cyrilzakka/clinical-trials huggingface dataset:
Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma

This is a phase 2, open label study to assess umbralisib in combination with ublituximab in participants with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).

The study will assess the safety and efficacy of umbralisib in combination with ublituximab in participants with treatment naïve FL and SLL. Ublituximab will be administered through Cycle 12, while umbralisib will be administered through Cycle 24. After this time, participants will be followed for progression free survival (PFS).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of FL or SLL.
* Measurable disease that requires treatment
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Exclusion Criteria:

* Currently or previously received treatment for their lymphoma
* Received wide field radiotherapy within 28 days or limited field radiation within 14 days of Cycle 1 Day 1
* Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection
Changes of the Hemodynamic Profiles on Bio Reactance Technique During TURP in Elderly Patients

The purpose of this study is to evaluate the change of the hemodynamic profiles on bio reactance technique during TURP in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

1) Twenty (ASA status I \~ III) patients, ages 65 to 80 yr old, who were scheduled for transurethral resection of the prostate under spinal anesthesia

Exclusion Criteria:

1. if there were contraindications for spinal anesthesia including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.
2. history of coronary artery bypass surgery
3. history of dementia
4. have a difficulty in understanding informed consent or refuse to sign the informed consent
5. patients height under 150 cm
Effectiveness of an Educational Intervention Aimed at Increasing the Emotional Competencies of Patients Under Surveillance After Antineoplastic Treatment of Oesogastric or Bronchopulmonary Cancer

Emotional skills are the ability to use emotions cleverly in daily life. Good emotional skills are associated with better mental and physical health in healthy and clinical populations. However, to our knowledge, cancer patients have never benefited from an intervention aiming at increasing their emotional skills. Our goal was thus to design and test such an intervention. A prospective, multi-center, randomized controlled trial (RCT) will be conducted in esogastric and lung cancer patients after antineoplastic treatments. Forty-three patients are expected in each arm. The primary outcome is the change in emotional skills assessed using a patient-reported validated questionnaire between the start and two weeks after the end of the intervention and at 2-month follow-up. The experimental arm will have to follow three individual sessions on emotional skills (i.e. identification, understanding, expression and regulation of emotions) while the control arm will have to follow three sessions of relaxation. In each arm, the first session can be held face to face or over the phone and the last two sessions will be held over the phone. Patients have exercises to practice in between sessions.It is hypothesised that the experimental group will experience a greater increase in emotional skills than the control group.


Eligibility Criteria:
Inclusion Criteria:

* Patient under surveillance after curative or palliative antineoplastic treatment (surgery and/or chemoradiotherapy and/or radiotherapy alone and/or chemotherapy alone) of esogastric or bronchopulmonary cancer,
* Patients with a life expectancy estimated by their physician involved in the research to be greater than or equal to six months,
* Patient with a ≥ 4 score on the Distress Scale (scale from 0 to 10),
* Affiliation to a social security scheme,
* Mastery of the French language,
* Signing of informed consent to participate in this research.

Exclusion Criteria:

* Cognitive disorders or unstabilized psychiatric disorders that may impair the ability of reasoning and thinking necessary to complete the questionnaires and attend workshops
* Difficulty or deficiency that prevent the patient from a good understanding of the imperatives of the research
* Any situation likely to significantly affect emotional competence during the study according to the investigator's judgment (in particular, ongoing psychotherapeutic follow-up))
* Patients under judicial protection (guardianship or curators).
Spinal Motor Evoked Potentials in Brain Surgery

During neurosurgical resection of brain tumors within brain areas for motor control, it is important to monitor motor function. For this muscle motor evoked potentials are used. Those are elicited by transcranial and direct cortical stimulation. Motor responses are recorded from muscles. In neurosurgical procedures for spinal cord tumors, the same methods are used, but additionally motor activity is recorded from the spinal cord. This is called spinal motor evoked potentials. It is known that the relation between spinal and muscle motor evoked potentials helps to extent the resection of spinal cord tumors. This study implements the spinal motor evoked potential into brain tumor surgery and analyses the relationship between spinal and muscle motor evoked potentials. With this, detection of injury to the brain area for motor control might be discovered earlier and thus tumor resection can be performed safely.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* tumor location adjacent to the motor cortex and corticospinal tract

Exclusion Criteria:

* minor
* neurological degenerative diseases
* neurological immunological diseases
* drug abuse
* implanted medical devices such as cardiac pacemaker
* spine deformation
Investigation of the Efficacy of Transcranial Magnetic Stimulation in Patients Developing Complex Regional Pain Syndrome Type 1 in the Upper Extremity During the Subacute-Chronic Period After Ischemic Stroke

The aim of our study is to investigate transcranial magnetic stimulation (TMS) as a treatment option in Complex Regional Pain Syndrome, disseminate it to a broader patient population, and simultaneously demonstrate its applicability in the treatment of complex regional pain syndrome using a novel frequency matching.

