cyrilzakka/clinical-trials huggingface dataset:
Low Dose Total Skin Electron Beam Radiation Therapy and Mechlorethamine Hydrochloride Gel in Treating Patients With Mycosis Fungoides

This phase II trial studies how well low dose total skin electron beam radiation therapy and mechlorethamine hydrochloride gel work in treating patients with mycosis fungoides. Total skin electron beam radiation therapy uses high energy x-rays directed at the entire surface of the body to kill cancer cells and shrink tumors. Mechlorethamine hydrochloride gel may help patients in remission of disease, reduction in disease staging, and enhanced quality of life. Giving total skin electron beam radiation therapy and mechlorethamine hydrochloride gel may work better in treating patients with mycosis fungoides.

PRIMARY OBJECTIVES:

I. To assess the time to progression of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance mechlorethamine hydrochloride gel (Valchlor) regimen.

SECONDARY OBJECTIVES:

I. To assess the response rate (complete response \[CR\] and partial response \[PR\]) of patients treated with total skin electron beam therapy (TSEBT) followed by the year-long maintenance Valchlor regimen.

Eligibility Criteria:
Inclusion Criteria:

* Documentation of diagnosis as evidenced by one or more clinical features consistent with mycosis fungoides cutaneous T-cell lymphoma
* Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with requirements of the study
* Skin biopsy specimen of representative lesion obtained at screening of study and deemed diagnostic of mycosis fungoides by principal investigator
* Mycosis fungoides patients that have stage T2-4 N0-1 M0B0 disease
* Availability of subject to be observed for up to 18 months post-screening evaluation
* Life expectancy greater than 6 months

Exclusion Criteria:

* Pregnant or breast-feeding females
* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data
* Patients diagnosed with Sezary syndrome; Sezary syndrome is equivalent to mycosis fungoides that develops to stage IVA/B with B2 (high blood tumor burden) involvement, and as such requires a more aggressive treatment regimen than Valchlor or TSEBT
* Underlying medical condition including unstable cardiac disease, or other serious illness that would impair the ability of the patient to undergo treatment
* Minimum 3 weeks since prior systematic treatment or phototherapy
* Exclusion of people that do not understand the risks, such as decisionally-impaired individuals, prisoners, and vulnerable populations
Low-dose Droperidol for Prevention of Postoperative Delirium in Elderly Patients After Non-cardiac Surgery

The aim of this multicenter, prospective, randomized, double-blind and large sample study is to explore the preventive effect of low-dose droperidol on POD in elderly patients after non-cardiac surgery, providing new approach for reducing the incidence of POD and improving the prognosis and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Age≥65 years
* American Society of Anesthesiologists (ASA): I-III
* Planning to undergo elective non-cardiac surgery under general anesthesia with endotracheal intubation, including digestive, orthopedic, urologic and gynecological surgery
* Estimated operation time more than 2 hours
* Not expected to be admitted to ICU postoperatively
* Proficient in Chinese
* Informed consent

Exclusion Criteria:

* Morbid obesity with BMI \>35 kg/m2;
* History of psychological and neurological diseases, such as depression, schizophrenia, epilepsy, severe central nervous system depression, Parkinson's disease, Alzheimer's disease, myasthenia gravis, basal ganglia disease, etc;
* Corrected QT (QTc) of electrocardiogram\> 500ms;
* Preoperative liver insufficiency (Child Pugh grade C);
* End-stage renal disease requiring dialysis;
* Severe heart failure \[Metablic equivalent (METs)\<4\];
* Allergic to droperidol;
* Inability to communicate due to coma or dementia in preoperative period;
* Preoperative delirium, assessed by 3D-CAM;
* More than three standard alcoholic drinks per day (≈10 g alcohol , equivalent to 50 g of strong Chinese spirits);
* Participating in conflicting clinical trials;
* Expected to have an additional operation within 7 days after the index operation.
All-Case Surveillance of Ofev in Patients With IPF in Japan

This is a non-interventional study based on new data collection to gather real-world information (i.e., data under routine medical practice) on safety and effectiveness of the Ofev® Capsules treatment.

The study will consist of a baseline visit and follow-up visits at Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 for patients who have newly initiated Ofev® Capsules. The patients will be followed up until discontinuation of Ofev® Capsules treatment.

As this is an observational study, no specific treatment is mandated or withheld from the patients. The choice of maintenance treatment for IPF must be according to regular medical practice and at the discretion of the physician (i.e., no randomised assignment of patient to treatment is performed).

