cyrilzakka/clinical-trials huggingface dataset:
Study of MLN4924, a Novel Inhibitor of Nedd8 Activating Enzyme, in Adult Patients With Lymphoma or Multiple Myeloma

This is an open-label, multicenter, phase 1, dose escalation study of MLN4924 in adult patients with lymphoma or multiple myeloma. The patient population will consist of adults with a confirmed diagnosis of lymphoma (Waldenstrom's macroglobulinemia is permitted) or multiple myeloma that is relapsed and/or refractory after at least 2 prior standard chemotherapeutic regimens and for which no curative option exists.

Patients in the expansion cohort, Schedule E, must specifically have Hodgkin lymphoma, DLBCL-GCB subtype, DLBCL-non-GCB subtype, or Mantle Cell Lymphoma (MCL). Patients with multiple myeloma will no longer be evaluated as a part of this study.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Patients must have a confirmed diagnosis of lymphoma (Waldenstrom's macroglobulinemia is permitted) or multiple myeloma that is relapsed and/or refractory after at least 2 prior standard chemotherapeutic regimens and for which no curative option exists.

  1. As of Protocol Amendment 7, patients in the expansion cohort, Schedule E, must specifically have Hodgkin lymphoma, DLBCL-GCB subtype, DLBCL-non-GCB subtype, or Mantle Cell Lymphoma (MCL). Patients with multiple myeloma will no longer be evaluated as a part of this study.
* Tumor that is evaluable by radiography, serum or urine electrophoresis (for patients with multiple myeloma), or clinical evaluations.

  1. As of Protocol Amendment 7, tumor that is evaluable by radiography or clinical evaluations.
* Suitable venous access for the conduct of blood sampling for MLN4924
* Adequate Organ Function

Exclusion Criteria:

* Systemic antineoplastic therapy within 21 days preceding first dose of study treatment, or rituximab therapy within 2 months preceding first dose of study treatment (unless there was evidence of PD since their last dose of rituximab).
* Treatment with corticosteroids within 7 days preceding first dose of study treatment.
* Prior treatment with radiation therapy involving \>25% of bone marrow; Any radiotherapy within 14 days before first dose of study treatment.
* Treatment with CYP3A inducers within 14 days before the first dose of MLN4924. Moderate and strong CYP3A inhibitors and CYP3A inducers are not permitted during the study.
* Patients requiring Coumadin who cannot be switched to a low molecular weight heparin should not be considered for this study.
* Absolute neutrophil count less than 1,000/mm3; platelet count less than 75,000/mm3.
* Calculated creatinine clearance less than or equal to 50 mL/minute.
Effects of Deep Breathing Excer. With & Without PMR on Post C Section LBP, QOS & PA

To find out the Effects of deep breathing exercises with and without Progressive Muscle Relaxation Technique on Post Cesarean Section low back Pain, Quality of Sleep and Physical Activity


Eligibility Criteria:
Inclusion Criteria:

* Females who had caesarian section
* Age 20-35 years
* No contraindications to exercise stated by an obstetrician

Exclusion Criteria:

* Females having heart disease,
* Females with Diabetes mellitus,
* Pre-eclampsia or eclampsia
* Complications during the operation
* Diseases of the nervous system, e.g. MS, stroke, Respiratory diseases, Diabetes, Cancer \&rheumatic diseases
Pharmacogenomics Studies of Antidepressants

The purpose of this study is to establish the clinical effectiveness of antidepressants by pharmacogenomic approach, and to determine the levels of inflammatory factors between the baseline and the end point of the study in Taiwanese major depressive disorder (MDD) patients.


Eligibility Criteria:
Inclusion Criteria:

* Age: 16-65 years old
* Signed informed consent by patient or legal representative
* Hamilton Rating Scale for Depression (HDRS) scores ≥ 16
* A diagnosis of MDD according to DSM-IV criteria made by a specialist in psychiatry

Exclusion Criteria:

* monoamine oxidase inhibitor or antidepressant treatment within two weeks prior to entering the study
* A DSM-IV diagnosis of substance abuse within the past three months
* An organic mental disease, mental retardation or dementia
* A serious surgical condition or physical illness
* Patients who were pregnant or breastfeeding
Compass Device CVC Trial

This is a single-arm observational trial of a device (Compass Vascular Access, Centurion Medical Products, Williamston MI). The device is a compact, sterile, single-use extravascular blood pressure transducer. This pressure measurement aids in confirmation of appropriate venous access. The investigators plan to enroll 40 consenting patients with BMI ≥35 who require central venous catheterization for clinical reasons independent of the existence of this study. The primary outcome is operator satisfaction.

