cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Care Burden of Caregivers of Patients With Brain Injury and Determining the Influencing Factors

Acquired brain injury is a general term including trauma due to head injury or postsurgical damage, vascular accident such as stroke or subarachnoid hemorrhage, toxic or metabolic cause such as hypoglycemia, cerebral anoxia, and infection or inflammation. However acquired brain injury leaves survivors with a considerable burden of physical, cognitive, emotional,behavioural and psychosocial limitations,these individuals often require healthcare, supervision, and support from professional or informal caregivers in some or all of their lives. Therefore, this study have two primary aims: (1) to conclude the level of caregiver's life satisfaction and strain; and (2) to determine the factors predicting strain among the caregivers. İnvestigators believe this study can add to the literature and create awareness on the current state of caregiver's well-being in this part of the world.

Patients will evaluate with respect to their demographic and clinical determinants. In the patient group, ambulation status, disability levels, cognitive status, neurobehavioral results, functional status will evaluate with the Functional Ambulation Classification Scale (FACS), Disability Rating Scale (DRS), Rancho Los Amigos Cognitive Scale-Revised (RLAS-R), Neurobehavioral Rating Scale-Revised (NBRS-R), Functional Independence Measure (FIM) respectively. All assessments will conduct and evaluate by the treating physicians during hospitalization.

İnvestigators also will record the type of caregiving (family member or paid professional) and socio-demographic characteristics of the caregivers . Sleep quality will be determined with Pittsburgh Sleep Quality İndex (PSQI), quality of life with NHP (Nottingham Health Profile), level and risk of anxiety and depression with Hospital Anxiety and Depression Scale, satisfaction level with The Satisfaction with Life Scale , care burden with Caregiver Strain Index (CSI).

Eligibility Criteria:
Inclusion criteria for the patients:

* have a nonprogressive, non-neurodegenerative acquired brain injury
* able to read or understand the questionnaire
* at least 18 years of age

Inclusion criteria for the caregivers:

* primary caregiver of a patient diagnosed with acquired brain injury
* at least 18 years of age
* had provided care for at least one month
* providing care to the patient for more than 4 h per day
* did not have any major premorbid medical and psychological illnesses
* able to read or understand the questionnaire

Exclusion criteria for patients and caregivers:

* under 18 years of age
* inability to read and understand questions.
A Retrospective Cohort Study of Differential Attainment, COVID-19 and Chaos

A retrospective cohort study of Differential Attainment, COVID and Chaos: taking the difference out of a terrible trinity

Background: This study aimed to evaluate Core Surgical Training (CST) Differential Attainment (DA) related to COVID-19 and gender in three ethnic cohorts: White UK (WUKG), Black \& Minority Ethnic UK (BMEUKG), and International Medical Graduates (IMG). The hypothesis was that COVID-19 adversely influenced CST outcome.

Methods: Anonymised 234 CST and 37 IST records (152 WUKG, 81 BMEUKG, 38 IMG) in a UK Statutory Education Body (SEB) were examined. Primary effect measures were: Annual Review of Competency Progression Outcome (ARCPO), MRCS pass, and National Training Number (NTN) appointment.

Eligibility Criteria:
Inclusion Criteria:

* CST

Exclusion Criteria:

* Not completed training
Celecoxib Versus Diclofenac In The Treatment Of Osteoarthritis Of The Hip

To determine if celecoxib 200 mg once daily is as effective as diclofenac 50 mg three times daily in the treatment of pain symptoms associated with osteoarthritis of the hip


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with osteoarthritis of hip and requiring joint replacement
* Eligible for chronic therapy with an NSAID

Exclusion Criteria:

* Hip surgery anticipated within 8 calendar weeks after first visit
* Active gastrointestinal disease or recent diagnosis of gastrointestinal ulceration (within 60 days of first visit)
Doppler-based Renal Resistive Index in Assessing Renal Dysfunction Reversibility in ICU Patients

Acute kidney injury (AKI) is common in intensive care unit (ICU) patients and remains associated with a dismal prognosis. The diagnosis of AKI relies on functional criteria (oliguria and serum creatinine elevation), which carry several important limitations. Additionally, the investigators lack biomarker that may predict short term renal prognosis.

