cyrilzakka/clinical-trials huggingface dataset:
Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment

Combination of gemcitabine-cisplatin was one of the most effective chemotherapy treatment in mesothelioma patients. However, median survival of this patient group was only about 12 months. With intent to find more effective treatment the investigators performed phase II study with gemcitabine in low dose (130-250 mg/m2) in 6-hours (prolonged) infusion in combination with cisplatin in advanced non-small cell lung cancer (Zwitter et al. Anticancer Drugs 2005;16:1129-34). After favourable experience, the investigators decided to explore such regiment in patients with malignant pleural mesothelioma (MPM) as well.

The purpose of this study is to evaluate new regimen of treatment for its activity in malignant pleural mesothelioma (MPM). The primary objectives of the trial are assessing the treatment toxicity, response rate, and progress free survival; secondary objectives are assessment of overall survival and quality of life.

Inclusion criteria:

* Biopsy-proven diagnosis of MPM
* Inoperable for anatomic or physiological reason
* Measurable and previously unirradiated lesion
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2
* Adequate haematopoietic, liver, and kidney function.
* Signed informed consent for participation in the trial

Exclusion criteria:

* Significant medical co-morbidity
* Pregnant or lactating women
* History of the cancer in the previous 10 years or breast cancer ever.

The general treatment schedule will be identical for all patients: gemcitabine in 6-hours infusion on days 1 and 8, and cisplatin at 75 mg/m2 on day 2 of a 3-weekly cycle with standard antiemetic treatment using metoclopramide, dexamethasone, aprepitant, and granisetron. After 4 cycles, patients not in progression and without serious toxicity continued with additional 2 cycles of monotherapy with gemcitabine in prolonged infusion.

National Cancer Institute Common Toxicity Criteria (NCI CTC), version 2.0 will be used for grading the toxicity. In the day of administration of the cytotoxic drug complete blood cell count and chemistry panel will be performed, and the treatment will be reduced or avoided in the event of bone marrow suppression or decline in renal clearance. In cases of Grade I (NCI CTC, vs. 2.0) neutropenia and/or thrombocytopenia, the dose of gemcitabine will be reduced to 75%; the drug will be omitted with Grade II or greater neutro/thrombocytopenia. Cisplatin will be omitted in cases of Grade ≥ II nephrotoxicity and/or grade III nausea or vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven diagnosis of malignant pleural mesothelioma
* Inoperable for anatomic or physiological reason
* Measurable and previously unirradiated lesion
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2
* Adequate haematopoietic, liver, and kidney function.
* Signed informed consent for participation in the trial

Exclusion Criteria:

* Significant medical co-morbidity
* Pregnant or lactating women
* History of the cancer in the previous 10 years or breast cancer ever.
Comparison of Different Glucose Concentrations in Dialysate of Hemodialysis Patients

This study aims to show that using a glucose (sugar) concentration of 100 mg/dL in the dialysis fluid for hemodialysis is not inferior to using a concentration of 200 mg/dL with regard to the frequency and magnitude of blood glucose drops. Other parameters that will be compared between the two groups are blood pressure, heart rhythm, weight gain between dialysis treatments, and fatigue after the treatment.

This is a prospective, randomized, single-blinded cross-over non-inferiority trial of intra- and early post-dialytic glucose homeostasis comparing 100 mg/dL against 200 mg/dL dialysate glucose concentration in 30 hemodialysis patients. The primary outcome is the frequency and magnitude of hypoglycemia during and early after the hemodialysis treatment. Secondary outcomes include intradialytic blood pressure, interdialytic weight gain, serum potassium and phosphorus concentrations, arrhythmias during dialysis and in the early postdialytic period, and postdialytic fatigue.

Inclusion criteria:

Age ≥ 18 years

Maintenance hemodialysis with hemodialysis vintage of at least 30 days

Ability to read and understand the English language and give informed consent

Exclusion criteria:

Dialysis treatment frequencies other than three times per week

Hospitalizations or antibiotics-dependent infection during the 8 weeks preceding enrollment

Central venous catheter as hemodialysis access

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Maintenance hemodialysis with hemodialysis vintage of at least 30 days
* Ability to read and understand the English language and give informed consent

Exclusion Criteria:

* Dialysis treatment frequencies other than three times per week
* Hospitalisations or antibiotics-dependent infection during the 8 weeks preceding enrollment
* Central venous catheter as hemodialysis access
The Open Kinetic Chain and Closed Kinetic Chain Strengthening Exercises in Degenerative Meniscus Tears

This randomized-controlled trial aims to compare the effect of open kinetic chain and closed kinetic chain strengthening exercises on pain, function, and health-related quality of life in degenerative meniscus tears.