Forty (40) consenting patients meeting inclusion/exclusion criteria for this single-arm observational trial will be prepared as usual for central venous catheter (CVC) placement. The Compass pressure measurement device will be included in the CVC placement apparatus as per the manufacturer's directions. Data will be recorded on the placement procedure, operator satisfaction, routine patient demographics, and incidence of inadvertent arterial puncture.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥35

Exclusion Criteria:

* Pregnant women
* Adults unable to consent
* Non-English speakers
* Prisoners
Explainable Machine Learning for the Assessment of Donor Grafts in Liver Transplantation

Clinically, organ evaluation generally performed by the senior surgeons based on their experience and the visual and tactual inspection of the graft during procurement. However, it is proved that transplant surgeons intuition in the evaluation of donor risk and the estimation of steatosis is inconsistent and usually inaccurate. Besides, graft assessment is a dynamic process refer to amount of complex factors, which is considered to be an incredibly complicated relationship that is nonlinear in nature. Unfortunately, the classical statistic techniques in vogue such as multiple regression require the statistical assumption of independent and linear relationships between explanatory and outcome variables, and fail to analyse a large number of variables. We attempted to develop liver graft assessment models by predicting postoperative DGF using several ML techniques. Secondly, the best prediction model was selected by comparing the performance of different AI algorithms and logistic regression. Finally, we sought to explain the decision made by AI algorithms using a visualization algorithm based on the best prediction model, helping clinicians evaluate specific organ and whether to receive that may develop DGF postoperatively.


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years-old
2. Underwent deceased donor liver transplantation

Exclusion Criteria:

1. Underwent living-donor LT;
2. Missing rates of data were more than 80%
Gemcitabine and Pemetrexed in Primary Unknown Adenocarcinoma

There is no standard treatment for the patient population being asked to participate in this study. Although one current regimen, used by some investigators, has a high rate of response compared to other therapies, it is associated with moderate to severe toxicity. As gemcitabine and pemetrexed have a broad range of activity against cancer it is reasonable to determine how active and safe they are against patients with this type of cancer.The objective of this study is to determine the anti-tumor activity of pemetrexed and gemcitabine in patients with this condition.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma
* No obvious primary on routine history, physical examination, and investigations
* Patients greater than or equal to 18 years of age
* ECOG Performance Status 0-1
* Patients requiring opioids for pain control must be on a fixed analgesic regimen aimed to provide adequate pain control with no more than 3 breakthrough (supplemental) doses of analgesics per day to control pain; Additional inclusion criteria due apply, but not are not listed here.

Exclusion Criteria:

* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Unable to stabilize pain and analgesics for a period of 7 days prior to starting study treatment
* Prior treatment with chemotherapy
* Bilirubin greater than or equal to 40 mol/L
* AST or ALT greater than or equal to 5 times the upper limit of normal (ULN); Additional exclusion criteria due apply, but not are not listed here.
Prediction and Prognostic Analysis of Liver Abscess Formation After Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma (CHANCE 2407)