Doppler-based renal resistive index (RI) measurement is a rapid and noninvasive investigative tool that may hold promise for early AKI detection in ICU patients or in differentiating transient from persistent AKI in selected critically ill patients. Although several studies have suggested adequate performance in predicting short-term reversibility of AKI, most of these studies were performed in limited patient samples. Additionally, a recent study has identified discrepant results regarding its diagnostic performance.

The main objective of this large prospective multicentre study is to assess diagnostic performance of Doppler-based renal resistive index in diagnosing persistent AKI in critically ill patients requiring mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Sinus rhythm
* Use of conventional mechanical ventilation

Exclusion Criteria:

* Refusal: patient, family or trusted person to participate in the study
* Renal artery stenosis known
* Pregnant
* Severe Chronic Renal Failure (clearance \< 30 ml.min-1)
Safety Study of Adult Mesenchymal Stem Cells (MSC) to Treat Acute Myocardial Infarction

The purpose of the study is to determine whether adult stem cells \[Provacel™(PUMP1)\] are safe and possibly effective in the treatment of acute myocardial infarction (heart attack).

Cardiovascular disease is the single largest killer of males and females in the United States with an average of 335,000 deaths per year. This year an estimated 700,000 Americans will suffer an acute myocardial infarction. The standard of care treatment for acute myocardial infarction (MI) usually includes immediate perfusion, optimal pain relief, oxygen, aspirin or other anti-coagulants, Beta-Blockers, nitrates and Ace-inhibitors. Management of cardiac risk factors such as tobacco use, hypertension, lipid levels, diabetes, weight control and exercise all work to reduce further atherosclerotic events. Yet, many patients go on to develop Congestive Heart Failure (CHF). Medical management for CHF may improve symptoms and slow the progression to failure but does not restore a functioning myocardium. A therapy that could improve the myocardial remodeling process and reduce the incidence or severity of CHF following acute MI would provide a significant benefit in an area of unmet medical need.

Patients will receive standard of care in addition to stem cells or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 21 and 85 years old
* First heart attack within 1 to 10 days

Exclusion Criteria:

* Positive for HIV 1 and 2
* Previous heart attack
* Pacemaker or other device
* Pregnant or breastfeeding
* Allergic to cow or pig derived products
* Previous bone marrow transplant
* Involved in another clinical trial within the past 30 days
* Alcohol or recreational drug abuse within the past 6 months
* Hepatitis Positive
* Major surgical procedure or major trauma within the past 14 days
* Body weight greater than 300 pounds
* Autoimmune disease ( e.g. Lupus, Multiple Sclerosis)
A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers

The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics and safety of Remimazolam Tosylate with midazolam in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females
* Weight range 50 to 100 kg inclusive
* Body mass index (BMI) 18 to 26 kg/m2

Exclusion Criteria:

* Has a known sensitivity to benzodiazepines, flumazenil, or anesthetic agents, or a medical condition such that these agents are contraindicated
* With evidence of uncontrolled renal, hepatic, central nervous system, respiratory, cardiovascular, or metabolic dysfunction, in the opinion of the investigator or medical monitor
* Has known or suspected history of alcoholism or drug abuse or misuse within 6 months of Screening or evidence of tolerance or physical dependence before dosing with study drug
* With a history of laboratory results that show the presence of hepatitis B surface antigen (HBs Ag), hepatitis C antibody (HCV Ab), or human immunodeficiency virus (HIV)
* Pregnant,lactating
* Mallampati score ≥3
Profiling of Post Covid-19 Infection Patients: an Online Survey

The aim of this study is to explore the relation between indicators of central sensitisation, quality of life and functional status in patients post covid-19 infection.


