cyrilzakka/clinical-trials huggingface dataset:
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease

The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.

The main purpose of this study is to compare two types of care - usual hepatology care and usual hepatology care with early involvement of palliative care clinicians to see which is better for improving the experience of hospitalized patients with advanced liver disease (AdvLD).

The investigators aim to find out whether introducing hospitalized patients with AdvLD to the palliative care team that specializes in symptom management can improve the quality of life and physical and psychological symptoms that patients and families experience during their hospitalizations as well as enhance the quality of patients' end of life care.

Eligibility Criteria:
Patient Inclusion Criteria:

1. Hospitalized patient with a diagnosis of advanced liver disease, defined as cirrhosis with one of the following (new or ongoing) within the prior six months from date of consent:

   * Ascites (requiring diuretics or serial large volume paracenteses)
   * Spontaneous bacterial peritonitis
   * Hepatic hydrothorax (requiring diuretics)
   * Variceal bleed (with one or more occurrences)
   * Overt hepatic encephalopathy (requiring medications)
2. Ability to comprehend English

Patient Exclusion Criteria:

1. Prior history of liver transplantation
2. Have uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder or other comorbid condition which the primary medical, hepatology, and/or transplant surgery teams believes prohibits the ability to provide informed consent
3. Current or recent (within 5 years of receiving curative cancer treatment) history of extrahepatic malignancy (excluding non-melanoma skin cancer)
4. Presence of hepatocellular carcinoma beyond Milan criteria
5. Are already receiving hospice care
6. Receive a score of \<10 on the Simplified Animal Naming Test

Caregiver Inclusion Criteria

1. Adult caregiver (≥ 18 years of age)
2. A relative or friend identified by the patient upon whom the patient relies for help and who likely is to be present in-person during hospitalizations or clinic appointments, or willing to participate by phone
3. Ability to comprehend English and can complete questionnaires

Caregiver Exclusion Criteria

1. Inability to comprehend English
DPNB for Prevention of CRDB

Catheter-related bladder discomfort (CRBD) secondary to an indwelling urinary catheter is defined as an urge to void or discomfort in the supra-pubic region. This symptom complex may cause patient agitated and exacerbated postoperative pain. In clinic, dorsal penile nerve block (DPNB) was applied for penile surgery including circumcision and some anterior urethra surgery. The investigators hypothesize that DPNB relive CRBD for male patients with indwelling urinary catheter under general anesthesia.

CRBD is not uncommon in the postoperative period, especially in male patients who have had urinary catheterization after anesthetic induction under general anesthesia, and this symptom complex may cause patient agitated and exacerbated postoperative pain. According to the previous study, i.v. tramadol 1.5 mg/kg administered 30 min before extubation results in reduction in the incidence and severity of CRBD. In clinical practice, tramadol is associated with side effects including nausea, vomiting, sedation, etc. Clinically, dorsal penile nerve block (DPNB) was applied in penile surgery, and got satisfactory pain relief effect postoperatively without side effects related to tramadol. Besides, we observed patients underwent urethra surgery with urinary catheter left in situ seldom complained of CRBD if DPNB and RB performed at the end of operation. We hypothesized that DPNB could relieve DPNB for male patient with indwelling urinary catheter insertion after induction of general anesthesia.

In this study we compare the efficacy of dorsal penile nerve block (DPNB) with 0.33% ropivacaine and intravenous tramadol 1.5mg/kg in prevention of CRBD, as well as the incidences of side effects postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed
* Male adult patient, aged 18\~50 years old, ASA I\~III
* Surgery under general anesthesia

Exclusion Criteria:

* Bladder dysfunction, such as overactive bladder
* A history of bladder outflow obstruction
* Prostate disease, such as benign prostate hyperplasia, etc.
* Disturbance of central nervous system
Acute Health Effects Due to Ultrafine Particles From Candles and Cooking

People spend up to 90% of their life indoor, and the way we live and behave in our homes has substantial effects on our health and well-being. Particle contamination is suggested to have substantial negative effects on health, with candles and cooking emitting the largest amount of particles, thus being the largest contributors to indoor air pollution.