All patients administrated Ofev® Capsules after the launch at the sites contracted with the sponsor will be registered. The Case Report Forms (CRFs) of 1000 patients will be collected. However the patient registration continues until the approval condition has been removed.

Patients participating in the subsequent follow-up will undergo regular observations. These observations should be reported after approximately Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 since the initiation of Ofev® Capsules as long as they continue to receive the treatment. Patients will not be followed any longer once they are reported to have discontinued the Ofev® Capsules treatment.


Eligibility Criteria:
Inclusion criteria:

Essentially, patients are diagnosed with IPF based upon the most recent the American Thoracic Society (ATS), the European Respiratory Society (ERS), the Japanese Respiratory Society (JRS), and the Latin American Thoracic Association (ALAT) guideline.
Modification of Goal-directed and Habitual Behavior in Addiction

This study aims to examine the modification of the hypothesized imbalance between goal-directed and habitual behavior and its neural correlates in smokers. Two interventions will be used as add-on trainings to a smoking cessation program.

In this study, the investigators aim to assess the imbalance between goal-directed and habitual behavior, its neural basis and how it can be differentially modified in treatment-seeking smokers, using two training interventions. The first intervention is cognitive remediation treatment (CRT), also known as cognitive enhancement therapy, focusing on improving inhibitory control and executive functions. The second intervention, a computer-based habit-modifying training focusing on implicit drug seeking ("implicit computer-based habit-modifying training", ICHT) uses a conditioning approach through implicit priming and contextual modulation. Indicators of the imbalance will be examined with respect to reward devaluation, cue reactivity and a pavlovian instrumental transfer (PIT) paradigm. The investigators hypothesize that both interventions change the balance between goal-directed and habitual behavior but by different mechanisms. Whereas CRT should directly increase cognitive control, in contrast, ICHT should affect the early processing and the emotional valence of smoking and smoking cues.

Eligibility Criteria:
Inclusion Criteria:

* severe tobacco use disorder (TUD) according to DSM-5
* sufficient ability to communicate with investigators and answer questions in both written and verbal format
* ability to provide fully informed consent and to use self-rating scales

Exclusion Criteria:

* severe internal, neurological, and/or psychiatric comorbidities; other Axis I mental disorders other than TUD according to ICD-10 and DSM 5 (except for mild depression, i.e. F32.0, adjustment disorder and specific phobias) in the last 12 months
* history of brain injury
* severe physical diseases
* common exclusion criteria for MRI (e.g. metal, claustrophobia)
* positive drug screening (opioids, benzodiazepines, barbiturates, cocaine, amphetamines)
* psychotropic medication within the last 14 days
* pregnancy
A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer

This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* female participants, \>=18 years of age;
* stage III, or inflammatory breast cancer;
* estrogen receptor/progesterone receptor (ER/PgR) positive or negative and human epidermal growth factor receptor 2 (HER-2) negative;
* normal left ventricular ejection fraction (LVEF).

Exclusion Criteria:

* previous chemotherapy/endocrine therapy;
* evidence of distant metastatic disease;
* other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);
* chronic daily treatment with \>325 milligram per day (mg/day) aspirin, or \>75mg/day clopidogrel.
A Open-label, Drug-Drug Interaction With Maraviroc (DDI)

This is a Phase 1, open-label, single sequence, two-way interaction study in healthy male and female subjects. For the effect of maraviroc on the pharmacokinetics (PK) of BMS-626529 (the active moiety of BMS-663068), there is no formal hypothesis to be statistically tested. The purpose of this assessment is to estimate the effect of maraviroc on the PK of BMS-626529 when coadministered in healthy subjects. For the effect of BMS-663068 on the PK of maraviroc, the hypothesis to be statistically tested is that BMS-663068 will not have a clinically significant effect on the PK of maraviroc when coadministered in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive with a body mass index of 18.0 to 32.0 kg/m2, inclusive
* Women of childbearing potential must agree to follow instructions for methods of contraception for a total of 34 days post-treatment completion

Exclusion Criteria:

* Any condition possibly affecting drug absorption
* Pre-existing liver dysfunction
* Any significant acute or chronic medical illness
* Orthostatic intolerance
* Other protocol specified exclusion criteria could apply
Retreatment With CTL019/CTL119

This research study is designed to evaluate the effects of retreatment with CTL019/CTL119 in patients with late relapse of B-cell lymphomas.