Eligibility Criteria:
Inclusion Criteria:

* male and female adults who were previously infected with covid-19
Dual-task Gait Performance in People With Knee Osteoarthritis Before and After Knee Replacement Surgery

Knee Osteoarthritis (OA) is one of the most common conditions causing disability and limitation in the elderly population, with 13% of women and 10% of men over the age of 60 suffering from symptomatic knee osteoarthritis. Pain and other symptoms of OA significantly affect the quality of life, manifesting itself in pain, decreased range of motion, functional limitation and change in gait patterns.

Total Knee Replacement Surgery (TKR) is the most common solution for patients with advanced cartilage erosion and is considered a successful surgery with high satisfaction rates (about 80%). The surgery becomes necessary when pain limits the daily functioning and impairs the quality of life and after the failure of conservative treatment.

Still, patients undergoing TKR suffer in the first period after surgery from pain, decreased balance and proprioceptive impairment. Despite the improvement in pain and function, the rates of falls after surgery do not change drastically and remain high.

About a third of older adults fall each year, leading to fractures, functional decline and in some cases death. Walking is a complex task, and with advancing age walking becomes less automatic and requires additional attention. Among adults, it is known that an increased risk of falls is associated with reduced ability to perform complex walking tasks, such as walking while talking or crossing obstacles.

After TKR, most falls occur while walking due to slipping / tripping. In addition, proprioceptive impairment, pain and poor balance are associated with an increased risk of falling after TKR. The mechanism underlying these effects may be increased allocation of cognitive resources to walking. Thus, this study will examine the ability of people before and after TKR to perform complex walking tasks, in order to examine the change in attention allocation to walking following surgery. It is hypothesized that after surgery, the ability to walk while performing an additional task will be lower than prior to surgery.


Eligibility Criteria:
Inclusion Criteria:

* Able to walk at least for 1 minute with no assistive device
* Able to understand and complete simple instructions

Exclusion Criteria:

* Diagnosed dementia
* Diseases impairing balance
* Diagnosed rheumatoid arthritis
Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

The purpose of the study is to evaluate whether the addition of Diamel, a nutritional supplement, to hypocaloric diet and exercise could improve the histological results (steatosis, necro-inflammatory activity and fibrosis), insulin resistance, aminotransferase levels and anthropometric measures in comparison with a placebo-controlled group with hypocaloric diet and exercise during 52 weeks of treatment in patients with nonalcoholic steatohepatitis.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of steatohepatitis (minimal histological criteria for steatohepatitis include steatosis involving at least 5% of hepatocytes, lobular inflammation, and/or fibrosis)
* Age between 18 and 70 years
* Ability to provide informed consent
* Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)

Exclusion Criteria:

* Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, metabolic and hereditary liver disease and α-1 antitrypsin deficiency)
* Pregnancy or lactation
* Decompensated cirrhosis
* Presence of secondary cause of NAFL such as medications that induce steatosis (corticosteroids, estrogens, methotrexate, amiodarone, tamoxifen and calcium channel blockers) and gastrointestinal bypass surgery
* Pharmacological treatment with some potential benefit on NAFL including ursodeoxycholic acid, vitamin E, betaine, pioglitazone, rosiglitazone, metformin, pentoxifylline or gemfibrozil
* Fasting glucose levels greater than 250 mg per deciliter (13.3 mmolm per liter)
* Contraindication to liver biopsy
* Refusal to participate in the study
* Concomitant disease with reduced life expectancy
* Severe psychiatric conditions
* Drug dependence
Intranasal Insulin for COVID-19-related Smell Loss

The aim of this study was to quantify the improvement in olfaction of 27 post-COVID-19 patients, after three intreventions of intranasal insulin during a four week period, with the help of the Threshold, Discrimination and Identification (TDI) score evaluated with Sniffin Sticks®.