Liver abscess is a rare but serious complication of hepatocellular carcinoma after TACE, with an incidence of less than 1% reported in previous literature. Studies have shown that history of biliary tract disease, tumor size, embolization materials and embolization endpoint selection may be related to the occurrence of abscess. In recent years, with the wide application of targeted and immune drugs, there have been reports of multiple cases of liver abscess after single target immunotherapy for liver cancer, and there have also been studies showing that TACE combined with targeted immunotherapy can significantly increase the degree of liquefaction necrosis and increase the risk of liver abscess. However, these studies are single-center reports with small sample size and low level of evidence. Therefore, it is of great clinical significance to explore the risk factors of liver abscess after TACE and build a prediction model by using multi-center and large sample data. The formation of liver abscess after TACE means a large range of tissue liquefaction necrosis. There are reports of high incidence of early recurrence and metastasis of liquefaction necrosis. Some studies also show that tumor necrosis is more complete when liver abscess is combined with complete remission. In previous studies, ORR in patients with liver cancer complicated with liver abscess ranged from 18.75%-100%, with significant differences in reports from different centers. The effect of specific abscess formation on TACE efficacy of liver cancer remains to be determined. Therefore, the second research focus of this project is to explore the effect of liver abscess formation after TACE on prognosis of liver cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Case group inclusion criteria:

   1. Time period of inclusion: 2009-2023 (15 years)
   2. Patients with HCC diagnosed by clinical or pathological criteria according to the National Health Commission guidelines for the diagnosis and treatment of primary liver cancer who underwent TACE after surgery and developed postoperative liver abscess.
   3. Appendix: Diagnostic criteria for liver abscess after TACE:

   Condition 1: CT images show typically low-density lesions with or without air and fluid levels

   Condition 2:
   * positive blood culture
   * Percutaneous drainage or aspiration is purulent or culture-positive
   * Symptoms of infection such as fever/chills, accompanied by elevated inflammatory markers such as white blood cell count, C-reactive protein, or procalcitonin.
2. Control group inclusion criteria

   1. Patients with HCC without liver abscess who underwent TACE in the same center within the week of treatment in the case group.

      -

      Exclusion Criteria:

   <!-- -->

   1. Clinical and follow-up data were incomplete
   2. Loss to follow-up
Paricalcitol on Albuminuria, Inflammation and Fibrosis on Proteinuric Chronic Renal Diseases (PALIFE Study)

The purpose of this study is to estimate the differences between albuminuria values determined as Urine Albumin-to-Creatinine Ratio (UACR)(log transformed) from baseline to last observation caused by paricalcitol between the group of control and group of treatment.

Clinical Trial to estimate UACR determined albuminuria differences between treatment and non-treatment groups from basal intake to last study-related observation. Patients should suffer proteinuric Chronical Kidney Disease and recovered levels of seric 25(OH)D. Also, this clinical trial tries to determinate the effect of paricalcitol over several metabolic and inflammatory parameters on patients.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed
* Patients will be men or women, between 18 and 75 years old.
* Patients must have been taken an stable dosis of Angiotensine Converter Enzyme Inhibitor, Angiotensine Receptor Antagonism or antialdosterone at last 6 months before screening visit.
* Patients should not be on dialysis treatment.
* Women should not be pregnant, or in fertile period (at last 1 year postmenopausal or chirurgic sterilized or using this contraceptive methods: condoms, gel, intrauterine devices, anticonceptives, etc. During at last 3 months after the study beginning.

Exclusion Criteria:

* Patients have taken active vitamin D during 6 months after the screening.
* Patients with allergy o sensibility to paricalcitol.
* Patients with acute CKD 12 weeks before the screening.
* Patients with chronical gastrointestinal disease.
* Patients with hypo or hyperthyroidism.
* Patients with secondary hypertension
* Bad controled hypertension patients
* Patients with renal lithiasis
* Patients with drug dependence
* Patients taking calcitonins, biphosphonates, cinacalcet or others Ca-metabolism drugs.
* Patients taking immunosuppressor drugs.
* Patients not adequate to study as medical opinion.
* HIV patients
* Seric P \> 5.0 mg/dl.
* Seric Ca\> 10,0 mg/dl.
* Proteinuria \> 3.500 mg/g
* Hypoalbuminemia \< 3g/dl
Audit of Bronchoscopy Practice in Egypt: Adherence to Safety and Infection Control Guidelines

Both patient and staff safety are of major importance during the procedure of fibreoptic bronchoscopy. Patient safety depends partly on adequate disinfection of instruments and accessories used as well as careful monitoring during the procedure.

