cyrilzakka/clinical-trials huggingface dataset:
The Dual Impact of Cirrhosis on Transplantation for Hepatocellular Carcinoma：a Two-center Retrospective Cohort Study in China

Background: This study aims to investigate the correlation between cirrhosis and hepatocellular carcinoma (HCC) recurrence after Liver Transplantation.

Methods: The study retrospectively collected data enrolled from 519 HCC patients who underwent liver transplantation from two center(the First Affiliated Hospital, Zhejiang University School of Medicine and Shulan (Hangzhou) Hospital, January 2015 to December 2020), Based on important variables, 1:3 propensity score matching (PSM) were performed respectively.


Eligibility Criteria:
Inclusion Criteria:

The patients undergoing liver transplantation for HCC from January 2015 to December 2020.

Exclusion Criteria:

Re-transplantation or combined liver-kidney transplantation; incomplete laboratory or clinical data; death within 90 days.
Poststroke Fatigue - Developing and Testing a Program to Reduce and Cope With Fatigue

Fatigue is a common complaint after stroke, reported by 39-72% of patients. Poststroke fatigue is related to poor neurological recovery, low level of activities of daily living, decreased quality of life and may possibly affect the ability to return to work. Little is known about strategies addressing post-stroke fatigue and their effectiveness.

Aim: to develop, test and evaluate a health promotion program based on strategies addressing poststroke fatigue.

Fatigue is a common complaint after stroke, reported by 39-72% of patients. It has been shown that poststroke fatigue may be related to poor neurological recovery, low level of activities of daily living and decreased quality of life. However, little is known about strategies to address poststroke fatigue and the effectiveness of such strategies.

Objective The aim of the study is to develop a program based on strategies to address poststroke fatigue and to test and evaluate the program.

Material and Methods Intervention Mapping is the overall approach of the study. It describes a protocol for the development of theory- and evidence-based health promotion programmes.

Step 1) The program is developed based on a needs assessment. Existing knowledge about physical, psychosocial and environmental factors associated with poststroke fatigue is mapped in a literature review.

Step 2) The program will be tested in a pilot study (controlled trial). In addition to conventional treatment, the patients in the intervention group will participate in the program for a period of 12 weeks. The control group will receive conventional treatment only.

Step 3) Evaluation of the program: Primary outcome measure will be fatigue, measured on the Multidimensional Fatigue Inventory-20. Secondary outcome measures will be identified during the development of the program. Patients will be tested at baseline, after 3 months and after 6 months. The effect size in the pilot study will be assessed and will be used in order to estimate the required sample size for a large-scale randomized controlled trial on formally testing the efficacy of the program.

Eligibility Criteria:
Inclusion Criteria:

* Patients with first ever stroke
* \> 18 year
* Living in the area of Aarhus(intervention group) and patients living in the area of Holstebro (control group).
* Multidimensional Fatigue Inventory-20/Generel Fatigue \> 12.
* The patient must be able to give informed consent
* Walking without person support.
* Walking aids is accepted.

Exclusion Criteria:

* Neurological problems related to acute stroke(severe aphasia, decreased level of conscience or decreased attention)
* Other neurologic or psychiatric deseases (including dementia, non treated depression, misuse of alcohol eller medicin)
* Severe co-morbidity (including cancer, blindness or deathness)
* Not-danish speaking.
Reducing Sedentary Time in Patients With Mild Cognitive Impairment: The Take a STAND for Health Study

This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in patients with mild cognitive impairment. A 4-month parallel-group randomized controlled trial will be conducted aiming to investigate the feasibility and efficacy of a newly developed personalized intervention focused on replacing sedentary time with light-(or very light-) intensity physical activity in patients with mild cognitive impairment. Additionally, a sub-sample of patients will complete a randomised cross-over study aiming to unravel potential mechanisms underlying the metabolic, physiological and molecular effects of breaking up sedentary time with light-intensity physical activity versus carrying out the minimum amount of daily exercise at once and then remaining sedentary versus simply remaining sedentary throughout all sessions, in a well-controlled laboratorial condition.