Eligibility Criteria:
Inclusion Criteria:

* COVID-19 in the last 3 to 18 months and who persisted with anosmia, hyposmia or other olfactory dysfunction chronically and without improvement

Exclusion Criteria:

* nasal tumors, chronic sinusitis, drug-induced sinusitis, nasal polyposis, neurodegenerative disease, smoking, pregnancy Hypoglycemia and a previous diagnosis of diabetes mellitus or anatomical malformations such as septal deviation, rhinosinusitis or choanal atresia
Effects of Hippotherapy on Physical Fitness and Attention in Cerebral Palsy

This research analyzes whether hippotherapy improves the physical activity, cardiopulmonary fitness, and attention in children with cerebral palsy and whether this enhances their general health and quality of life.

This research aims to promote hippotherapy by scientifically proving its therapeutic effects and mechanism to contribute to improving the health and quality of life of the patients as well as reducing their global burden of disease by shifting the current passive "therapy-oriented" paradigm to a more proactive "participation-oriented" paradigm.

Ever since physical activity and physical fitness have been reported to have an inverse relationship with the mortality rate, especially deaths due to cardiovascular disease, various efforts have been made to optimize physical activity and physical fitness among children with cerebral palsy. ADHD is one of the most common coexisting conditions of cerebral palsy. More participation in engaging sports activities like therapeutic riding is anticipated to improve patient health and their quality of life.

Hippotherapy is expected to improve clinical symptom of ADHD in children with cerebral palsy while preventing possible ensuing psychiatric disorders, thereby bringing significant improvement in their health and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of spastic CP
* GMFCS level I-III
* weight \< 35kg
* ability to walk independently with or without an assistive device
* ability to comply with the study protocol and follow verbal directions

Exclusion Criteria:

* botulinum toxin injection within 3 months
* orthopedic surgery within 1 year (difficulty performing one step instructions)
* moderate to severe intellectual disability
* uncontrolled seizure
* poor visual or hearing acuity
* patients who weigh more than 35 kg
* hip dislocation
* scoliosis more than 30 degrees
* musculoskeletal surgery within 1 year
Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)

This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib in patients with myelofibrosis (MF). The study consists of two periods: the core study period, comprising the dose escalation stage and the safety extension phase up to Week 24, then the extension study period beyond Week 24 and up to 3 years, to further characterize the safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting platelet counts \< 100 x 10 \^9/L


Eligibility Criteria:
Inclusion Criteria:

* Require treatment for MF and classified at least as intermediate risk level 1 defined by the International Working Group.
* Platelet count \< 100x10 \^9/L at screening or at Study Day 1.

Exclusion Criteria:

* Received platelet transfusion within 14 days prior to Screening evaluations.
A Trial of GS-9219 in Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM)

Multi-center, open-label, single-dose, dose-escalating Phase I/II study of GS 9219 in adult patients with relapsed or refractory CLL, NHL or MM. Patients will be enrolled into the study in sequential dose cohorts.

Patients will be administered a single IV infusion of GS 9219 on Day 1 of a 21 day cycle and may receive a total of six treatment cycles based on toxicities and response. Patients who demonstrate disease progression will be discontinued from the study. Patients who, at the completion of six treatment cycles, tolerate treatment and show evidence of disease control (response or stabilization) will be eligible to continue receiving treatment at the same dose.

The primary objective of this study is as follows:

To assess the safety, toxicity, and maximum tolerated dose (MTD) of GS 9219 administered via IV administration once every three weeks (21 days) for six treatment cycles, i.e. for a total of 18 weeks, in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Non-Hodgkin's Lymphoma (NHL) or Multiple Myeloma (MM).

The secondary objectives of this study are as follows:

To determine the pharmacokinetic parameters of GS 9219 for this regimen and patient population.

To assess the antitumor activity of GS 9219 based on Response Rate and Duration of Response. Progression-free Survival and Overall Survival will be assessed if applicable.

Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory CLL, NHL or MM
* ECOG Performance Status of 0, 1, or 2
* Adequate organ function (protocol defined)
* ECG without evidence of clinically significant ventricular arrhythmias

Exclusion Criteria:

* AIDS-related lymphoma
* Subjects with NHL who present exclusively with non-measurable lesions
* Subjects with MM who have non-secretory and/or non-measurable disease
* Recent anticancer therapy (chemotherapy, radiotherapy, and/or biotherapy)within four weeks prior to starting treatment
* Evidence of pulmonary fibrosis
* Other concurrent malignancy
* Uncontrolled concurrent illness
* Receiving chronic, systemically administered steroids
* Known hypersensitivity to nucleoside analogues
VE303 for Treatment of Hepatic Encephalopathy (HE)

This research is studying the use of a new drug to learn about its safety and efficacy as a treatment for hepatic encephalopathy.

Eligible participants will be enrolled and given oral antibiotics followed by 14 days of the study drug (placebo vs.VE303). There will be visits as well as other procedures to collect blood and stool samples, and have tests of your cognition (thinking) for this research study.

The hypothesis is that VE303 will safely and effectively improve cognitive function in patients with a history of overt hepatic encephalopathy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cirrhosis based on liver biopsy, imaging, or evidence of clinical decompensation
* History of at least one episode of overt HE any time in the past
* Prescribed both lactulose and rifaximin, and compliant with this treatment

Exclusion Criteria:

* Current episode of overt HE
* Variceal bleeding in the last 4 weeks
* Gut-absorbable or intravenous antibiotic therapy in the last 28 days
* Fecal microbiota transplant in the last 6 months
* Use of probiotics in the last 2 weeks
* Alcohol or illicit drug intake in the last 4 weeks
* Primary sclerosing cholangitis as etiology of liver disease
* History of inflammatory bowel disease, short gut, gastrointestinal tract fistulas, intestinal ischemia, or any form of ongoing colitis
* Prior diagnosis of dementia or other primary neurocognitive disorder
* Known hypersensitivity/allergy/intolerance to Vancomycin and any ingredients of VE303: sucrose, histidine, yeast extract, cysteine, metabisulfite, and microcrystalline cellulose
* History of Roux-en-Y Gastric bypass
* Any gastrointestinal surgery in the last year
* Substantial immune compromise/deficiency (e.g., uncontrolled human immunodeficiency virus, active immune suppressive therapy including high doses of corticosteroids or medications to prevent graft rejection, recent myeloablative therapy, sustained neutropenia)
* Pregnancy or breast feeding
* Model for end-stage liver disease (MELD) \> 20
* History of spontaneous bacterial peritonitis
* Hemodialysis in the last 28 days
* Placement of a portosystemic shunt or transjugular intrahepatic portosystemic shunt in the last 3 months (permissible if placed \>3 months before enrollment)
* Unstable doses of opiates, benzodiazepines or other sedating medication
* Chronic methadone or low dose benzodiazepines (for example) is acceptable
Nutritional Intervention to Reduce Alcohol Consumption

To test whether the implementation of a modified ketogenic diet (KD) is efficient in reducing outcome measures in relation to alcohol consumption in patients with alcohol use disorder (AUD).

This pilot study aims at testing randomization and feasibility of implementing a modified KD in patients with AUD undergoing standard alcohol withdrawal treatment. For this purpose, a a standardized nutritional intervention consisting of interprofessional consultations by clinical dieticians and medical professionals will be implemented. Patients in the control group will be randomized in an AUD as usual treatment with an additional optional nutritional consultation. After dismission of inpatient care, the participants will be followed up for adherence to the modified KD in the outpatient clinic for 5 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* AUD diagnosis according to Diagnostic and Statistical Manual (DSM)-5
* BMI \> 22 (because of potential modified KD-side effect of weight loss)
* Able to give informed consent as documented by signature
* Last alcohol drink intake within 72 hours before treatment initiation

Exclusion Criteria:

* Pregnant or lactating women,
* Inability or contraindications to undergo the investigated intervention (BMI\<18)
* Clinically significant concomitant diseases impairing reasonable decision making (e.g. psychosis, dementia)
* Inability to follow the procedures of the study, e.g. due to language problems, Previous enrolment in a clinical trial
* Patients undergoing opioid maintenance treatment
* Patients taking medications for drinking relapse prevention
* Patients with a blood hemoglobin A1C (HbA1C) \> 7%