cyrilzakka/clinical-trials huggingface dataset:
HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy

The study is planned to compare the outcome of aggressive NHL patients in partial remission after four courses of front-line therapy, randomly assigned to receive either additional four courses of the same regimen or a modified HDS program.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, untreated patients with histologically documented aggressive lymphoma;
* Age between 18 and 65 years;
* Clinical stage at diagnosis: I A bulky - IV B;
* Reduction of tumoral masses, after four courses of induction therapy, between 50 and 75%;
* Serum negativity for HIV, HbsAg and HCV;
* ECOG performance status 0 through 4;
* Adequate bone marrow function;
* Adequate renal and hepatic functions;
* Left ventricular ejection fraction (LVEF) \> 50%;
* No previous malignant disease;
* No previous chemo-radiotherapy;
* No cerebral or CNS involvement, assessed by clinical history, physical examination and CSF examination through lumbar puncture;
* Written informed consent given at time of randomization.

Exclusion Criteria:

* Clinical stage I no bulky, or CS IIA-B with less than three sites of disease involved;
* Patients with CR, unconfirmed complete remission (uCR), very good PR (\>75%) and clinical response less than 50%, as defined by Cheson et al., following four courses of induction therapy;
* Tumor involvement of CNS (except patients with peridural masses without liquor involvement , who can be enrolled in this study);
* Indolent lymphoma transformed in more aggressive histologic type, even if never previously treated;
* Aggressive non-Hodgkin's lymphoma in pre-transplanted patient;
* Clinically significant secondary cardiovascular disease e.g. uncontrolled hypertension, (resting diastolic blood pressure \> 115 mmHg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV;
* Left ventricular ejection fraction (LVEF) \< 50%;
* Evidence of any severe active acute or chronic infection;
* Concurrent malignancy of history of other malignancy, except basal cell carcinoma of the skin (BCC) and in situ cervical carcinoma (CIN);
* myelodisplastic syndrome;
* HbsAg, HIV-positive, or HCV-RNA-positive patients;
* Patient with psychiatric, or any disorder that compromises ability to give truly informed consent for participation in this study;
* Pregnant woman; potential child-bearing women can be enrolled if adequate contraceptive precautions are used before entering this trial and for the duration of the trial;
* Concerns for patient's compliance with the protocol procedures.
The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair

The purpose of this study is to determine whether Transversus abdominis plane block is superior to placebo or superior to local infiltration in analgesic efficacy after groin hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old
* groin hernia repair
* written consent
* ASA 1-3
* BMI 18-35

Exclusion Criteria:

* unable to communicate in Danish
* relevant drug allergy
* pain medication in the last 24 hours
* pregnancy
* alcohol or/and drug abuse
* daily opioid intake
* infection at injection site
Sleep as a Model to Understand and Manipulate Cortical Activity in Order to Promote Functional Recovery After Stroke

Brain functions are supported by multiple cell types, including neuronal and non-neuronal cells that are connected into complex networks. When the connectivity between those cells is altered or disrupted, the functioning of the brain is impaired. In stroke, the interruption of blood supply to the neural circuits results in connectivity damage and permanent disabilities. Experimental evidence suggests that some types of brain state, including sleep, can protect brain tissue from stroke and "repair" the damaged circuits. This project will investigate the neuronal mechanism underlying the protective effect of sleep on brain connectivity and network activity. To this end, the investigators will use a collection of state-of-the-art technologies including high-density electroencephalography (hd-EEG), transcranial magnetic stimulation (TMS) and transcranial alternating current stimulation (tACS). Perspectives include a better understanding of the causes and consequences of the perturbed electrical activity of the brain during sleep in stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* Age between 18 and 80 years
* First-ever right-sided stroke
* Normal or corrected to normal vision
* Demonstration of left hemispatial neglect (after a right-hemispheric brain lesion) found in a comprehensive neuropsychological test battery and clinical assessment
* At least 3 weeks post-stroke

Exclusion Criteria:

* Concomitant neurodegenerative diseases
* Psychiatric diseases
* Decompressive craniectomy
* History of documented sleep disorders in the medical record (e.g. insomnia, hypersomnia, rem-sleep behaviour disorder)
* Epileptic seizures
* Implanted medical devices (e.g.: pacemakers, cochlear implants, implanted neurostimulators)
* Presence of metal in the region of the head (excluding fixed dental implants such as tooth fillings or fixed dental braces)
* Medication with drugs possibly lowering the seizure threshold
* Alcohol or drug abuse
* Inability to follow the procedures of the study
* For female patients: in order to participate in the study, female patients in reproductive age need to take a pregnancy test (a standard urine pregnancy test will be provided).
Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)