Eligibility Criteria:
Inclusion Criteria:

* Middle-aged and older adults with mild cognitive impairment confirmed by a team of neurologists from the CEREDIC HC-FMUSP

Exclusion Criteria:

* Patients who spend less than 8 hours per day in sedentary time
* Patients who are physically active (more than 150 min/week of moderate physical activity, or more than 75 min/week of vigorous activity)
* Patients who are functional illiterates
* Patients with history or clinical diagnosis of neurological diseases
* Patients with severe psychiatric symptoms
* Patients taking antidepressants
* Patients with visual and/or hearing impairments that prevent participation
Determination of Pneumothorax Post Lung Biopsy

Bedside ultrasonography for detection of pneumothorax after transbronchial lung biopsies in lung transplant patients

The patients who undergo transbronchial forceps lung biopsies get a routine CXR after the biopsies are performed. The reason for CXR is to find out if pneumothorax occurred or not. CXR is required patient transportation and interpretation by the radiologist as well as time consuming. Instead, we are planning to perform bedside ultrasound to determine if pneumothorax occurred or not

Eligibility Criteria:
Inclusion Criteria:

* Any lung transplant patient who undergoes to bronchoscopic lung biopsy

Exclusion Criteria:

* Patients develop respiratory failure during the procedure
Host Response to Urinary Tract Infection in Women

This study is being done to identify those elements of the immune response that may predispose a woman to recurrent urinary tract infection. We suspect that lesser effectiveness of certain components of the host response will lead to recurrent urinary tract infection. We will also evaluate the role that the bladder reservoir may play in recurrent urinary tract infection.

Procedures subjects will undergo once they have read and signed the consent are:

Questions about their medical and sexual history and current symptoms of urinary tract infection. They will be asked to provide a clean catch urine sample. We will collect periurethral, vaginal and rectal swabs. Blood will collected. They will be given a diary to take home and record all episodes of sexual intercourse, contraceptive use, vaginal and urinary symptoms and medication use.

They will be given standard treatment for the current urinary tract infection. Follow-up visits will be scheduled 2 weeks,one month,two month and three month after initial visit.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-49 years
* Able to provide written informed consent
* diagnosis of acute cystitis with symptoms for fewer than 7 days

Exclusion Criteria:

* Not pregnant or planning pregnancy in next 3 months
* No chronic illness requiring medical supervision (e.g. diabetes mellitus)
* No known anatomic or functional abnormalities of the urinary tract
* No signs or symptoms suggestive of pyelonephritis (flank pain or tenderness, temperature over 100 degrees F, nausea or vomiting)
Umbilical Cord Mesenchymal Stem Cell Transplantation for Lupus Nephritis

To investigate the safety and efficacy of umbilical cord mesenchymal stem cell transplantation in patients with systemic lupus erythematosus (SLE) and lupus nephritis (LN).

Systemic lupus erythematosus (SLE) is a multisystem autoimmune disease. Lupus nephritis (LN) is one of the most serious complications of SLE. The current clinical treatments of LN mainly include steroids and immunosuppressive drugs, but drug side effects are obvious.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the 1997 American College of Rheumatology (ACR) classification criteria of SLE.
* age 18-60 years.
* of either sex and of any ethnicity.
* Lupus nephritis (LN) group: (1) Receiving more than 6 months of regular treatment, 24-hour urine protein ≥ 1.0 g, serum creatinine ≥1.5 mg/dL; (2) renal biopsy: class III, IV or V LN included, and class VI excluded.
* After conventional treatment (glucocorticoid therapy and immunosuppressive drugs) prior to grouping, SLEDAI scores ≥ 10.
* Receiving 12 months of treatment while using birth control.
* Provision of informed consent.

Exclusion Criteria:

* Poor blood pressure control by drug treatment (≥ 160/100 mmHg)
* Abnormal hepatic function (a 3-fold increase in alanine aminotransferase level relative to normal liver).
* Renal failure (glomerular filtration rate \< 15 mL/min/1.73 m2).
* Severe heart and lung failure, or injury to other important organs
* Uncontrollable infection.
* Having not taken biological agents for 6 months.
* Pregnant or lactating women, or those women who are trying to get pregnant or those men who are trying to make their partners pregnant.
A Study of LY3009104(Baricitinib) for Healthy Subjects

To evaluate the safety and tolerability of LY3009104 when given orally as single and multiple doses in Japanese healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females. Male subjects: Agree to use 2 forms of highly effective methods of birth control with female partners of childbearing potential for the specified duration. Female subjects: Females must not be pregnant, breastfeeding, or at risk to become pregnant during study participation. Female subjects of childbearing potential must test negative for pregnancy at screening and agree to use 2 forms of highly effective methods of birth control, or remain abstinent for the specified duration.
* Up to third generation Japanese, that is defined as all of the subject's biological grandparents are of exclusive Japanese decent and have been born in Japan.
* Are between the body mass index (BMI) of 18.0 and 30.0 kg/m², inclusive at screening.