The overall aim of the present project is to contribute to increased understanding of the association between indoor particulate air pollution and health and well-being.

Introduction: People spend up to 90% of their life indoor, and the way we live and behave in our homes has substantial effects on our health and well-being. Particle contamination is suggested to have substantial negative effects on health, with candles and cooking emitting the largest amount of particles, thus being the largest contributors to indoor air pollution. Little is known about the potential adverse health effects of candles and cooking, and people with asthma may be more susceptible.

Aim: To investigate local and systemic effects of short-term exposure to lit candles and cooking among young asthmatics.

Design: In a randomised double-blinded cross-over study non-smoking asthmatics (18-25 years) were exposed for five hours at three different exposure conditions separated by 14 days; A) clean filtered air, B) lit candles and C) cooking emissions under controlled environmental conditions.

Measurements: TSI P-TRAK Ultrafine Particle Counter was used for particle counts. Health effects, including lung function (FEV1/FVC) and fraction of exhaled nitric oxide (FeNO) were evaluated in relation to local and systemic effects prior to, right after and 24 h. after exposure.

Analysis: Mixed methods approach taking both time and exposure into account.

Eligibility Criteria:
Inclusion Criteria:

* Aged 15-25
* Medically treated / physician diagnosed mild seasonal asthma
* Never smoker or ex-smoker ≥ 6 months
* Allergy \> 1 common allergy

Exclusion Criteria:

* Any other disease that could influence the study parameters
* Conditions that prevent safe access to the climate chambers (such as claustrophobia)
* Perennial asthma
* Need for continuous medical treatment for asthma
* Pregnancy
A Study in Adults With Hereditary Angioedema (HAE) Who Currently Receive Icatibant at Home

The main aim of this study is to describe the treatment patterns, characteristics and outcomes of people with HAE who are currently receiving icatibant in the homecare setting in the United Kingdom (UK).

Participants will be treated with icatibant according to their routine practice via homecare service for icatibant within the UK. Data will be directly collected from participants via study diaries and questionnaires. Participants will be contacted approximately every 90 days during study duration (this can occur via phone or as a face-to-face visit).


Eligibility Criteria:
Inclusion Criteria

* Participants self-administering or receiving care assisted administration of icatibant treatment for patient confirmed diagnosis of HAE Type I or II in the homecare setting
* Participants who are able and willing to complete the study questionnaires
* Participants who are willing to be visited or contacted by a member of the homecare or research team at pre-arranged intervals in order to complete questionnaires

Exclusion Criteria

- Participants who have received icatibant as an investigational medicine as part of a clinical trial
Post-prandial Glucose and Insulin Levels in Type 2 Diabetes Mellitus Patients After Consumption of Ready-to-eat Mixed Meals

The aim of the current study was to compare the effects of three ready-to-eat mixed meals, with a high fiber content and low glycemic index, on postprandial glycemic and insulinemic response in patients with Type 2 diabetes mellitus (T2DM).

The current study followed a prospective, three-way, cross-over design. Twenty four patients with T2DM consumed three ready-to-eat mixed meals, i.e. "wild greens pie" (meal 1), "chicken burgers with boiled vegetables" (meal 2) and "vegetable moussaka" (meal 3) and an oral glucose load, all providing 50g of carbohydrates. Venous blood was collected at 0, 30, 60, 90 and 120 minutes postprandial for serum glucose and insulin measurements.