Patients with degenerative meniscus tears between the ages of 40 and 65 will be randomly divided into two groups: Group 1 (open kinetic chain strengthening exercises) and Group 2 (closed kinetic chain strengthening exercises). Interventions will be applied for 16 sessions (twice a week for 8 weeks). The patients will be assessed at baseline and at the end of the 8-week intervention. The pain during activity, at rest, and at night will be assessed with the Visual Analog Scale (VAS). Active range of motion will be assessed with a digital goniometer. Isometric muscle strength will be measured with a handheld dynamometer. The functional status and symptoms will be evaluated by the Knee Injury and Osteoarthritis Outcome Score (KOOS) and Lysholm Knee Scoring Scale. Health-related quality of life will be assessed with the Short Form-12 (SF-12).

Eligibility Criteria:
Inclusion Criteria:

* Being aged between 40 and 65 years
* Having the degenerative meniscus tear in at least one knee
* Having body mass index in the range of 18-30 kg/m2
* Feeling the pain that lasts for at least 2 months
* Having grade 1 or grade 2 degenerative meniscal tear diagnosed by an orthopedic specialist according to the MRI results
* Having the ability to read and write Turkish

Exclusion Criteria:

* Having undergone arthroscopic partial meniscectomy surgery due to degenerative meniscal tear
* Participating in a physiotherapy program for degenerative meniscal tear in the last 12 weeks
* Have received steroid injections in the last 6 months
* Accompanying conditions such as injury to the surrounding ligaments, congenital anomaly in the affected knee, coxarthrosis and spinal stenosis
* Presence of any systemic disorder that may affect assessment parameters
* Failure to cooperate with assessments
Incidence of Hepatitis B Virus (HBV) Reactivation in HBsAg Negative/HBcAb Positive Lymphoma Patients Treated With RCHOP

The aim of this study is to identify the incidence of hepatitis B virus reactivation rate in Diffuse Large B Cell or high grade Follicular lymphoma patients with prior resolved hepatitis B undergoing RCHOP immuno-chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Naive DLBCL or high grade FL patients
* Age range 18-75 years old
* ECOG performance status 0-3
* Life expectancy of more than 3 months
* Adequate organ function
* HBsAg negative/HBcAb positive at baseline

Exclusion Criteria:

* Infection of HAV,HCV,HIV
* Pregnant or lactating women
* Serious uncontrolled diseases
Oxford Ovarian Cancer Predict Chemotherapy Response 01

The purpose of the study is to understand why there are differences between individuals in the way they respond to paclitaxel chemotherapy.

While paclitaxel is very effective in killing cancer cells in a proportion of patients, some patients don't respond to this treatment. As with any chemotherapy, paclitaxel is associated with unpleasant side effects. We are doing this study to try and understand what is happening in cancer cells in different individuals after paclitaxel treatment that make them respond differently to the same treatment. We hope that this study will enable us to develop a method to identify women who are suitable for this form of treatment. We also want to understand why some cancer cells don't get killed with paclitaxel. This information will help us to select treatment to suit an individual patient, and thus improve the outcome of treatment and avoid giving treatment that will not benefit the patient.