The primary objective of this study is to assess objective response rate (ORR) in patients with relapsed or refractory MCL who failed ibrutinib treatment or were unable to tolerate ibrutinib.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed MCL
* Patients who have previously received treatment with ibrutinib (modified by amendment 1), including:

  * Completion of at least 1 cycle of treatment with ibrutinib and confirmed evidence of disease progression or refractoriness to treatment or
  * Discontinuation of ibrutinib treatment at an earlier time due to toxicity
* Measurable disease according to the Lugano Classification
* At least 28 days or 5 half-lives, whichever is shorter, from the completion of anti-cancer treatment (including, but not limited to, immunotherapy, chemotherapy, targeted therapy and biologic therapy) to the start of study treatment, excluding ibrutinib where the window may be less and at minimum 3 days (modified by amendment 1)
* Availability of fresh tumor tissue at screening
* Male or female patients ≥ 18 years old
* ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2
* Left ventricular ejection fraction (LVEF) by echocardiogram or multiple gated acquisition (MUGA) scan ≥ the lower limit of normal (LLN) for the Institution
* 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
* Current central nervous system (CNS) involvement by lymphoma
* New York Heart Association (NYHA) class III or IV heart disease
* Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). Myocardial infarction less than 6 months before start of study treatment
* Uncontrolled arterial hypertension despite optimal medical management (per investigator's assessment) (modified by amendment 1)
* Type I or II diabetes mellitus with HbA1c \> 8.5% at screening (modified by amendment 1)
* Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 3 months before start of study treatment. However, if a patient has recovered to ECOG performance status of ≤ 2 he/she may be enrolled provided that other eligibility criteria are met
* Ongoing or active infection of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3
* Known history of human immunodeficiency virus (HIV) infection
* Acute or chronic hepatitis B (HBV) or hepatitis C (HCV) infection requiring concomitant treatment prohibited by this protocol (i.e.immunosuppressive therapy)
* History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator)
* Prior treatment with PI3K inhibitor(s)
* Cytomegalovirus (CMV) PCR positive at baseline
Evaluating the Impact of a New Complement to Physiotherapy Intervention for Positional Torticollis in Infants

Children with a torticollis are usually referred for physiotherapy where they are evaluated, and given exercises as well as education to treat the condition. This study is being done in order to compare 2 methods of sharing information with parents of children with torticollis.

160 children of less than 6 months of age will be recruited for the study and divided in 2 groups. Children of both groups will receive the same physiotherapy evaluation and exercises but parents will receive information handouts with one of two different types of illustrations and written instructions for home exercises.

Eligibility Criteria:
Inclusion Criteria:

* Aged newborn to 6 months at initial visit in physiotherapy,
* A diagnosis of PT made by a physician,
* At least 37 weeks of gestational age at delivery

Exclusion Criteria:

* Congenital muscular torticollis with fibrosis (confirmed diagnosis): because this is a rare condition that has a different rate of recovery,
* Presence of craniosynostosis (confirmed diagnosis made by a neurosurgeon),
* APGAR score of less than 7 at 5 minutes,
* Prescription of a Tubular Orthosis for Torticollis (TOT) collar or Botox intervention for the torticollis,
* Confirmed diagnosis of syndrome or neurological condition.
A Feasibility Study to Improve Colorectal Cancer Screening Among Racially Diverse Zip Codes in a Persistent Poverty County Using Navigation and Machine Learning Predictive Algorithms

The overarching goals of the "PCSNaP" Research Study is to support the Abramson Cancer Center (ACC) of the University of Pennsylvania in carrying out its mission to increase colorectal cancer (CRC) screening completion among high-risk individuals living in a persistent poverty county by designing, conducting, disseminating and evaluating an electronic health record-based automated identification program to target effective, culturally-sensitive CRC screening navigation to individuals who have not completed an ordered colonoscopy or fecal immunochemical test (FIT).


Eligibility Criteria:
Inclusion Criteria:

* Patients residing in 18 zip codes in Western and Southwestern Philadelphia who have primary care providers in 4 Penn Medicine Internal Medicine practices and 3 Penn Medicine Family Medicine Practices
* Patients who have had a colonoscopy order placed in the past 6 months and have not scheduled, cancelled, or no-showed to their colonoscopy
the Treatment of Postpartum Hemorrhage Due to Placenta Previa Complete Centralis

Objective: To assess the efficacy of lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis. Method: This prospective study of 50 women with postpartum hemorrhage following removal of placenta previa complete centralis during elective cesarean section. All 50 patients will have lower uterine compression sutures (involving bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch). All patients will be followed postpartum for evaluation of uterine cavity and menstrual cycles

The investigators conduct a prospective study at Department of Obstetrics and Gynecology, Benha University Hospital, since June 2012 till July 2014, after approval of the study protocol by the Local Ethical Committee.