The test meals were consumed by study participants between 8:30 to 9:00 am and within 10-15 minutes under a researcher's supervision, following collection of the fasting blood sample. No parallel fluid intake was allowed. The portion size in the case of each one of the three test meals was adjusted to contain 50g of carbohydrates. However, the three test meals were considerably differentiating among them with respect to their content in calories and the remaining macronutrients.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are eligible if they are 45-75 years of age
* non-insulin-dependent T2DM with an elapsed time since diagnosis of more than 3 years
* Body Mass Index (BMI) value higher than 20 kg/m2
* HbA1c levels of 6.5 to 11%

Exclusion Criteria:

* insulin-dependent T2DM
* cardiovascular (i.e. coronary heart disease, stroke etc.)
* liver and/or renal disease
Hypothalamo-, Pituitary-, Adrenal Axis Dysfunction in Subarachnoid Hemorrhage

Subarachnoid haemorrhage (SAH) may cause damage to the hypotalamo-pituitary-adrenal axis (HPA) thus disturbing the hormonal response of these structures.

The aim of our study is to characterize the function of HPA-axis acutely and over time up to three months in patients with SAH.

The hypotalamo-pituitary-adrenal (HPA)-axis may be affected in SAH by temporary or permanent damage to the hypothalamus and/or pituitary gland. Also surgery or endovascular treatment of a ruptured intracranial aneurysm may affect the hormonal response of the HPA-axis. Some data suggest a high incidence of delayed endocrine abnormalities in patients with SAH but only little data exists on the acute endocrine abnormalities in this disease.

We will study the pituitary-adrenal hormone levels in patients with acute aneurysmal SAH and patients admitted for elective cranial aneurysm surgery will serve as a control population. We will use serum free cortisol calculation and total cortisol measurements as well as adrenocorticotrophic hormone (ACTH) stimulation test in assessing the responsiveness of the adrenal gland to exogenous ACTH. The hormone levels will be measured repeatedly during the first seven days after SAH and once at three months.

Eligibility Criteria:
Inclusion Criteria:

SAH-group:

* \>age 18,
* Subarachnoid hemorrhage due to an cerebral aneurysm

Control group:

* Age \>18
* Admitted for elective primary cerebral aneurysm surgery

Exclusion Criteria:

SAH group:

* Any corticoid treatment (also inhaled)
* Usage of etomidate before study entry or during the study period
* Exact bleeding day unknown
* Previous history of SAH or more than three days of current bleeding
* Previous aneurysm surgery or embolization
* Traumatic SAH
* Known pituitary insufficiency and moribund state of the patient
* Refusement of the patient

control group:

* Any corticoid treatment (also inhaled)
* Usage of etomidate before study entry or during the study period
* Previous history of SAH or cerebral aneurym surgery or embolization
* Admitted for elective aneurysm embolization
* Known pituitary insufficiency
* Refusement of the patienT
Predictive Models of Treatment Responses and Survival Outcomes in Patients With Soft Tissue Sarcoma

The aim of this study was to developed and validated models to predict therapeutic responses and patients' survivals in patients with soft tissue sarcoma and compared these models with currently available models.

We performed a retrospective-prospective cohort study with the aim of developing and validating comprehensive models to predict treatment responses and survival outcomes in patients with biopsy-proven soft tissue sarcoma. Secondly, we aimed to compare the predictive accuracy with currently available noninvasive model.

Eligibility Criteria:
Inclusion Criteria:

* Receiving no treatment before diagnosis
* With written informed consent

Exclusion Criteria:

* Clinical data missing
* Without written informed consent
Phase IIaTrials of GanMaoKangNing Granules

Randomized, double-blind, double- simulation, positive drug-and-Placebo-Controlled, multicenter, phase IIa clinical trials Study about GanMaoKangNing Granules in improving the symptoms of influenza.


Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent;
* Male and female patients aged between 18 and 65 years old , there is no limit on the gender;
* In line with the diagnostic criteria for pandemic influenza;
* Duration less than 48 (Duration is defined as the time from onset to test drugs for the first time before, the onset time pointed out that now the axillary temperature 38.0 ℃, headache, muscle or joint pain, chills, fatigue, cough, sore throat and a stuffy nose eight any flu symptoms and signs in time);
* The axillary temperature is 38.0 ℃ or higher;
* Nose and throat swabs rapid virus antigen test result is positive.