Eligibility Criteria:
Inclusion Criteria:

* Female ≥ 18 years of age
* Newly diagnosed and histology confirmed primary high grade serous ovarian cancer, high grade serous fallopian tube cancer and primary peritoneal carcinoma.
* Radiological and laparoscopic confirmation of FIGO stage 3C or 4 ovarian cancer.
* Radiological evidence of omental or peritoneal deposits that are accessible for radiology-guided biopsy.
* At least one lesion on CT scan measuring at least 2 cm in maximum diameter performed in the past 31 days. Slightly older scans may be accepted at the discretion of the CI providing the results are considered to remain clinically relevant.
* Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
* Life expectancy of at least 6 months.
* The patient is willing and able to provide written informed consent and comply with the protocol for the duration of the study, and scheduled visits and examinations.
* Acceptable haematological and biochemical indices

Exclusion Criteria:

-
Third Optimizing Anti-Platelet Therapy in Diabetes MellitUS (OPTIMUS-3)

This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers. The study will compare platelet function following a prasugrel loading dose and 1 week of prasugrel maintenance therapy with high-dose clopidogrel loading dose and 1 week of high-dose clopidogrel maintenance therapy in patients with drug treated type 2 diabetes mellitus who have coronary artery disease. Various assays of platelet function will be used in this study. Platelet function will be studied using the following assays: Accumetrics VerifyNowTM P2Y12, Light Transmittance Aggregometry (LTA), Vasodilator-associated stimulated phosphoprotein (VASP), and Thromboelastography (TEG)-platelet mapping.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus and on oral or parenteral hypoglycemic therapy for at least 1 month.
* History of Coronary Artery Disease with or without other types of vascular disease (such as peripheral vascular disease).
* Taking Aspirin 75-325 mg/day for at least 1 week prior to randomization.
* Between the ages of 18-74 years old.
* If a woman of child bearing age, must not be pregnant and must agree to use reliable method of birth control during the duration of the study.

Exclusion Criteria:

* Thienopyridine therapy within 30 days or have a defined need for thienopyridine treatment.
* Coronary Artery Bypass Graft (CABG) or Percutaneous Coronary Intervention (PCI) with no stent placed within 30 days.
* Planned coronary revascularization
* Hemoglobin A1c (HbA1c) \> or equal to 10 mg/dL within the last 3 months.
* Received fibrolytic therapy \<24 hours prior to randomization.
* Received non-fibrin-specific fibrinolytic therapy \<48 hours prior to randomization.
* At risk of bleeding.
* History of ischemic stroke, transient ischemic attack (TIA), intercranial neoplasm, arteriovenous malformation, or aneurysm.
* Body weight \<60 kilograms (kg).
* International Normalized Ratio (INR) \>1.5, platelet count \<100,000/mm3, or anemia (hemoglobin \<10 gm/dL) within 1 week of study entry.
* Are receiving or will receive oral anticoagulation or antiplatelet treatment therapy.
* Are being treated with daily non-steroidal anti-inflammatory drugs (NSAIDS).
* Are pregnant, breast-feeding or plan to become pregnant.
Detection of Sinusoidal Obstruction Syndrome With Ultrasound After Allogeneic HSCT

We would like conduct a retrospective study in our center to evaluate the early detection of sinusoidal obstruction syndrome with hepatic ultrasound after allogeneic hematopoietic stem cell transplantation.

The diagnosis of sinusoidal obstruction syndrome also know as veno-occlusive disease is often difficult. This is a potentially life-threatening complication that can develop after allogeneic hematopoietic stem cell transplantation. Clinically, sinusoidal obstruction syndrome is charaterized by hepatomegaly, right upper quadrant pain, jaundice and ascites. The diagnosis is based on biological parameters (bilirubin increase ≥ 2mg/dL or 34.2µmol/L) and clinical evaluation (sodium fluid retention with weight gain \> 5%, ascites, painful hepatomegaly) (reference : M. Mohty and al. Revised criteria for sinusoidal obstruction syndrome, Bone Marrow Transplantation (2016) 906-912).

