroke
* Two to three weeks post Stroke
* Able to understand simple commands
* Able to perform some reaching movements with the affected arm.
* No other neurological, neuromuscular, orthopedic disorders and visual deficit

Exclusion Criteria:

* Perceptual, apraxic, or major cognitive deficits,
* Shoulder joint subluxation or pain in the upper-limb, and
* Spasticity \> 1 (single muscle Modified Ashworth Scale).