This is a single arm open label trial that will assess the safety and efficacy of retreatment with CTL019/CTL119 chimeric antigen receptor (CAR) modified T cells in patients who have late relapse of diffuse large B-cell or follicular lymphoma after achieving complete remission from prior CTL019/CTL119 treatment. Patients eligible for this protocol will have been treated initially with CTL019/CTL119 under UPCC13413/NCT02030834, have experienced a durable complete response (defined as ≥ 6 months duration), and have a residual manufactured CTL019/CTL119 product available. This protocol will serve subjects with no available potentially curative treatment options (such as autologous or allogeneic stem cell transplantation) who have a limited prognosis (months to \< 2 year expected survival) with available therapies.

Eligibility Criteria:
Inclusion Criteria:

1. Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+
2. Previously treated on UPCC13413/ NCT02030834 with CTL019/CTL119, with historical manufactured product available at Penn for reinfusion
3. Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days)
4. No available curative treatment options (such as autologous or allogeneic HSCT) with limited prognosis (several months to \< 2 year survival) with currently available therapies.
5. Age ≥18 years
6. Creatinine \< 1.6 mg/dL
7. ALT/AST \< 3x upper limit of normal
8. Bilirubin \< 2.0 mg/dL, unless subject has Gilbert's Syndrome (≤3.0 mg/dL)
9. Measurable or assessable disease according to the "Revised Response Criteria for Malignant Lymphoma" (Cheson et al., J. Clin. Onc., 2007)88. Patients in complete remission with no evidence of disease are not eligible.
10. Performance status (ECOG) 0 or 1.
11. Left Ventricle Ejection Fraction (LVEF) \> 40% confirmed by ECHO/MUGA
12. Agree to contraceptive requirements outlined in Section 4.3.
13. Provide written informed consent.

Exclusion Criteria:

1. Uncontrolled active infection.
2. Active hepatitis B or hepatitis C infection.
3. Any uncontrolled active medical disorder that would preclude participation as outlined.
4. Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1).
5. HIV infection.
6. Patients with active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \>4 weeks before enrollment
7. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.
Exploration of Risk Factors for Postoperative Cerebral Infarction in Lung Cancer Patients: a Retrospective Single-centre Study

Lung cancer remains the world's leading cancer in terms of morbidity and mortality, with more than 20 million new cases and 9.7 million deaths annually. Despite improvements in surgical techniques and medical care, the number of elderly people undergoing surgery is gradually increasing, so there are an increasing number of complications following lung resection. Postoperative cerebral infarction is a relatively rare but devastating complication that places a heavy burden on patients and families. The incidence of postoperative cerebral infarction in patients after thoracic surgery has been reported to be 0.6-1.1%. There is a risk of postoperative cerebral infarction after lung cancer surgery, and the results of a few studies have shown that postoperative cerebral infarction is related to old age, male, hypertension, hyperlipidemia, and lobectomy factors, but the pathogenesis of the occurrence of cerebral infarction has not been clearly proved for the time being, and so these risk factors cannot be taken as the direct cause of cerebral infarction. Therefore, we need to further explore the factors leading to cerebral infarction after lung cancer surgery. If we can further prove that some of the risk factors are related to the causes of cerebral infarction after lung cancer surgery, we can make corresponding strategies in the perioperative period to improve the safety of surgery and reduce the incidence of cerebral infarction in the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

Postoperative cerebral infarction

Exclusion Criteria:

No postoperative infarction
A Study to Investigate the Bioequivalence Test of DA-1229_01(A) at Fed State

A study demonstrates the bioequivalence of DA-1229_01(A) at Fed State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 19 years of age at the time of health examination
* Female patients who were confirmed to be not pregnant at health examination
* Patients without a history of mental illness in the past 5 years

Exclusion Criteria:

* Patients who have taken medications which could affect the results of the clinical trial in the past 10 days of participating in the clinical trial
* Patients with a congestive heart failure which requires medicinal treatment
* Patients who have made a whole blood donation in the past 2 months or an apheresis donation in the past 2 weeks of participating in the clinical trial
* Female patients who are lactating
Natural History Study of Homocystinuria Caused by Cystathionine Beta-Synthase Deficiency (ACAPPELLA)

The purpose of the study is to characterize the clinical course of homocystinuria in pediatric and adult patients aged 1 to 65 years under current clinical management practices


Eligibility Criteria:
Inclusion Criteria:

* Patients who are clinically diagnosed with homocystinuria
* Male/female patients aged 1 to 65 years
* Patients who consented and/or assented
* Patients who are willing and able to comply with all study-related procedures.