Early therapeutic intervention is pivotal for survival in sinusoidal obstruction syndrome, thus a rapid and reliable diagnosis has to be made. To rule out major differential diagnosis, a reliable imaging method is needed. In practice, doppler ultrasonography, is helpful to detect hepatomegaly and ascites but also is an help to explore well defined criteria of sinusoidal obstruction syndrome already published. For sonography criteria: hepatomegaly (3 measures) with an increase of 2cm versus baseline, gallbladder wall thickening, ascites or 3 criteria of a native VOD; splenomegaly, increase of the portal vein diameter, decrease of the hepatic vein diameter, visualisation of the para umbilical vein and for the doppler : increase of the hepatic artery RI (\>0.75), monophasic flow in the hepatic veins (venous retraction is very typical but very late), flow demodulation on portal vein, decrease in portal flow, portal flow congestion, reversed flow, flow recorded in the para-umbilical vein ; all five last signs are late (reference : Lassau N. et al Prognostic value of doppler ultrasonography in hepatic veno occlusive disease. Transplantation 2002 jul 15 ;74(1) :60-6). These criteria can confirm the diagnosis : 6 signs of wich the first 3 can affirm the diagnosis with certainty in combination with clinical and biological parameters. There is currently a few data in the literature about early detection of this complication with systematic ultrasound. In this study, we want to evaluate in a retrospective study the interest of this technique in the early and systematic detection of sinusoidal obstruction syndrome.

Eligibility Criteria:
Inclusion Criteria:

* all adult patients with allogeneic hematopoietic stem cell transplantation in Nancy University Hospital between Sep 2016 and Sep 2018

Exclusion Criteria:

* age \< 18 years old
Long-term Outcomes of Patients With Primary Amyloidosis After Stem Cell Transplantation

This study examines the value of stem cell transplantation in managing light chain amyloidisis.

1. How does age at diagnosis affect prognosis in primary amyloidosis?
2. How do lab values at diagnosis such as Creatinine, AST/ALT, total serum protein, serum gamma globulin/immunoglobulin levels affect prognosis in primary amyloidosis?
3. How does degree of organ involvement/number of organs involved affect prognosis in primary amyloidosis?
4. How does initial treatment affect prognosis in primary amyloidosis?

4. How do the specifics the stem cell transplant protocol affect prognosis in primary amyloidosis?

Eligibility Criteria:
Inclusion Criteria:

* Eligible for Stem cell transplantation less than age 75

Exclusion Criteria:

* Creatinine \> 3.0
* BNP \> 10000
Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study

This study assesses the feasibility, and acceptability of a (mobile) application for men presenting at their physician's office with LUTS/BPH; starting with medical therapy and naïve for treatment. Patients will be enrolled in the study by their physician (GP or urologist). The patients will receive a daily medication reminder including frequent feedback on medication adherence. Furthermore, standard questionnaires will be filled out via the application. The hypothesis of this pilot study is that application is feasible and accepted in this group of patients.

Rationale:

One of the next developments in healthcare is digitalization, including (mobile) applications that could support healthcare providers. A significant number of aging men suffer from lower urinary tract symptoms (LUTS), often caused by benign prostate hyperplasia (BPH). LUTS/BPH is primarily treated by physicians (GPs or Urologists). Optimal evaluation of patients with LUTS/BPH, treatment selection and follow-up by the physicians and medication adherence are essential in the management of LUTS. This pilot project represents a strong collaboration between a urological association, urologists, and physicians in supporting healthcare improvement for LUTS/BPH with the use of a (mobile) application. The hypothesis is that the (mobile) application can support the patient in medication adherence and improve the adherence by feedback and that the application can help to collect objective disease information with electronic questionnaires.

Objectives:

The primary objective is to assess the feasibility, and acceptability of a (mobile) application for men presenting at their general practitioner/or urologist with LUTS/BPH who are either: under treatment, or who may require medical therapy for the first time.

The secondary objectives are to identify potential gaps, clarify controversial points of the application, to document the communication between patients, physicians and supervising urologists in order to optimize (if necessary) the application, to assess medication adherence and to record if treatment provided by physicians is in compliance with the guidelines recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age ≥ 40
* Bothersome LUTS
* Start of medical therapy for LUTS
* Either:

  1. No previous LUTS/BPH treatment (medical or invasive), or
  2. Under medical treatment
* In possession of a smartphone, tablet or computer with internet connection
* Access to email
* Fluent speaking and reading of the national language
* Signed informed consent

Exclusion Criteria:

* Previous LUTS/BPH treatment with surgery
* Previous pelvic surgery or radiotherapy
* History of neurological disease
* History of bladder or prostate cancer
* Unable to provide informed consent
* Analphabet
* Unable to operate a smartphone/ tablet/computer
* Incapable of understanding the language in which the information for the patient is given
The Impact of Pharmaceutical Care Practice on Patients in Cardiac Rehabilitation Unit

This study aims to investigate the role of clinical pharmacist in the development of a pharmaceutical care program for patients with Acute coronary syndrome tailored to their specific learning needs and their cultural context, and to verify the program's effects on physiological factors and recurrent symptoms or cardiac events.


