cyrilzakka/clinical-trials huggingface dataset:
Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture

The objective of this trial will be to establish whether the ultrasound-guided suprainguinal fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture from delirium as compared to placebo

Geriatric patients suffer from hip fractures very often. Delirium is a perioperative neuropsychiatric complication that is characterized by sudden change of mental status, inattention, disorientation and memory impairment with fluctuations of symptoms during the day. Delirium causes increased morbidity and mortality, decreased postoperative functional activity and may predispose to dementia.

Perioperative pain may be an important predisposing factor to delirium. Intravenous opioids have been widely used to relieve patients with hip fracture from pain, but they have a lot of complications and have been correlated with delirium as well. Fascia Iliaca compartment block is a peripheral compartment nerve block that is used in hip surgeries. Use of this compartment nerve block to protect geriatric patients from delirium has not been studied.

The objective of this trial will be to establish whether the ultrasound-guided suprainguinal fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture from delirium as compared to placebo

Eligibility Criteria:
Inclusion Criteria:

* geriatric patients
* American Society of Anesthesiologists (ASA) I-III
* hip fracture patients

Exclusion Criteria:

* dementia
* communication or language barriers
* patients with nutritional problems
* bedridden patients
Effect of Pursed-Lip Breathing on Blood Pressure and Heart Rate

Hypertensive urgency (HT urgency) is an alarm sign of uncontrolled hypertension. It can be aggravated by nonadherent to medication and psychosocial stress. Mindfulness is beneficial for reducing stress, while deep and slow breathing is effective for blood pressure (BP) lowering. The objective of the study was to assess the effect of pursed-lip breathing with number counting (PLB with NC) that promotes mindfulness and a deep/slow breathing pattern on BP and heart rate (HR) in the HT urgency patients.

This was a single-blinded randomized controlled trial. Patients aged between 18-80 years old, diagnosed with HT urgency, who presented at the emergency room of Srinagarind hospital (a 1000-bed, tertiary-care level university hospital), Khon Kaen University between September 1st, 2019 to June 30th, 2020, were enrolled. Those with cardiac arrhythmias, acute HF, acute coronary syndromes, acute stroke, acute respiratory failure, alteration of consciousness, and pregnant women were excluded. This study was approved by the Khon Kaen University Ethical Review Board in Human Research (HE611586). All patients gave their written informed consent before the enrollment.HT urgency was defined as SBP \>180 mmHg and/or DBP \>110 mmHg without any signs or symptoms of target organ damages.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years old patients who diagnosed with HT urgency, who presented at the emergency room

Exclusion Criteria:

* Patients with cardiac arrhythmias,
* Acute heart failure
* Acute coronary syndromes
* Acute stroke
* Acute respiratory failure
* Alteration of consciousness
* Pregnant women
Efficacy of Duloxetine Compared to NSIADs in Osteoarthritis of Knee

Osteoarthritis (OA) is the most common degenerative joint disease, affecting more than 25% of the population . Knee OA is an insidious disease related to structural changes in the joint over many years. Progressive articular damage results in a loss of the extracellular matrix of cartilage in addition to changes in subchondral bone.

Duloxetine, a selective serotonin, and norepinephrine reuptake inhibitor, it seems to be effective in treating neuropathic and chronic pain conditions.

This will be a 13-week A randomized open labelled clinical trail in Iraqi Kurdistan Region, that will be designed to assess the efficacy of duloxetine tablet compared with other group (Nonsteroidal anti-inflammatory) drug on the reduction of pain caused by osteoarthritis of the knee.