All patients provide written informed consent to undergo any procedure necessary, including lower uterine compression suturing procedure, as an attempt to avoid hysterectomy. They also provide written informed consent to undergo hysterectomy if all measures attempted to preserve the uterus fail.

All patients have placenta previa (50). The inclusion criteria are a gestation age of ≥ 28 weeks and antepartum hemorrhage; intraoperative postpartum hemorrhage and discovery of a placenta accreta; and an adherent placental part after piecemeal removal of the placenta, with bleeding from the placental site, posterior placenta previa and/or successful piecemeal removal of the placenta.

The first author performed all cesarean deliveries and assisted by the second author. We open the parietal peritoneum by sharp dissection and blunt expansion, high above the bladder, a bladder flap is made and the bladder is retracted. A small median transverse hysterotomy incision is done in the lower uterine segment. It is expanded on both sides using scissors, stopping shortly before the uterine arteries. Active delivery of the placenta is attempted by searching manually for a plane of cleavage between the placenta and the uterus after delivery of the fetus. The study technique comprise lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch).

Eligibility Criteria:
Inclusion Criteria:

* a gestation age of ≥ 28 weeks and antepartum hemorrhage;
* intraoperative postpartum hemorrhage and discovery of a placenta previa;
* successful removal of the placenta

Exclusion Criteria:

* shock due to massive blood loss
* failure of successful removal of the placenta
Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients with mild to moderate atopic dermatitis (AD).


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive.
2. AD diagnosed by physician / medical specialist and that has been (intermittently) present for at least 1 year
3. Able to participate and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

1. Have any current and / or recurrent clinically significant skin condition in the treatment area other than AD.
2. Any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients.
3. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
Improved Basophil Activation Test (BAT) in the Diagnostics of Drug Allergy

Current study evaluates the use of the improved Basophil Activation Test (BAT) in the diagnostics of IgE-mediated allergy to antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs).

Current study evaluates the use of the improved Basophil Activation Test (BAT) in the diagnostics of IgE-mediated allergy to antibiotics and non-steroidal anti-inflammatory drugs (NSAIDs). Among commonly used CD63/CD203c markers, newly proposed molecules, such as CD69, CD107a, CD164, CD13, CD11b and CD300a will be assayed. Results obtained together with the other clinical data will be used to calculate sensitivity and specificity of the method.

Eligibility Criteria:
Inclusion Criteria:

* suspected allergy to antibiotics or NSAIDs in the last 1 year.

Exclusion Criteria:

* autoimmune diseases;
* HIV;
* hepatitis B/C;
* other acute or chronic infectious diseases;
* malignant neoplasms;
* leukemia;
* other severe acute or chronic intercurrent diseases;
* pregnancy/lactation;
* refuse of patient to participate in the trial.
Living Renal Donor MRI Study

Accurate preoperative evaluation of a potential living renal donor's anatomy, vasculature and function is crucial to ensure optimal outcomes for both kidney donor and recipient in transplantation.

Currently abdominal ultrasound and spiral CT angiography are used to evaluate renal anatomy and vascular status, and renal scintigraphy to evaluate renal function. This imaging protocol exposes this relatively young and healthy population to a high radiation dose and potentially nephrotoxic contrast agents.

The investigators hypothesize that a single MR-based examination in the preoperative evaluation of potential kidney donor is a faster, safer, more cost effective and as accurate as the current multiple imaging work-up protocol.

An accurate preoperative assessment of the renal donor is essential to minimize the risks for the donor \& optimize the results for the recipient.

The current preoperative assessment includes Ultrasound, CT \& Renal Scintigraphy. The latter two tests subjects the patient to the risk of a high radiation dose. Moreover, the use of iodinated contrast media during CT angiography may increase the risk of renal \& systemic toxicity.

MRI can be a "one-stop shop" modality for preoperative assessment of living kidney donors. MRI also eliminates radiation exposure and the injection of potentially nephrotoxic iodinated contrast material.

The purpose of this study is to test the feasibility and evaluate the accuracy of a single MR-based examination, allowing for the comprehensive assessment of renal anatomy, function and vascular status in potential live kidney donors.

Eligibility Criteria:
Inclusion Criteria:

* Potential renal donors with no known renal disease (initial medical screening performed and scheduled for further imaging evaluation as renal donor);
* Age 18-65 years;
* No medications (birth control pills and vitamins are acceptable).

Exclusion Criteria:

* Pregnancy;
* Age \<18 years or \>65 years;
* MRI contrast allergy, general contraindications to MRI such as pacemaker, etc.
The Rhytmia System to Determine the Precise Location and Potential Mechanism of Premature Contractions

This is a purely observational project and the objectives are to record and analyze the local potentials at the site of Premature Ventricular Contraction (VPC) focus through the Rhythmia system, ti determine the short and long-term success of the procedure and compare it to the existing literature about standard procedures, to highlight the advantages of the system compared to conventional mapping and to characterize optimal pace map or activation map as achieved by the Rhythmia system.