Exclusion Criteria:

* Severe influenza and of patients with complications of influenza.
* With the following any severe risk factors:

A. With chronic respiratory diseases such as bronchial asthma, chronic obstructive pulmonary disease (copd), etc.

B. with chronic diseases of the cardiovascular system, such as congestive heart failure, high blood pressure.

C. with chronic metabolic and endocrine system diseases, such as poorly controlled diabetes (HbA1c 7.0% or higher).

D. with chronic kidney disease, chronic liver disease, blood system diseases, neurological and neuromuscular diseases (such as epilepsy, cognitive impairment, etc.).

E. A weakened immune system, such as long-term use of immunosuppressive agents, HIV infection or tumor.

F. Under the age of 19, long-term aspirin use. G. The obese (BMI BMI \> 30).

* With influenza complications, such as secondary bacterial pneumonia and other pathogenic bacteria and other viral pneumonia caused by pneumonia.
* A history of peptic ulcer disease or gastrointestinal bleeding.
* Into the group received within 48 h before flu antiviral treatment.
* Into the group of 12 months before been vaccinated against the flu.
* Into the group used within 2 weeks before the monoamine oxidase inhibitors.
* Blood leukocyte count \> 10.0 x 109 / L, neutrophils ratio \> 80%, or the need for systemic antibiotic therapy.
* For GanMaoKangNing Granules, Oseltamivir Phosphate Capsules, Acetaminophen Tablets, Dextromethorphan Hydrobromide Capsule, GanMaoKangNing Granules simulation agent or Oseltamivir Phosphate Capsules simulation agent composition of allergy, or allergic constitution.
* Aminotransferase (AST/SGOT) or alanine aminotransferase (ALT/SGPT) ≥ 1.5 x Upper Limit Normal (ULN)， Scr \> Upper Limit Normal (ULN).
* Doubt or does have a history of alcohol or drug abuse.
* Pregnancy (defined as the pregnancy test positive), nursing mothers, or past in family planning.
* For nearly three months participated in other clinical trials of patients.
* Researchers think not appropriate to participate in this clinical subjects.
The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.

The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac surgery patients. Systemic inflammatory response initiated by CPB through releasing of several mediators lead to altered endothelial integrity and in consequence the leakage of proteins and fluids from the intravascular to the interstitial compartment is occurred. Increased capillary permeability and decreased colloid osmotic pressure were shown to play a key role for fluid shift and increasing of extravascular water. Further tissue edema can result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to adverse outcomes.

Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid shift from the intracellular and the interstitial spaces of tissue into the intravascular compartment.

The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass

Exclusion Criteria:

* age \>70 years
* body mass index \<18 and \>35 kg/m2
* left ventricular ejection fraction \<40%
* myocardial infarction \<6 months before surgery
* stroke or transient ischemic attack \<12 months before surgery
* diabetes mellitus
* glomerular filtration rate \<90 mL/min
* emergency surgery
* hematocrit \<30%.
Self-management Compared to Care-as-usual for Men With Lower Urinary Tract Symptoms

Research question: Does offering an online self-management program lead to more efficient use of care by men with urinary complaints? Hypothesis: Many men with urinary symptoms receive medication from their GP. Advice on how to self-manage complaints is often skipped. This while self-management is effective. By offering self-management instead of visiting a GP the use of care by men with urinary complaints may decrease and treatment may become more efficient.

Study design: Men are randomized to receive either care-as-usual by their GP or the online self-management program. Men will be followed for six months and the cost-effectiveness of the online self-management intervention will be compared to the care-as-usual

Rationale: Although self-management can be difficult to implement because it is time consuming to explain, it has proven effective for LUTS. For this reason, we developed an online intervention that can be used at home by men with LUTS, giving tailored advice to each case. Objective: To assess the effectiveness and cost-effectiveness of providing an online personalized self-management program as a first-line intervention to men with lower urinary tract symptoms (LUTS) compared to care as usual (CAU).