Patients will be divided into two groups, first group (case) will receive duloxetine tablet 30mg for two weeks then titrated up to duloxetine 30mg BID. Patients will be instructed to take the medication with meals. Patients will be observed at visits (0) baseline then at second visits at 13 weeks then will be compared to control group that will receive NSAID (nonsteroidal anti-inflammatory drug) at baseline (0) visit then 2nd visits at 13 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. \> 40years of age
2. both Genders
3. who will meet the American College of Rheumatology clinical and radiographic criteria for the diagnosis of osteoarthritis of the knee
4. with pain for ≥14days of each separate month for 3months before study entry, with a mean score ≥4 on the 24-h average pain score (0-10) using the average of daily ratings

Exclusion Criteria:

1. if they have diagnosed with inflammatory arthritis or an autoimmune disease
2. if they received invasive therapy in last 3 months (knee arthroscopy) or knee replacement at any time
3. patients with psychiatric disorders
4. Hypertension
5. Heart disease
6. patients on antipsychotics or anti-depressant -
A Study of PRT543 in Participants With Advanced Solid Tumors and Hematologic Malignancies

This is a Phase 1 cohort, dose-escalation, dose-expansion study of PRT543 in patients with advanced cancers who have exhausted available treatment options. The purpose of this study is to define a safe dose and schedule to be used in subsequent development of PRT543.

This is a multicenter, open-label, sequential-cohort, dose-escalation, dose-expansion Phase 1 study of PRT543 in patients with advanced cancers who have exhausted available treatment options. Enrollment will take place concurrently into two distinct patient groups (one for solid tumors/lymphomas and one for hematological malignancies). The study will consist of 2 parts, a dose escalation part, and once the recommended phase 2 dose (RP2D) has been determined, a cohort expansion part involving up to ten separate cohorts. For patients, the study will include a screening phase, a treatment phase, and a post treatment follow-up phase. An end-of-study visit will be conducted within 30 days after the last dose of PRT543.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic or advanced solid tumor; or advanced diffuse large B-cell lymphoma; or advanced mantle cell lymphoma; or relapsed myelodysplastic syndrome, acute myeloid leukemia or chronic myelomonocytic leukemia; or relapsed myelofibrosis. All malignancies must be refractory to established therapies
* Biomarker-selected solid tumors
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
* Adequate organ function (bone marrow, hepatic, renal, cardiovascular)
* Female patients of childbearing potential must have a negative pregnancy test within 7 days of the start of treatment and must agree to use an effective method of contraception during the trial

Exclusion Criteria:

* Primary malignancies of the Central Nervous System(CNS) or uncontrolled CNS metastases
* Requirement of pharmacologic doses of glucocorticoids
* Prior treatment with chimeric antigen receptor T cells (CAR-T cells)
* HIV positive; known active hepatitis B or C
* Known hypersensitivity to any of the components of PRT543
* Prior allogeneic bone marrow transplant; autologous hematopoietic transplantation less than 100 days since transplantation
COVID-19 Vaccination in Rheumatic Disease Patients

The research is being done to study the immune responses to COVID-19 vaccination in patients with rheumatic diseases.

Because patients treated with immunosuppressive agents have been excluded from initial clinical trials, and most patients with rheumatic diseases are taking immunosuppressants, the immune responses towards the mRNA COVID19 vaccines in these patients remains unknown. The goal is to study the immune response to COVID-19 vaccination in patients with rheumatic diseases. Blood samples collected before and longitudinally after mRNA-based COVID-19 vaccination (i.e., Pfizer and Moderna vaccines) will enable detailed immunological investigation of the interaction between COVID-19 vaccination and rheumatic diseases. These efforts will provide novel insights into the COVID-19 vaccine response in patients with rheumatic diseases, and eventually would inform clinical management to improve patient care.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatologist confirmed diagnosis of one of the following diagnoses:
* Systemic lupus erythematosus;
* Sjogren syndrome;
* Inflammatory myositis;
* Psoriatic arthritis;
* Osteoarthritis;
* Gout;
* Ankylosing spondylitis;
* IBD-related arthritis.

Exclusion Criteria:

* Active infection or untreated malignancy (other than skin cancer) at enrollment.
* Pregnancy
Efficacy of Omega-3 as Adjunctive Therapy for Medically Intractable Epilepsy: A Prospective Open-label Pilot Study

The purpose of this study is to determine whether omega-3 is effective in the treatment of medically intractable epilepsy as adjunctive therapy.