Eligibility Criteria:
Inclusion Criteria:

1. Are diagnosed with Acute coronary syndrome (ischemic heart disease) by their primary cardiologist, treated with medication, percutaneous coronary angioplasty, or coronary artery bypass graft.
2. At 20-79 years of age.
3. Has the ability to perform regular physical activity according to the patients' self-identification and the judgment of their primary cardiologist.
4. Willing to participate in this study.
5. Able to be reached by telephone postdischarge.

Exclusion Criteria:

1. Patients with cognitive impairment.
2. If they need professional help to take their medication at home.
3. With terminal illness.
4. Inability to communicate.
5. Severe arrhythmia.
Genetic Analysis for Predicting of Relapse During Steroid Treatment for Autoimmune Pancreatitis (AIP)

To determine whether certain alleles or haplotypes of major histocompatibility complex gene are associated with AIP in Korean population, we undertook this study with high-resolution typing for HLA (sequence-based typing).

Primary outcomes: detection of novel allele associated with AIP in Korean population Secondary outcomes: detection of genetic factor for relapse of AIP during steroid treatment

Autoimmune chronic pancreatitis (AIP) can be defined as a chronic inflammation of the pancreas due to an autoimmune mechanism; autoimmunity is responsible for producing the pancreatic lesion. AIP is a distinctive type of chronic pancreatitis that shows reversible improvement of pancreatic morphology and function with oral steroid therapy, in comparison to other types of chronic pancreatitis which hardly respond to various treatments. AIP is increasingly being recognized to be a worldwide entity. The sudden increment in cases reported probably reflects the growing awareness of the entity, rather than a rise in the true incidence. In previous Japanese report, HLA DRB1\*0405-DQB\*0401 haplotype may be associated with autoimmune pancreatitis in the Japanese population. However, to date there was no subsequent data for supporting these results. In addition, this Japanese study had a limitation in methodology by using a low-resolution typing for HLA. Although this entity is well responsive to steroid therapy, relapse of AIP during steroid treatment is not uncommon. Unfortunately, there has been no laboratory or genetic predictor for responsiveness to steroid therapy in patients with AIP. To further clarify and confirm high-risk and protective genotypes for autoimmune diseases, therefore, high-resolution typing for HLA should be needed. Thus, to determine whether certain alleles or haplotypes of major histocompatibility complex gene are associated with AIP in Korean population, we undertook this study with high-resolution typing for HLA (sequence-based typing).

Eligibility Criteria:
Inclusion Criteria:

* Patient with autoimmune pancreatitis
* The diagnosis is mainly based on the following three characteristic findings proposed by Japan Pancreas Society in 2002: (1)Imaging studies: irregular narrowing of the main pancreatic duct and diffuse enlargement of the pancreas, (2) Laboratory data: elevated serum IgG or the presence of autoantibodies, (3) Histological examinations: fibrotic changes with lymphoplasmacytic infiltration in the pancreatic tissue.
* Age 18 years and above
* No serious medical or psychological condition that would preclude study treatment
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

* Age below 18 years
* Pregnancy
* Active alcohol or drug abuse
* Unstable or unwilling to comply with follow up
Surgical Surveillance Trial to Evaluate a Shortened Infusion Time of Intravenous Ibuprofen

The primary objective of this study is to determine the safety of a single dose of intravenous ibuprofen administered over 5-10 minutes for the preemptive treatment of postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgery with anticipated need for postoperative analgesia

Exclusion Criteria:

1. Patients with inadequate IV access
2. Patients \<18 years of age
3. History or allergy or hypersensitivity to any component of intravenous ibuprofen, aspirin (or aspirin related products) or non-steroidal anti-inflammatory drug (NSAIDs)
4. Active hemorrhage or clinically significant bleeding
5. Pregnant or nursing
6. Patients in the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery
7. Inability to understand the requirements of the study, be willing to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions
8. Refusal to provide written authorization for use and disclosure of protected health information