After ischemic stroke in the subacute to chronic period, 45 patients developing complex regional pain syndrome in the upper extremity will be divided into three groups: those receiving combined rTMS with conventional rehabilitation (occupational therapy and transcutaneous electrical stimulation for pain), those receiving sham rTMS with conventional rehabilitation, and those undergoing only conventional rehabilitation. The TMS group is planned to include 15 patients, the sham group 15 patients, and the group included in the conventional rehabilitation program only will also consist of 15 patients.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Complex Regional Pain Syndrome Diagnosis of ischemic stroke

Exclusion Criteria:

Epilepsy Pregnancy Cardiac Pacemaker, Brain pacemaker, Cochlear Implants
Study of Anti-telomerase T CD4 Immunity in Metastatic Lung Cancer

Increasing evidence suggests that immune responses might be a determining factor in lung cancer tumor progression.

The impressive clinical responses obtained with immune checkpoint inhibitors (anti-PD-1/PDL-1, anti-CTLA-4) indicate that the presence of preexisting antitumor immune response is required for their efficacy and highlight the critical role of antitumor T cell immunity. Recent progress on the fields of tumor immunology underlines the critical role of CD4 helper 1 T lymphocyte (TH1) in the control of innate and adaptive anticancer immunity. Therefore, monitoring tumor specific TH1 response could be relevant in cancer patients.

In order to monitor tumor-specific CD4 Th1 responses in most cancer patients, the investigators group have previously described novel promiscuous peptides (referred as UCP:Universal Cancer Peptides) derived from human telomerase (TERT), a prototype of shared tumor antigen.

By using UCP-based immuno-assay, pre-existing UCP-specific Th1 responses have been detected in the blood of lung cancer patients (Telocap01). The frequency and magnitude of this response were inversely correlate to the disease stage. Furthermore, UCP-specific responses were significantly found in patients with low PD1+ and TIM3+ T cells.

Then in TeloCap02 study, UCP specific Th1 immune responses will be evaluated in lung cancer before and after treatment (chemotherapy, immunotherapy).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC (Non Small Cell Lung Cancer) or SCLC (small cell lung cancer)
* stade IIIb or metastatic
* Patient candidate to a first-line therapy
* Performance status 0, 1 or 2 on the ECOG scale
* Written informed consent

Exclusion Criteria:

* History of adjuvant chemotherapy for lung cancer treatment
* Patients under chronic treatment with systemic corticoids or other immunosuppressive drugs (prednisone or prednisolone ≤ 10 mg/day is allowed)
* Prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 5 years
* Active autoimmune diseases, HIV, hepatitis C or B virus
* Patients with any medical or psychiatric condition or disease,
* Patients under guardianship, curatorship or under the protection of justice.
Neuropsychological and Biopsychosocial Evolution During Pediatric Transplantation: Pre/Post-stages and at 6 Months

This pioneering prospective observational study aims to examine biopsychosocial and neuropsychological functioning, care needs and predictors of therapeutic adherence in children/adolescents in pre/post-surgical transplant (solid organ or allogeneic haematopoietic stem cell) phases. Hypothesis: H1. Differences in biopsychosocial and neuropsychological functioning and adherence will be observed between transplant types; H2. Executive functioning will mediate the relationship between anxiety, sleep disturbance and pain intensity/interference and adherence; H3. There will be a significant improvement in different neuropsychological indicators 6 months post-transplantation. Sample: patients (8-18 years) extracted by non-probabilistic sampling, estimating a sample size of 60 patients (30 for each type of transplant, organ and haematopoietic) from Hospital Universitario La Paz (Madrid). Individual pre/post-surgical assessments will be carried out (after 2 and 4 weeks), as well as at 6 months post-transplant, both in person (neurocognitive) and through the secure platform REDCap (completed by patients and their legal guardians). Finally, focus groups will be conducted among patients, their relatives and medical-surgical professionals to identify barriers to therapeutic adherence and unmet care needs during the pre-, peri- and post-surgical process.


Eligibility Criteria:
Inclusion Criteria:

* Spanish as mother tongue or a very high level of Spanish in order to understand their participation in the study, as well as to be able to complete the measurement instruments.

Exclusion Criteria:

* Diagnosis of intellectual disability, autism spectrum disorder or acquired brain damage.
* Diagnosis of uncontrolled/stabilised comorbid disease, independent of the disease motivating the transplantation process.
Patient Experience of Consent for Cancer Surgery in Light of Recent Changes to UK Law- a Questionnaire Study

Since the 2015 Montgomery vs Lanarkshire Health Board ruling, the consent process in the UK has had to change. In practice, this means that doctors must ask themselves whether the patient knows about the material risks of the treatment being proposed, alternatives to the treatment, and whether reasonable care has been taken to ensure the patient actually knows this. This study aims to determine patients' perspectives of consent for major cancer surgery in light of the Lanarkshire ruling.