This study will enroll total 30 patients with medically intractable epilepsy. The patients will be fully assessed on the enrollment, and then seizure frequency will be counted for three months without changing medication. After three months, Omega-3 will be administered for next three months. Seizure frequency, questionnaires evaluating mood and QOL, and adverse events are evaluated at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients with medically intractable, focal or generalized, epilepsy: Patients with localization-related partial onset or generalized tonic/clonic seizure according to the International League Against Epilepsy (ILAE) can be included. Medically intractable epilepsy means that recurrent seizures occur even though two or more anti-epileptic drugs have been used appropriately for over one year.
* Seizure frequency criteria: three seizures per one month for recent 3 months before enrollment
* Seizure criteria: simple partial, complex partial, or tonic-clonic seizures
* Subjects with normal cognitive function: patients who can perform normal daily life. If not definite, enrollment will be done with K-MMSE score over 27.

Exclusion Criteria:

* Poor general medical condition: comorbid with heart, lung, liver diseases
* Patients who have history of pseudo-seizure
* Anti-epileptic drugs has been changed in recent one month.
* Chronic alcoholic
* Seizure count cannot be done since seizures occur successively.
* Allergy to fish
* High risk of bleeding such as trauma or operation
* Liver function abnormality
* Pregnant or lactating women, or women who plans to have children
* Patients who have participated in the other clinical trial in recent one month
Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive

The main objective of this study is to know the efficiency (costeffectiveness) at 48 weeks of initiation of antiretroviral treatment. three strategies of treatment.

Secondary objectives:

* patients with virologic response ratio at 48 weeks (less than 50 plasma viral load)
* Change in the number of CD4 cells at 48 weeks
* Change in body composition and mineral density bone (body and lumbar) measurement with DEXA (bone mineral density scan) at 48 weeks
* Change in markers of renal function (creatinine clearance, glomerular filtration rate - eGFR - estimated rate) and renal tubular function at 48 weeks
* Rate of mortality and clinical progression at 48 weeks
* general tolerability and safety: adverse events (AA) and serious AA description

Eligibility Criteria:
Inclusion Criteria:

* 1-negative pregnancy test in women of childbearing age
* 2- stable HIV-1 infection clinically and not take antiretroviral therapy
* 3- viral load HIV \<100,000 copies
* 4- CD4 cells \>100 cels/mm3
* 5- Glomerular filtration \>70mlmin
* 6- have a negative HLA B5701
* 7-.patients should have given informed written consent
* 8- in the opinion of the investigator, be able to follow the design of the Protocol visits

Exclusion Criteria:

* 1-. Patients who had virologic failure with any antiretroviral therapy
* 2- evidence of prior mutations of the study drugs
* 3- use of any anti-retroviral treatment in the 6 months prior to the entry of the study
* 4- contraindication to the drugs study
* 5- any condition that does not allow to ensure the correct compliance to the study
* 6- uncontrolled previous psychiatric illness
* 7- Current or active addiction or alcoholism
Clinical Study of ET190L1 ARTEMIS™ in Relapsed, Refractory B Cell Lymphoma

This study is to determine the safety, including potential dose limiting toxicities, of ET190L1 ARTEMIS™ T cells and the duration of in vivo survival of ET190L1 ARTEMIS™ T cells in patients with relasped/refractory B-cell lymphoma. For patients with detectable disease, the study will also measure anti-tumor responses after ET190L1 ARTEMIS™ cell infusions.

ET190L ARTEMIS™ is a novel chimeric T-cell therapy platform that in preclinical studies, functionally matches the efficacy of CAR T cells, but dramatically reduces the release of cytokines upon killing of target-positive tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed/refractory CD19+ B-cell lymphoma, with no effective therapy available per NCCN guidelines
* No HCV, HIV infection, no active HBV
* Liver and kidney function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) does not exceed five times the upper limit of normal range. ALT \<200U / L, bilirubin \<2.0 mg/ dL
* Renal function: creatinine \<2.5mg / dL; Pre-treatment absolute creatinine clearance ≥50 mL / minute
* CBC: Hemoglobin ≥ 80g / L, Absolute Neutrophil Counts ≥1 × 10\^9 / L, Platelets ≥50 × 10\^9 / L
* Echocardiography or multiple gated angiogram (MUGA) ejection fraction\> 45%
* ECOG performance status ≤2, expected survival time \> 3 months per PIs opinion
* Women of childbearing age should have a negative pregnancy test and agree to use effective contraception during treatment and 1 year after the last dose.
* Had a recurrence after at least a first-line systemic treatment
* Peripheral venous access is available and no issues with apheresis for lymphocyte isolation
* Voluntarily signed informed consent form