Exclusion Criteria:

* Medically significant postnatal complications or congenital anomalies that are not associated with homocystinuria
* Received any experimental therapy for homocystinuria during the 6 months prior to enrollment or expected to receive any such therapy during duration of the study
Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control

Primary objective:

* To observe the efficacy of the forced titration to reach good glycemic control in Lantus treated patients

Secondary objectives:

* To assess the forced titration on physician and patient satisfaction
* To evaluate the impact of training tools by means of patient profile


Eligibility Criteria:
Inclusion Criteria:

* T2 insulin naïve patients
* Patients whom their physician is considering initiation of Lantus treatment
* Poor glycemic control 7,5 %10 %
* T2 treatment with OADs more than 3 months
* BMI\<40 kg/m2

Exclusion Criteria:

* Impaired renal function (Cr\>2mg/dl or current renal dialysis)
* Acute or chronic metabolic acidosis
* Active liver disease or serum ALT or AST \>2,5 than normal
* History of hypoglycemia unawareness
* Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months after study entry
* Pregnancy, breast feeding

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Compare of Surgical Condition and Complications With Moderate and Deep NM Block

This study is designed to evaluate the surgeon's satisfaction with either deep or moderate neuromuscular blockade during laparoscopic gastrectomy surgery and observe the recovery profiles in the recovery room and the ward.The explorative objective of this study is to evaluate the safety profiles of deep and moderate neuromuscular blockades via observation of postoperative complications.

Neuromuscular blocking agents (NMBAs) are frequently using during anesthesia to facilitate tracheal intubation and to improve surgical conditions. In an adequately anesthetized and monitored patient, the presence of one or two responses in the train-of-four (TOF) pattern normally indicates sufficient relaxation for most surgical procedures in general practices. It has been called moderate neuromuscular blockade (mNMB) condition. Nowadays, laparoscopic surgeries have expanded impressively into various areas of surgeries, both in scope and volume. If any hypothetical advantages of deep neuromuscular blockade (dNMB) during laparoscopic surgery turned out to be realized in practice with sufficient supporting evidence, it would become an important anesthetic option for better patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* All adult (≥ 20 years of age) patients scheduled for an elective laparoscopic gastrectomy who have signed the written informed consent.

Exclusion Criteria:

* Known allergy to rocuronuim, cisatracurium or sugammadex
* Significant liver or kidney dysfunction
* Any neuromuscular disease
* Pregnant or breast feeding
* Indication for rapid sequence induction
* Inability to give informed consent
* Patients taking any medication with potential interference with neuromuscular transmission
ONO-5920/YM529 Confirmatory Study in Involutional Osteoporosis Patients

This is a multi-center double-blind parallel-group study in involutional osteoporosis patients to compare the efficacy and safety of monthly oral intermittent formulation ONO-5920/YM529 with its daily formulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose bone mineral density is \<70% of Young Adult Mean (YAM), or \<80% of YAM who have fragile fracture history
* Patients can walk on his/her own
* Written informed consent has been obtained from the patient.

Exclusion Criteria:

* Sequential osteoporosis patients or patients with other disorders showing low bone mass
* Patients with the findings that influence measurement of lumbar vertebral bone mineral density by the DXA method
* Patients who are unable to keep raising or standing for ≥30 min
* Patients with peptic ulcer
* Patients who have experienced anamnesis or gastrectomy (total extraction)
Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

To assess the potential efficacy (in terms of objective response) of single agent copanlisib in patients with relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) and assess the relationship between efficacy and a potentially predictive biomarker


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Diffuse large B-cell lymphoma (DLBCL) (de novo or DLBCL transformed from follicular lymphoma on the basis of a tissue biopsy).
* Received at least one prior therapy for aggressive Non-Hodgkin's Lymphoma (NHL) (DLBCL).
* Received CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) + rituximab or equivalent regimen.
* Patients must have measurable disease.
* Not eligible or not willing to receive the high-dose (myeloablative) chemotherapy (HDC) and stem cell transplant (SCT).
* A fresh tumor biopsy collected during screening and /or archival tumor tissue collected after the last relapse/disease progression.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2.
* Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (LLN) for the Institution. (as per local standard of care) as measured by echocardiogram (ECHO) or Multiple gated acquisition (MUGA) scan.
* Adequate bone marrow, liver and renal function.

Exclusion Criteria:

* Any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only.
* Active CTCAE (Common Terminology Criteria for Adverse Events) Grade 3/4 infection.
* Current central nervous system (CNS) involvement by lymphoma.
* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction within the past 6 months before start of study treatment.
* Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).
* Type I or II diabetes mellitus with HbA1c \> 8.5% at Screening.
* New York Heart Association (NYHA) class III or IV heart disease.
* History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator).
* Patients who previously received therapy with copanlisib or other PI3K inhibitors are not eligible for enrollment.