This is a purely observational study. No special methodology choice, no comparison.

The study want to find the determination of precise location of the focus and mechanisms involved constitutes a challenge for conventional electrophysiology, even with tridimensional systems, because of the time needed for accurate delineation of the location (due to the sometimes unfrequent Ventricular Premature Beats (VPB)) and to the insufficient mapping density or inadequate signal characteristics. The Rhythmia system could allow better determination of the focus location in relation to the anatomical structures, especially with unfrequent VPB, because of the available high density mapping due to the number of closed high-resolution electrodes located on the Orion catheter. Better delineation of the true focus origin and of the mechanisms involved (automaticity vs re-entry) may be of useful help for better understanding and efficient therapy.

Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic monomorphic PVC with or without heart disease refractory to anti arrhythmic drugs
* patients with dilated cardiomyopathy and altered Left Ventricular Ejection Fraction (LVEF) suspected to be causes by frequent monomorphic VPC
* patients with malignant ventricular arrhythmias reproducibly induced by monomorphic PVC

Exclusion Criteria:

* patients with non-symptomatic VPC and without cardiomyopathy
* patients under 18 yo
* pregnant women
* patients with polymorphic PVC arising from clearly different areas
* patient protected by the french law: guardianship and Trusteeship
Audit of Hip Fractures Surgically Managed

Investigators are reviewing the the charts and medical records of participants who were operated at our institute from 2010 onward for hip fractures. Checking their outcomes (Postoperative complications, length of hospital stay and mortality) and studying their background characteristics and potential associated factors.

This retrospective study is a cohort with multiple exposures and groups. From this nested case control will be analysed as well.

Eligibility Criteria:
Inclusion Criteria:

* All patients, regardless of gender, commodities and age
* Hip fractures which were managed surgically.
* operated at our institute.

Exclusion Criteria:

* Participants with incomplete data or missing information in either the primary exposure or the outcome of interest.
* Participants with pathological fracture, open fractures, poly-trauma or revision surgeries.
A Trial of CMNa Combined With Concurrent Chemoradiotherapy for Locally Recurrent ESCC

This is a perspective, multicenter,single arm, open study to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally recurrent squamous cell esophageal carcinoma . Analyses of primary objective (ORR) will be done as defined in the protocol.

The primary end point of this study is objective response rate.The secondary end point is OS, PFS and the safety of drug. The primary hypothesis is the CMNa will improve ORR and thus improve OS, PFS. Assuming bilateral a=0.05, statistical power of 80%. The total sample size is 40 cases.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent prior to study entry
2. Patients with recurrent ESCC after radiotherapy, confirmed by imaging and pathology or cytology;
3. Capable for chemo-radiotherapy;
4. The existence of measurable lesions;
5. ECOG PS of 0 or 1
6. Possible semi-liquid diet;
7. Expected lifetime≥3 months
8. normal bone marrow reserve: ANC count ≥1500/mm3;platelet count ≥100,000/ mm3,hemoglobin≥9g/dl
9. normal hepatic function:bilirubin level ≤1.5×ULN;AST/ALT≤1.5×ULN
10. normal renal function: serum creatinine≤1.5mg/dl and calculated creatinine clearance ≥60ml/min
11. Normal cardiac function
12. Subjects tumor tissue available for the relevant biomarker detection
13. Clinical stage: No distant metastasis

Exclusion Criteria:

1. Female subject who is during pregnancy or lactation, and the subject who have fertility don't take effective contraception during study
2. Any mental illness or nervous system lesions or can't tell treatment response clearly (such as cerebrovascular accident sequelae)
3. Any serious uncontrolled disease and infection, such as severe heart, liver, kidney diseases or diabetes, can't complete the treatment plan
4. Patients who have other malignant lesions, except curable skin cancer (non-melanoma skin cancer),carcinoma in situ of cervix or serve disease cured for 5 years
5. Patients with distant metastasis.
6. Patients who have obvious esophageal ulcers or have above moderate pains in chest-back or have symptoms of esophageal perforation
7. received anti-cancer treatment of esophageal cancer before the group, including surgery, radiotherapy, chemotherapy (induction of chemotherapy before the group is greater than or equal to two cycles)
8. Not esophageal squamous carcinoma confirmed by pathology or cytology
9. History of active hepatitis
10. Unable to comprehend the study requirement or who are not likely to comply with the study requirements
11. Significant disease which, in the investigator's opinion, would exclude the patient from the study