Exclusion Criteria:

* Women in pregnancy and lactation
* Unable to perform leukapheresis and iv infusion
* With active infection
* Major organ failure
* Continuously used glucocorticoids or other immunosuppressive agents within 4 weeks
* T cell deficiency or T cells are difficult to be transduced
This Study Compared an in Home Asthma Management Program Provided by Nurses or Respiratory Therapist

This study compared an in-home asthma management program provided by nurses or respiratory therapists to see if those receiving program had fewer hospitalizations, clinic and emergency room visits and higher levels of satisfaction and health related quality of life.

Background: Disease management may improve outcomes and reduce cost. We compared an in-home asthma management program (AMP) delivered by respiratory therapists (RTs) or nurses (RNs) to standard care (SC) in 159 adults with moderate to severe asthma to determine the effect on health care utilization (HCU), patient satisfaction (PS) and health related quality of life (HRQOL).

Methods: This single center, prospective trial randomized subjects, age 18-64, to three groups: SC, AMP-RT or AMP-RN. Outcomes at six-months were HCU, cost, pulmonary function, symptoms, environmental assessment, asthma self-management, HRQOL (SF-36; St. Georges Respiratory Questionnaire \[SGRQ\]) and PS. Frequencies were compared using chi 2; all other variables were compared using ANOVA with a post-hoc test.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age 18-64 years) treated in the ED or hospitalized for an acute exacerbation of asthma at the university teaching hospital were invited to participate.

Exclusion Criteria:

* Included other pulmonary disorders or diagnosis of co-morbid disease which was disabling in nature.
Risk Factors for Cut-out After Internal Fixation of Trochanteric Fractures in Elderly Subjects.

Proximal femoral fracture is associated with severe morbidity and mortality and high socioeconomic costs. The main mechanical complication of internal fixation in trochanteric fracture is lag-screw cut-out through the femoral head. Several factors are involved, but remain controversial. The aim of the present study was to determine risk factors for cut-out in internal fixation of extracapsular proximal femoral fracture.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 75 years of age
* Operated on for extracapsular proximal femoral fracture
* After bodyheight fall

Exclusion Criteria:

* Intra-capsular fractures
* trochantero-diaphyseal fractures
* subtrochanteric fractures
* fractures involving pathological bone
Effect of Education on Resident Physician Knowledge of Sepsis

A questionnaire was provided, including clinical vignettes and free text answers, to assess and evaluate the ability of resident physicians to identify systemic inflammatory response syndrome (SIRS), sepsis, and severe sepsis. Questionnaire scores were compared between specialties. A whole-hospital educational campaign was provided with the aim to improve sepsis recognition, and the questionnaire survey was repeated after one year to assess the effect of the education on the recognition of sepsis.

Sepsis is the number one cause of mortality in US hospitals. An aim of this study was to evaluate the ability of resident physicians with different training backgrounds to recognize SIRS, sepsis, and severe sepsis. A survey assessment of the definition of SIRS, sepsis, and severe sepsis was administered to internal medicine, emergency room, orthopedic, neurosurgery, and general surgery residents. Then, an intensive educational campaign designed to improve recognition of the patient with sepsis was launched. For approximately 1 year, posters with this educational information were displayed in the hospital, one-on-one educational sessions were provided to residents, and didactic sessions focusing on sepsis were conducted. The survey was then redesigned and administered it to the same groups as described previously.

