cyrilzakka/clinical-trials huggingface dataset:
The Effect of ABPM on Sleep Disturbance

Ambulatory blood pressure monitoring (ABPM) is an ideal tool for the diagnosis and evaluation of hypertension.However, ABPM frequently measures the tightening feeling and buzzing sound of the blood pressure cuff during nighttime, which can cause the patient to wake up easily during sleep, which will affect the sleep of the patient. Moreover, improper awakening of the patient from sleep can significantly increase the patient's blood pressure and affect the accuracy of ABPM monitoring. The Effect of ABPM on Sleep Disturbance (EMBED) study is designed to examine whether ABPM affects sleep, as well as the relationship and influencing factors of sleep and ABPM results, and screening for people who are susceptible to ABPM testing.

Participants who accept ABPM in the Second Affiliated Hospital of Zhejiang University School of Medicine, will be recruited for EMBED enrollment. Participants will be asked to provide basic background information and to fill out the STOP-BANG evaluation form. Anxiety, depression, insomnia, sleep questionnaire and pain assessment scale for cuff inflation are used to assess characteristics of participants and their sleep quality. Before ABPM starts, office blood pressure of participants will be measured. Participants will undergo ABPM under standardized guidance. At the end of ABPM, participants will be asked to fill in sleep questionnaire and pain assessment scale for cuff inflation again. EMBED proposes to study whether ABPM affects sleep, as well as the relationship and influencing factors of sleep and ABPM results, and screening for people who are susceptible to ABPM testing. A better understanding of interaction between ABPM and sleep will help us further evaluate the accuracy of ABPM and more precisely control diurnal hypertension in the future.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent
2. Age 18-80 years
3. Capable of understanding the test and cooperating with the questionnaire.

Exclusion Criteria:

1. History of psychosis, including schizophrenia, bipolar disorder, depression, anxiety, obsessive-compulsive disorder, phobia, somatoform disorder, stress-related disorders
2. History of insomnia, currently with medication
3. History of obstructive sleep apnea (OSA)
4. History of other sleep disorders, including narcolepsy/hypersomnias, circadian rhythm sleep disorder, parasomnias, sleep-related dyskinesia
5. History of heart failure, that is New York heart association (NYHA) Class Ⅲ-Ⅳ
6. History of atrial fibrillation and frequent atrial or ventricular extrasystoles
7. Ongoing substance or alcohol abuse
8. Currently receiving sedative hypnotic medication within 1 week
9. Pregnant women
10. Ongoing involvement in night-shift work (22:00-6:00) within 1 week
11. Ongoing need of care of families at home that wake during the night within 1 week
12. Incomprehensible or unwilling to fill in informed consent or questionnaire
Home-based E-biking Intervention Among Individuals With Cerebral Palsy

Investigation of the feasibility of virtually group-based e-biking training at home. Individuals aged 13-60 years with CP (Cerebral Palsy) with a Gross Motor Function Classification System score of 1-3 were recruited for a 12-week home-based e-biking training program.

All participants should be able to use a touchscreen, as this type of technology is used in the virtual e-biking training. Participants complete a questionnaire and subsequently engage in 12 weeks of home-based virtual e-biking training. A loaned bicycle will be provided for the training period and set up in the participants' own homes. Setup and adjustments will be performed by trained healthcare personnel. The following measurements will be taken before and after the training period: weight, height, hip-waist measurements, blood pressure, a 30-second sit-to-stand test, a timed-up-and-go test, ankle measurements, and a functional threshold power test (FTP). Seven accelerometers will be attached to the right and left arms, thighs, lower legs, and sternum using NJaP patches and worn for 72 hours at the beginning and end of the training period. The accelerometers can be easily removed after 72 hours.

The e-biking intervention consists of 3 sessions per week at the beginning of the study and gradually increases over the training period to 6 sessions per week, with three of these sessions being online and group-supervised.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with cerebral palsy (GMFCS 1-3)
* Are able to keep balance on a stationary bike
* Are able to use a touchscreen

Exclusion Criteria:

-
Chemotherapy Related Anemia in Patients With Non-Myeloid Malignancies

Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving chemotherapy every three weeks. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.