Exclusion Criteria:

* Are subjects who have previously completed or withdrawn from this study or any other study investigating LY3009104, and received the study drug.
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
* Show evidence of significant active neuropsychiatric disease.
* Have current or recent history of herpes zoster or simplex in the last 90 days prior to randomization, or history of herpes zoster, such as disseminated herpes zoster involving multiple dermatomes, ocular involvement, including herpes zoster involving the ophthalmic branch of the trigeminal nerve.
* Have or have a history of rheumatoid arthritis.
* History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin.
* History of stomach or intestinal surgery, except that appendectomy and/or cholecystectomy will be allowed.
* Receipt of blood products within 2 months prior to study entry.
Cabazitaxel in Platinum Refractory Ovarian Cancer

Ovarian cancer patients are considered platinum refractory if their disease worsens during primary platinum treatment or if they have no effect of the treatment. This constitutes a major therapeutic problem and new treatment approaches are highly needed.

Cabazitaxel (Jevtana®) is a new taxane with effect in breast and prostatic cancer. In both tumors it has effect in patients refractory to taxotere. Consequently, it could be anticipated that cabazitaxel may have an effect in platinum refractory ovarian cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. Stages I-IV.
* Patients with refractory disease defined as progression or no change during primary treatment, as evaluated after 3 and/or 6 cycles of platinum/paclitaxel. Prior to inclusion, patients must have received platinum and paclitaxel as combination treatment.
* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or evaluable by Gynecologic Cancer Interest Group (GCIG) cancer antigen 125 (CA-125) criteria.
* Age ≥ 18 years.
* Performance stage 0-2.
* Adequate bone marrow function, liver function, renal function, and coagulation parameters (within 7 days prior to inclusion):

  1. Neutrophils (ANC) ≥ 1.5 x 10\^9/l
  2. Platelet count ≥ 100 x 10\^9/l
  3. Serum bilirubin ≤ 1.0 x upper limit of normal (ULN)
  4. Serum transaminase ≤ 2.5 x ULN
  5. Serum creatinine ≤ 1.5 ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)and patients with creatinine clearance \<60 mL/min should be excluded
* Written informed consent.

Exclusion Criteria:

* History of severe hypersensitivity reaction (≥grade 3) to taxol.
* History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs.
* Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P4503A4/5 (a one week wash-out period is necessary for patients who are already on these treatments).
* Neuropathy grade ≥ 2.
* Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.
* Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.
* Other malignant diseases within 5 years prior to inclusion in the study, except basal cell or squamous cell carcinoma of the skin and cervical carcinoma-in-situ.
* Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.
* History of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the investigator may increase the risks associated with study drug administration. (e.g. diabetes, cardiac diseases, hypertension, renal, thyroid or liver disease).
* Vaccination with yellow fever vaccine or any live attenuated vaccine during the treatment.
* Treatment with disulfiram (antabuse)
Irradiation of Melanoma in a Pulse

This is a single center phase I, first-in-human, dose escalation study of FLASH therapy in patients with metastases of melanoma.

The trial is based on escalating single doses of FLASH therapy administered to skin melanoma metastases using the Mobetron® with high dose rate (HDR) functionality.

The aim of the study is to evaluate a dose escalation of high dose rate radiotherapy (FLASH therapy) as single dose treatment for skin melanoma metastases that progress locally despite systemic treatments. Melanoma is a typically radio-resistant tumor type, which can justify such a dose escalation with a new type of radiotherapy that appears much better tolerated than conventional radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Signed study Informed Consent Form
2. Karnofsky Performance Status (KPS) ≥ 50
3. Age ≥ 18 years
4. Patients with metastatic melanoma and multiple skin metastases with a documented clinical progression despite the systemic treatments (chemotherapy, and/or Programmed cell death 1 (PD1), cytotoxic T-lymphocyte antigen-4 (CTLA4) inhibitors or tyrosine kinase inhibitors (TKIs), such as v-raf murine sarcoma viral oncogene homolog B1 (BRAF) or mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors)
5. The size of the treated lesions should be ≤ 5.5 cm in diameter and ≤ 2.8 cm thick (caliper-based measurement)
6. The treated lesions should be at least 5 cm apart and must not be located on the face.
7. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (urine or serum) during screening
8. WOCBP must use a contraceptive method

Exclusion Criteria:

1. Previous radiotherapy in the treated area
2. Concomitant auto-immune disease with skin lesions
3. Concomitant use of radio-sensitizer drug
4. Women who are pregnant
5. Current, recent (within 10 days prior start of study treatment), or planned participation in an experimental drug study. During the 4 weeks DLT period, the patient will not be able to participate to any other clinical study.
6. Any serious underlying medical condition that could interfere with study treatment and potential adverse events
7. Any mental or other impairment that may compromise compliance with the requirements of the study
Supporting Prescribing in Irish Primary Care: General Practice Pharmacist Study

The aim of this pilot study is to develop and test an intervention (defined as the General Practice Pharmacist \[GPP\] intervention) involving pharmacists working with General Practitioners (GPs) to optimise prescribing in Ireland. The study will determine the costs and potential effectiveness of the GPP intervention and, through engagement with key stakeholders, will explore the potential for an RCT of the GPP intervention in Irish general practice settings.