Adequate facilities, manpower and training are also essential. Staff safety depends partly on adequate procedures to minimise any risks of sensitisation to agents such as glutaraldehyde. An audit well be carried out of bronchoscopy procedures in hospitals in the Egypt and the findings well be compared with published guidelines on good practice and clinical consensus

Eligibility Criteria:
Inclusion Criteria:

* Bronchoscopy Units personnel

Exclusion Criteria:

* N/A
Lactulose Supplementation in Premature Infants

A pilot study to test the safety of use of lactulose in preterm infants and to preliminary assess the hypothesis that lactulose would support the early growth of Lactobacilli in the stools of premature infants and possibly would also improve nutritional status and decrease NEC and late-onset sepsis.

Prospective, double-blind, placebo-controlled single center pilot study in 23-34 weeks gestation premature infants. Study group will receive 1% lactulose, while control group will receive 1% dextrose placebo in all their feeds (human milk or preterm formula). Clinical parameters will be followed. Stool samples will be sent for culture.

Eligibility Criteria:
Inclusion Criteria:

Premature infants were recruited based on the following criteria:

* 23-34 weeks' gestation (as determined by a combination of maternal dates, early prenatal ultrasonography and postnatal gestational age estimation based on physical and neuromuscular signs (New Ballard Score), as long as there will be gestational age agreement between the 3 methods \< 2 weeks);
* Absence of major congenital malformations; and
* Informed consent obtained from parents.

Exclusion Criteria:

* Major congenital malformations and parental refusal.
Alopecia Prevention Scalp Cooling in Chinese Breast Cancer Patients

The Orbis Paxman Hair Loss Prevention System is a new equipment introduced to Hong Kong in 2017. Although this device has been widely used in the United States, Europe and Australia, acceptability, efficacy and safety data in Chinese have not yet been available. The objective of this prospective study is to collect clinical data in Chinese patients using the Orbis Paxman Hair Loss Prevention System to prevent chemotherapy-induced alopecia.

This project seeks to demonstrate that the Orbis Paxman Hair Loss Prevention System is safe and effective in reducing chemotherapy-induced alopecia in woman with breast cancer undergoing neoadjuvant or adjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

i) New diagnosis of breast cancer stage I-III

ii) Chinese ethnicity

iii) ECOG 0-1

iii) Planning to undergo neoadjuvant or adjuvant chemotherapy with curative intent

iv) Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline and/or taxane based chemotherapy regimen,

1. Defined as one of the following regimens:

   * Adriamycin 60 mg/m2 with cyclophosphamide 600 mg/m2 for 4 cycles (AC) \> 5-Fluorouracil 500 mg/m2, Epirubicin 100mg/m2, and cyclophosphamide 500 mg/m2 for 3 cycles, followed by Docetaxel 100 mg/m2 for 3 cycles (FEC-D)
   * AC x 4 cycles, followed by Docetaxel 100 mg/m2 for 4 cycles (AC-D)
   * AC x 4 cycles, followed by Paclitaxel 175 mg/m2 for 4 cycles (AC-P)
   * Docetaxel 75 mg/m2 with cyclophosphamide 600 mg/m2 for 4-6 cycles (DC)
   * Docetaxel 75 mg/m2 with carboplatin AUC of 5-6 for 4-6 cycles (DCb)
2. Concurrent trastuzumab and/or pertuzumab at standard doses is allowed.
3. Administration of chemotherapy on a dose dense schedule with GCSF is allowed.

v) Adequate organ functions vi) Normal thyroid stimulating hormone vii) Subjects with history of diabetes must have acceptable HBA1c on study entry viii) Subjects who provide consent and are mentally competent and able to fill in study questionnaires

Exclusion Criteria:

i) Subjects with any other concurrent malignancy including hematological malignancies (i.e. leukemia or lymphoma)

ii) Subjects with cold agglutinin disease or cold urticaria

iii) Age ≥ 70 years

iv) Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and/ or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, subject may go on study at the discretion of the Principal Investigator.

v) Elevated liver enzymes or bilirubin defined as 3 times the upper limits of normal

vi) Serum Albumin \< 3.0

vii) Subjects with anemia (defined as a hemoglobin \< 10)

viii) Subjects who have lichen planus or lupus, or other dermatological conditions involving scalp

ix) Subjects who are underweight (defined as a BMI \< 18.5)

x) Subjects who have had previous chemotherapy exposure
Protein Ingestion Timing on Body Composition and Biochemical Markers in Resistance-trained Males

Protein ingestion timing is an important component for muscle accretion. We hypothesized that protein ingestion timing could affect muscular adaptations and performance in resistance-trained men.