Study design: A pragmatic non-inferiority randomized controlled trial in the general population. Study population: Men with LUTS (\>18 years of age) who are considering visiting a general practitioner for their complaints.

Intervention: Access to an online program offering personalized selfmanagement advice compared to care as usual Main endpoints: Outcomes will be assessed at 6 weeks, 3 months and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Men with lower urinary tract symptoms who are thinking about visiting a GP for their complaints

Exclusion Criteria:

* Men with complicated LUTS who should seek urgent care, including those with nocturnal incontinence (e.g., chronic urinary retention), the inability to void despite urgency (e.g., acute urinary retention), and with sudden onset or worsening LUTS (e.g., urinary tract infections).
* Men receiving treatment from a pelvic physiotherapist, GP, or urologist (including at any point in the previous year).
* Men with a history of prostate cancer, bladder cancer, or urinary tract surgery
A Study to Learn About the Study Medicine Called Rimegepant in Women When Used for Intermittent Prevention of Menstrual Migraine

The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.


Eligibility Criteria:
Inclusion Criteria:

1. Participant has regular menstrual cycles ≥24 days and ≤34 days
2. A minimum 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition
3. A history of menstrual migraine attacks of at least 3 months
4. Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening.
5. If the participant is receiving a permitted background continuous prophylactic migraine medication, the medication dose must be stable for at least 3 months prior to the Screening visit and, the dose is not expected to change during the course of the study

Exclusion Criteria:

1. Greater than 6 migraine days per month that are outside of the perimenstrual period in the 3 months prior to Screening
2. A diagnosis of chronic migraine or a history of more than 14 headache days per month on average, in the 3 months prior to Screening
3. History of retinal migraine, basilar migraine or hemiplegic migraine
4. Current diagnosis of schizophrenia, bipolar, or borderline personality disorder
5. Other pain syndromes (eg, fibromyalgia, complex regional pain syndrome), or significant neurological disorders (other than migraine), or other medical conditions (including endocrine and gynecological eg, severe dysmenorrhea
Serum NGAL Levels in Hemodialysis (HD) Patients; Relation to Iron Status, HD and Intravenous (IV) Iron Administration

The purpose of this study is to assess changes in serum levels of the siderophore binding protein NGAL by hemodialysis without and with intravenous iron administration

Serum and urine levels of the siderophore binding protein neutrophil gelatinase associated lipocalin (NGAL) are increased in a number of renal diseases, but has not been evaluated yet in dialysis patients. Since NGAL is suggested to be related to inflammatory processes and iron homeostasis, which are a major problem in dialysis patients, this study aims to assess the relation of serum NGAL levels in hemodialysis (HD) patients to iron status, inflammation, hemodialysis and intravenous(IV) iron administration. Our hypothesis is that serum NGAL levels in HD patients are related to iron status and inflammation and may change following hemodialysis and/or acute or chronic IV iron administration.

The Specific aims are:

1. To assess the relations between basal serum NGAL levels to iron, dialysis, and inflammation related parameters.
2. To assess the effect of HD on serum NGAL levels and their relation with with iron, dialysis and inflammation related parameters.
3. To assess the effects of weekly 100 mg IV iron in the first hour of HD on serum NGAL levels, and the relation of pre IV iron serum NGAL levels with iron, oxidative stress and inflammation related parameters. These assessments will be performed in the first weekly HD.

Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients

Exclusion Criteria:

* Acute disease (infection, thrombosis, ischemia, bleeding)
* Hepatitis B, Hepatitis C or HIV
* Intravenous iron administration or packed red cell transfusion in the last 4 weeks prior to the study