Improving the quality and safety of prescribing for people with multiple chronic conditions and multiple medicines is a challenge for General Practitioners (GPs) and consequently, there has been an increased emphasis on ways to support GPs throughout this process. The integration of pharmacists into the general practice team is one approach being explored internationally and studies have shown that pharmacists, working as part of the general practice team, have influenced the safety and quality of prescribing. However, the evidence base is weak as there have been few high quality randomised controlled trials (RCTs) conducted and a range of modest effect sizes reported. Moreover, it is unclear whether such interventions can result in clinically significant improvements in patient outcomes. In Ireland, pharmacists are not integrated into general practice teams, therefore the feasibility of the integration of pharmacists into general practice warrants further exploration in the Irish primary care setting, prior to evaluation in a full scale RCT. The aim of this study is to develop and pilot test an intervention involving pharmacists, working within GP practices, to optimise prescribing in Ireland, which has a mixed public and private primary healthcare system.

Eligibility Criteria:
Inclusion Criteria for primary care practices:

* ≥1000 older patients (aged ≥65 years) on their patient panel.

Inclusion criteria for patients:

* Aged ≥65 years
* Taking ≥10 repeat medications
* Able to attend their primary care practice and participate in data collection.

Exclusion Criteria for patients:

* Psychiatric or psychological morbidity or cognitive impairment sufficient to impair the provision of informed consent
* Life-limiting illness likely to lead to death or major disability during the study follow-up period
* Patients who have already had a medication review/interacted with the pharmacist during the study period
A Clinical Research on the Relation of Blood Drug Concentration and Calcium Folinate Rescued in High-dose MTX Therapy

At present, the most effective drugs to osteosarcoma include ADM,DDP,,HD-MTX,IFO and so on.The effective rate of single drug was about 30%, and if the chemotherapy contains HD-MTX, the survival rate can reach about 60%, so the HD-MTX is the most important component in patients of osteosarcoma.

Studies have shown that, MTX efficacy and adverse reactions were associated with blood concentration level and duration, selecting the right time and dose to give CF is the critical point.


Eligibility Criteria:
Inclusion Criteria:

1. Proved by pathology in 60 cases of osteosarcoma patients
2. PS ≤ 2, survival period is more than 6 months
3. Normal function of liver and kidney
4. No chemotherapy contraindication, patients treat with high dose methotrexate
5. Get signed written informed consent form
6. Have a good compliance with take blood and follow-up

Exclusion Criteria:
Clinical Prediction Model and External Validation of Chronic Postsurgical Pain in Elders

This study will collect perioperative pain-related data of elderly patients in multi-centers. Analyzing these collected data to find the high-risk factors of chronic postsurgical pain in elderly patients and to establish an early-warning models of perioperative pain in elderly patients, so as to improve the ability of assessing the risks of postoperative pain in elderly patients and providing an early warning.

Based on the database, the investigators intend to explore:

* Perioperative risk assessment methods and early warning models for elderly patients;
* Practical, safe, and effective risk prevention and control system through subsequent studies.

This study will collect perioperative pain-related data of elderly patients in multi-centers, including: preoperative general data, intraoperative anesthesia and surgical data, clinical laboratory data, postoperative pain and intervention, postoperative complications and quality of life. Analyzing these collected data to find the high-risk factors of chronic postsurgical pain in elderly patients and to establish an early-warning model of chronic postsurgical pain in elderly patients, so as to improve the ability of assessing the risks of chronic postsurgical pain in elderly patients and providing an early warning.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chronic postsurgical pain (CPSP) CPSP was made based on the guidelines of the International Society for Pain (CPSP: ICD-11) as follows: Chronic postsurgical pain is chronic pain developing or increasing in intensity after a surgical procedure and persisting beyond the healing process, i.e. at least 3 months after surgery. The pain is either localised to the surgical field, projected to the innervation territory of a nerve situated in this area, or referred to a dermatome (after surgery/injury to deep somatic or visceral tissues). Other causes of pain including infection, malignancy etc. need to be excluded as well as pain continuing from a pre-existing pain problem. Dependent on type of surgery, chronic postsurgical pain often may be neuropathic pain.
* Geriatric surgical patients ≥65 years old

Exclusion Criteria:

* Patients in the central nervous system group were excluded from cardiac and neurosurgery, patients in the heart injury group were excluded from cardiac surgery, and patients who did not agree to participate in the study were excluded in all groups.