Eligibility Criteria:
Inclusion Criteria:

Resident physician in an University of Utah training program

Exclusion Criteria:

Not willing to participate
Astragalus Membranaceus on Aneurysmal Subarachnoid Hemorrhage

This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients.

Astragalus membranaceus (AM, Huang-Chi) is a Chinese herb used extensively in China as a traditional treatment to treat stroke for a long time, and a number of studies have shown that AM can reduce cerebral infarction area and has anti-oxidation activity. Our previous studies have demonstrated enhanced recovery of neurologic function in patients with acute hemorrhagic stroke who received AM. It is hypothesized that AM either reduces inflammatory response or reduces perihematomal edema.

Subarachnoid hemorrhage secondary to rupture of a cerebral aneurysm is a medical condition associated with a high morbidity and mortality; approximately 10-15% of patients die before reaching medical care, and overall mortality is approximately 45%. Of those that survive, 30% suffer permanent disability graded as moderate to severe, and two-thirds of survivors never return to the same quality of life as they had prior to their hemorrhage. A large number of patients (30-70%) who are able to make it to the hospital and have successful treatment of their aneurysm will develop delayed cerebral vasospasm that is related to the blood clot from their initial aneurysm rupture. Of patients that survive their initial aneurysm rupture, vasospasm results in an additional 7% mortality and another 7% of severe disabilities secondary to ischemic strokes from severe spasm of cerebral arteries.

This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients. All procedures done as a part of this study are standard hospital care procedures done to treat aneurysmal subarachnoid hemorrhage according to the AHA/ASA guideline.

Eligibility Criteria:
Inclusion Criteria:

* Patients who admitted to the hospital within 24 hours of onset of aneurysmal subarachnoid hemorrhage (SAH) stroke
* Subarachnoid hemorrhage documented on head CT
* Hunt Hess Grade 1-4
* Both Male and Female
* Age more than 20 and less than 80 years older
* Informed consent obtained from a patient or legal representative before enrollment

Exclusion Criteria:

* Traumatic or mycotic aneurysms
* Complication of serious heart or hepatic disease or infection or renal failure
* Malignant tumor
* Patients judged to be inappropriate by physician in charge
* Pregnant / breast feeding women
* Patients have enrolled or have not yet completed other investigational drug trials within 1 month before screening
* Ever stroke, and mRS≧3
Determinants of Patients' Uptake of Therapeutic Education Programme

Therapeutic Patient Education (TPE) refers to programs that help patients to manage life with a chronic disease in the best possible way. In spite of the effectiveness of Therapeutic Patient Education, few patients uptake TPE when it is proposed to them. Therefore, our main aim was to identify patients' beliefs that will predict patients' uptake of TPE. According to the Health Belief Model, patient will participate in TPE if they perceive their disease as a serious threat (with possible serious complications), but which can be controlled however, and that TPE is efficient and represents little burden.

Secondary aims are as follows:

1. To test whether the way TPE is presented to patients impact patients' decision to uptake TPE. The way TPE is presented comprises the time between diagnosis and the proposal of TPE, whether patient is a remission or crisis period in the disease, the time between the proposal and the next TPE session, and what is said by healthcare professionals to present TPE.
2. To test whether healthcare professionals' empathy impact patients' decision to participate in TPE
3. To test whether patients' intention to participate in TPE will predict their actual participation.

The ultimate goal of the study is to identify patients whose beliefs will not favor participation in TPE in order to accompany those patients more carefully. Best practices will be proposed according the results.


Eligibility Criteria:
Inclusion Criteria:

* Patients to whom TPE was proposed in diabetes, hemophilia, obesity, cardiac failure, chronic inflammatory bowel disease, parkinson, rare diseases, epilepsy, peripheral arterial diseases
* Belong to a social security scheme
* Pregnant women to whom TPE for gestational diabetes is proposed

Exclusion Criteria:

* Cognitive impairment declared by healthcare professionals
* Inpatients
* Patients for whom TPE is coupled with rehabilitation
* Psychiatric disorders
* Patients who cannot give informed consent
* Patients in jail