Eligibility Criteria:
* Patients with non-myeloid malignancies \* Patients receiving at least 12 weeks of chemotherapy on a 3-week cycle schedule \* Patients with anemia (hgb \>/= 9.0 and \</= 11.0 g/dL)
Multicenter RCT of ADV-TK Gene Therapy Improving the Outcome of Liver Transplantation for Advanced HCC

Compare the effect of liver transplantation (LT) plus ADV-TK gene therapy versus LT only in advanced primary hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years of age (Male and Female).
* Clinical diagnosis of advanced primary hepatocellular carcinoma who could accept liver transplantation.
* Patients who had unresectable HCC with single tumor diameter \> 5 cm and ≤ 10cm; or numbers of multiple tumors \>3 and ≤ 5, and the total length of foci diameter ≤ 15 cm.
* Serum AFP ≤ 10000 ng/ml before liver transplantation.
* Child-pugh A-B.
* No metastasis in extrahepatic main vescular and extrahepatic lymph node detected during the operation and no metastasis of other organs.
* Provide written informed consent before screening.

Exclusion Criteria:

* Metastasis in extrahepatic organs.
* HCC with Invasion in extrahepatic main vescular and extrahepatic organs.
* Contraindications of operation of other organ system.
* Hypersensitivity to adenovirus, GCV or similar drugs.
* Serious obstacle of the mechanism of coagulation, hemorrhagic tendency, and abnormal coagulation (≥50%).
* Plan to accept clinical trials of other antitumor drugs.
* Immunological deficit.
* HBsAg(+) and HBcAb(+) donor.
* Unsuitable participate assessed by investigator.
A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy

The objectives of this trial are safety and efficacy (proof-of-concept) of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing TNFi treatment.

This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to achieve the similar exposures as the highest exposures tested and found safe and tolerable in preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help understand BI 655130's mode of action.


Eligibility Criteria:
Inclusion Criteria

* 18 - 75 years at screening and randomisation
* Diagnosis of ulcerative colitis \>= 5 months prior to screening
* Receiving TNFi treatment with doses (i.e. dose and dosing interval) unchanged for \>= 4 months (Infliximab) or \>= 2 Monaten (Adalimumab or Golimumab) prior to randomisation
* Mild or moderate disease activity, defined as total Mayo Score (MCS) (\<= 10)
* Further inclusion criteria apply

Exclusion Criteria:

* Prior use of more than two different TNF inhibitors or vedolizumab
* Extensive colonic resection
* Evidence of infection with C. difficile or other intestinal pathogen \<28 days prior to screening
* Active or latent tuberculosis
* Further exclusion criteria apply
Oral Health Care in Stroke Patients in Tertiary Care Hospital

To investigate oral care provision in stroke care settings in Pakistan. Stroke can have adverse effects on oral care and health. Little is known about current oral care practices in stroke care settings.

For a variety of related reasons, stroke can adversely affect oral care. Physical impairment, coordination, sensory or cognitive deficits may accompany a stroke and can impact on independent oral care. Post-stroke alterations in facial muscle mass or movement and sensory problems may result in poorly controlled dentures.

Dysphagia can contribute to oral care concerns in a number of ways. Oral intake of fluids may be restricted to reduce the risk of aspiration pneumonia, which in turn can contribute to xerostomia. Nutritional supplements, often prescribed, are high in sugar and may predispose to caries. Furthermore, because of swallowing impairment, pharmacological interventions are often administered in syrup consistency, which is sugar-based, and may also predispose to caries. Reduced swallowing ability causes ineffective clearance of bacteria and debris from the mouth leading to caries and infection.

Some pharmacological interventions in stroke care are known to have oral side effects. Oxygen therapy frequently administered in acute stroke management is known to cause mucosal drying and blistering. The absence of normal chewing patterns as a result of pain, physical or sensory impairment can also reduce salivary function. Xerostomia also causes pain, taste disturbance, chewing, and swallowing difficulties.

Speech and denture retention is also affected by inadequate saliva. This, in turn, increases plaque formation, predisposes to opportunistic oral infections, periodontal disease, and caries, conditions which place the individual at greater risk of pain, tooth loss and tooth substance loss. Chronic periodontal infection is currently being tentatively linked with the incidence of the stroke itself, while others have demonstrated a relationship with other systemic diseases including pneumonia and cardiovascular disease.

Healthcare-led oral care is a complex intervention and comprises a number of elements. These include assessment, accessing further assistance as required, and the use of appropriate equipment and cleaning methods. Knowledge is also required to assess and apply oral care at an individual level.

Eligibility Criteria:
Inclusion Criteria:

* Patient with diagnosed case of stroke
* Both gender will be included.

Exclusion Criteria:

* Patients with a known case of bleeding diathesis.
* patient not willing to participate
* patient with known head and neck cancer and oral pathology
Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

Women of reproductive age are considered a high-risk group for worm infections by the World Health Organization. Maternal infection and anemia contribute to infant malnutrition by affecting milk quality and quantity, and duration of exclusive breastfeeding. To date, no study has investigated the health benefits of postpartum deworming to infants or mothers. A randomized controlled trial will be conducted in Peru to investigate the effectiveness of integrating deworming into routine postpartum care. The primary measure of effect will be infant weight gain between birth and six months of age. Other infant and maternal health indicators will also be ascertained.