Eligibility Criteria:
Inclusion Criteria:

* performing resistance training at least three times a week for 1 year prior to the start of the study
* not taking any steroids or any illegal agents known to increase muscle size for at least 1 year prior to the start of the study
* no known medical issues
* sleeping for at least seven to eight hours during the 24-hour day

Exclusion Criteria:

* non-willingness to continue protein ingestion or exercise protocols
* participation in exercise other than the prescribed resistance training program
* consumption of dietary supplement (other than the protein intervention) during the study period
* Missing more than one resistance training session or protein ingestion throughout the study period
Evaluation Using Computed Tomography Angiography (CTA) to Investigate and Detect Atherosclerotic Graft Disease (ELUCIDATE)

The purpose of clinical research is to look at the nature of disease and try to develop improved methods to diagnose and treat disease.The goal of this study is to evaluate the use of computed tomography (CT) scan of the heart in the diagnosis of disease in vein grafts after bypass surgery.

Patients who have bypass surgery with using vein grafts from their legs (saphenous veins) have a very high risk of developing blockages in the grafts. It has been shown in previous studies that the progression of disease in vein grafts is very quick and can result in chest pain, heart attacks or death. In the past, evaluation of the grafts was possible with heart catheterization only. The technique of CT scan is currently considered an effective way to look at vein grafts as well as the arteries around the heart to identify blockages.

Certain blood proteins have been associated with rapid progression of vein graft blockages. Our purpose is to not only to identify blockages at different stages after bypass surgery, but to investigate the causes of the rapid progression of the disease, including clinical history, risk factors and the blood proteins.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to provide informed consent.
2. Age equal to or greater than 18 years.
3. One(-/+60days), 3 (-/+60days), 5 (-/+60days), or 7 (-/+60days) years after coronary artery bypass graft surgery.

Exclusion Criteria:

1. Renal (kidney) insufficiency (creatinine greater than or equal to 1.6) or renal (kidney) failure requiring dialysis.
2. Atrial fibrillation (type of heart rhythm) or other markedly irregular rhythm.
3. Inability or refusal to provide informed consent.
4. Pregnancy or unknown pregnancy status.
5. Age less than 18 years.
6. Clinical instability as deemed by the attending physician, including cardiogenic shock, hypotension (low blood pressure-systolic blood pressure less than 90 mmHg), refractory hypertension (high blood pressure) (systolic blood pressure greater than 180 mmHg), sustained ventricular or atrial arrhythmia (types of heart rhythm) requiring intravenous medications.
7. Inability to tolerate beta-blockers, including those with chronic obstructive pulmonary disease (temporary narrowing of the tubes in the lungs) (or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block (chambers in the heart not beating in sync), second-degree atrioventricular block (chambers in the heart not beating in sync).
8. Known contrast dye allergy.
HLA Sensitization Following Major Cortical Allograft Bone Procedures

The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone.

Patients who have bone cancer often have the cancerous bone removed by surgery and replaced with a piece of bone taken from a donor (a person who donates parts of their body to be used for transplants after their death). However, sometimes this replacement bone does not heal together with the patient's bone. The reason the bone does not heal is not known but it is thought that the patient's body may react to the donor bone by producing antibodies against cells on the donor bone. The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone. You have been asked to participate in this study because you are scheduled to undergo this type of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients twelve years or older who are scheduled for massive fresh-frozen human structural bone allograft implantation at participating centers will be given the opportunity to participate in the study. All patients must have a reconstruction of the involved long bone with either an intercalary graft, an osteoarticular graft, or an allograft/endoprosthesis composite graft. The junction or union site studied will be the cortical-cortical, host allograft junction site, not the cancellous interfaces.

Exclusion Criteria:

* Patients who do not require major weight bearing cortical allograft bone grafts will be excluded. Also, women who are or could potentially become pregnant will be excluded from the study.