Eligibility Criteria:
Inclusion Criteria:

* Deliver at Hospital Iquitos
* Plan to reside in Iquitos or neighbouring area for the next 24 months
* Able to communicate in Spanish

Exclusion Criteria:

* Deliver multiples
* Delivery a stillborn or an infant with a serious congenital medical condition
* Transfered to another hospital prior to discharge
The Effect of Oral Bifidobacterium on Exogenous Creatine Absorption in Adult Subjects

The purpose of this clinical trial is to learn if Bifidobacterium has better antidepressant-like effects by enhancing creatine absorption in adults. The main questions to be answered are

Does Bifidobacterium combined with creatine have better antidepressant effects? Does Bifidobacterium enhance exogenous creatine uptake?

Researchers will compare bifidobacterium combined with creatine to creatine or bifidobacterium to see if bifidobacterium combined with creatine has better antidepressant effects.

Participants will:

Take bifidobacterium, creatine or placebo every day for 4 weeks. Keep a diary of their symptoms and collect blood samples.


Eligibility Criteria:
Inclusion Criteria for depression:

* Adults age 18-60 years inclusive.
* Current diagnosis of major depression disorder (MDD) identified by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (SCID-5).
* Current Hamilton Depression Scale 17 score of \> 16.
* BMI (body Mass Index) between 18 and 28 kg/m²
* Right-handed

Exclusion Criteria:

* Diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder, identified by the SCID-5.
* History of or current diagnosis of acute kidney injury (AKI), chronic kidney disease (CKD) or end-stage renal disease (ESRD)
* History of seizure disorder
* Current serious suicide risk identified by the Columbia Severity Suicide Rating Scale
* Previous diagnosis of creatine deficiency syndrome or evidence of creatine deficiency syndrome
* Antibiotic use in last 30 days
* Probiotics use in last 30 days
* Positive pregnancy test
* Breastfeeding
A Study Of Ursolic Acid For Primary Sclerosing Cholangitis

This is an open-label, active treatment trial to determine the pharmacokinetics of orally administered ursolic acid and to assess the potential efficacy and safety of ursolic acid in subjects with primary sclerosing cholangitis (PSC).

In the first phase of this trial, 6 healthy subjects and 2 PSC subjects will assigned to ursolic acid taken orally as a single dose of 40 mg, 80 mg, and 120 mg to determine the optimal dose in humans.

The second phase of this trial will involve 20 PSC subjects assigned to treatment with daily oral ursolic acid at the dose determined to be optimal in the first phase of the study. The treatment will last for 24 weeks with an off-treatment follow up of 28 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 - 70 years of age
* PSC documented by typically cholangiogram findings of strictures and dilations with no evidence of a secondary cause of sclerosing cholangitis
* Serum alkaline phosphatase greater than 1.5 times the upper limit of the normal reference range at the UC Davis Health Systems Clinical Laboratory
* AST and ALT ≤ 10 x ULN
* Serum creatinine \< 2.0 mg/dL
* Mayo Activity Index of \< 2 (in those with ulcerative colitis or Crohn's colitis)
* Negative serum pregnancy test for female subjects of childbearing potential, agreement to use a highly effective method of contraception during heterosexual intercourse (females of childbearing potential), lactating females must agree to discontinue nursing before starting study treatment, and barrier contraception during heterosexual intercourse (males not vasectomized).

Exclusion Criteria:

* Pregnancy
* Hepatic decompensation defined as ascites (or use of diuretics), episodes of hepatic encephalopathy, variceal bleeding or an INR \> 1.2
* Positive HCV RNA or HBsAg, positive anti-mitochondrial antibody, alcohol consumption greater than 21oz/week for males or 14oz/week for females
* Clinically significant cardiac disease, history of cholangiocarcinoma, history of liver transplantation, history of cancers, other than non-melanomatous skin cancer, within 5 years prior to screening
* Ascending cholangitis within 60 days of screening
* Use of immunosuppressants including 6-mercaptopurine, azathioprine, methotrexate, mycophenolate mofetil, tacrolimus, cyclosporine, and anti-TNF or other biologics within 6 months of enrollment
* Use of antibiotics including vancomycin, metronidazole, or rifaximin within 60 days of enrollment
Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors

Knowing the impact that the use of ESL as adjunctive treatment of partial epilepsy has on cardiovascular risk factors measured by biochemical and ultrasound parameters compared with enzyme-inducing AEDs.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* patients definitively diagnosed Focal Epilepsy based on clinical criteria and additional tests.
* patients with stable and identifiable antiepileptic treatment during the last two years.
* patients according to the investigator are able to provide clinical data necessary for the development of the study
* Patients who signed informed consent

Exclusion Criteria:

* Patients who, according to their evolution and demands of clinical practice, their previous treatment has to be changed for this reason breach inclusion criteria and / or attachment to one of the study groups.
Rifaximin Predicts the Complications of Decompensated Cirrhosis

Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and increased intestinal permeability all leading to an increase in bacterial translocation and increased endotoxemia. Rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract. It has been suggested that oral prophylactic antibiotics or bowel decontamination might improve long-term outcomes in patients with cirrhosis. The aim of this study was to explore the suitable dose of rifaximin to alleviate endotoxemia and prevent the complications of advanced cirrhosis.

Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and increased intestinal permeability all leading to an increase in bacterial translocation and increased endotoxemia. Cirrhotics with bacterial translocation and endotoxemia manifest hemodynamic derangement with lower systemic vascular resistance, higher cardiac output, and lower mean arterial pressure. Moreover, endotoxins may increase portal pressure by increasing vascular resistance which may be promoted through the cytokine-stimulated intrahepatic release of endothelin and cyclo-oxygenase products.

Indeed, bacterial infections are common in cirrhotic patients and have approximately 30% mortality at one month and a further 30% mortality at 12 months as documented in a systematic review comprising almost 12 000 patients. It follows that altering gut flora to decrease endotoxin levels may lead to improved prognosis in cirrhosis. Rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract. It has been suggested that oral prophylactic antibiotics or bowel decontamination might improve long-term outcomes in patients with cirrhosis, not only by reducing the risk of infections but also by reducing hepatic vein pressure gradient (HVPG).

The aim of this study was to explore the suitable dose of rifaximin to alleviate endotoxemia and prevent the complications of advanced cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* Decompensated cirrhosis
* Child-Pugh B or C stage

Exclusion Criteria:

* severe complications of cirrhosis in the past one month.
* renal dysfunction.
* administration of antibiotics in the past two weeks.
* malignant tumors.
* HIV infection.
* severe heart and lung disease
* sensitivity to rifaximin
* Pregnancy and lactation woman
* Patients who have took part in other clinical trials in the past three months.
RCT of Mushroom Based Natural Product to Enhance Immune Response to COVID-19 Vaccination

This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), for use as an adjunct to vaccination for COVID-19 in a general population at the time of COVID-19 vaccination.

This is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of two polypore mushrooms, Fomitopsis officinalis and Trametes versicolor (FoTv), for use as an adjunct to vaccination for COVID-19 in a general population at the time of COVID-19 vaccination.

Fo and Tv have immunomodulatory properties which may increase antibody titers in response to vaccination more than vaccination alone. However, because they are also immunomodulatory - not purely immune-stimulating - they may have the added benefit of simultaneously decreasing vaccine-related side effects following COVID-19 vaccination.

The study aims to establish the safety and feasibility of the use of FoTv vs placebo; evaluate the effect on post-vaccination clinical symptoms, neutralizing antibody, and immune response in 45 total subjects

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for or planning on scheduling COVID-19 vaccination
* Age 18 years and older
* Willing to avoid alcohol, cannabis, and dairy products during the study product in-take period.
* Capable of documenting vitals, symptoms, and study product intake daily and communicating this information to the study team

Exclusion Criteria:

* Known liver disease (or diagnosis of cirrhosis)
* Known renal disease or acute nephritis.
* Pregnant or breastfeeding women
Duloxetine Compassionate Use in Patients Who Have Completed a Previous Neuroscience Duloxetine Clinical Trial

The primary objective of this study is to provide duloxetine to investigators for the treatment of patients who have previously participated in neuroscience duloxetine clinical trials and for whom effective alternative therapy is not available.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female outpatients at least 18 years of age who have previously participated in a Lilly sponsored neuroscience duloxetine clinical trial
* All females must have a negative urine pregnancy test at visit 1. Females of childbearing potential must agree to utilize medically acceptable and reliable means of birth control.
* Must sign the informed consent document

Exclusion Criteria:

* Have received treatment within the last 30 days with a drug except for duloxetine that has not received regulatory approval for any indication at the time of study entry
* In the opinion of the investigator, patient judged to be at serious suicidal risk.
* Serious or unstable hepatic or renal function or unstable narrow angle glaucoma.
* Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to visit 1 or potential to use a MAOI during the study or within 5 days of discontinuation of study drug.
* Any patient who previously experienced a serious adverse event while taking duloxetine unless approved by the Lilly Physician