A patient satisfaction survey was administered to patients who had undergone urological, gynaecological, colorectal, and plastic surgical procedures at a specialised cancer centre where changes to consent processes in light of the Lanarkshire ruling had been implemented.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have been admitted and undergone surgery within a 6 week period between April - June 2018.

Exclusion Criteria:

* Any patient who could not complete the survey questionnaire i.e. English was not their first language or to unwell to complete.
Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis

The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.

Hospitalized patients who require DVT prophylaxis and who are not good candidates for heparin-based anti-coagulation were eligible.

Eligibility Criteria:
Inclusion Criteria:

1. Provide written informed consent before initiation of any study related procedures.
2. Be at least 18 years of age.
3. Patients requiring anticoagulation for the prophylaxis of thrombosis.
4. In the opinion of the Investigator, an alternative to heparin-based anticoagulant therapies is desirable.

Exclusion Criteria:

1. Confirmed pregnancy (if woman of child-bearing potential) (urine or serum pregnancy test).
2. Intracranial neoplasm, arteriovenous malformation or aneurysm.
3. Severe renal insufficiency (chronic or acute) with a GFR of \< or equal to 30 mL/min as determined by measured or estimated creatinine clearance using Cockroft-Gault method or by estimated GFR using the MDRD formula.
4. Known allergy to desirudin or hirudin-derived drugs, or known sensitivity to any component of the product
5. Participation in other clinical research studies involving the evaluation of other investigational or FDA-approved drugs or devices within 30 days of enrollment (participation in observational studies of FDA-approved products is acceptable).
6. Refusal to undergo blood transfusion should it become necessary
7. Active bleeding or irreversible coagulation abnormality.
8. Uncontrolled hypertension defined as a blood pressure \> or equal to 180/110 mmHg.
9. Patients requiring anticoagulation for left-ventricular assist device, intra-aortic balloon pump, veno-venous ultra filtration or ECMO.
10. Any other disease or condition which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial.
Girls in Transition Study: Helping Girls Enter the Teenage Years

This is a pilot study of the Girls in Transition (GT) program, an intervention designed to promote resilience and reduce gender-related risk factors for depression. The goal of the study is to gather preliminary data on the effects of the GT program.

Gender differences in rates of depression emerge during adolescence. Although rates of depression increase for both boys and girls during adolescence, the increase is more dramatic for girls. By late adolescence, girls are twice as likely as boys to develop depression. Because the transition to adolescence has been identified as a period of increased risk for girls, preventive interventions targeting early adolescent girls may promote resilience and prevent depression. The Girls in Transition (GT) program is a group intervention for 6th through 8th grade girls and is designed to address risk factors that are specific to girls. This study evaluates the effectiveness of the GT intervention in promoting coping strategies, preventing symptoms of depression and anxiety, and providing benefits in other outcomes related to depression, such as self-image.

Adolescents in this study will be assigned to one of two conditions: a group that will participate in the GT program in Spring 2006 (GT #1), or a waitlist control group that will participate in the GT program approximately two years later (GT #2). Students who participate in the program will attend eleven 90-minute after-school sessions led by the investigators. In the GT program, students learn cognitive-behavioral skills (such as strategies to cope with emotions and negative thinking) and problem-solving skills (such as assertiveness), and they discuss societal messages about women's appearance and roles. Adolescent participants will complete questionnaires about coping strategies, self-image, and feelings of hopelessness, depression and anxiety at five points during the study: at the beginning of the study (baseline) and at follow-ups approximately 6, 12, 16, and 24 months after baseline. In addition, students will complete an interview at baseline and then again 12 months later about experiences in which they have coped with stressful situations. Parents will complete a questionnaire about their child's life events at three assessment points (baseline and at follow-ups approximately 12 and 24 months after baseline).

Eligibility Criteria:
Inclusion Criteria:

* Female
* Student in grades 6 through 8
* Student in participating school

Exclusion Criteria:

* Male
CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects

CaP Cement is Equivalent to Iliac Bone Graft in Filling of Large Metaphyseal Defects

Background: A bone graft from the iliac crest has long been the gold standard for filling voids in opening wedge osteotomies. CaP bone cement has been considered the possible alternative to bone graft.

Methods: 20 adult patients with distal radius malunions and dorsal deformities were randomised intra-operatively to bone graft (10) or CaP bone cement (10). Dorsal titanium locking plates were used and the wrist was stabilised in a cast for 8 weeks. Follow-ups for 24 months included VAS on wrist and iliac crest, grip strength, ROM bilaterally, Quick-DASH and Gartland \& Werley's functional scoring system. X-rays and CT scans were taken at 8 wks, 3-6-12-24 mths.

Eligibility Criteria:
Inclusion Criteria:

* distal radius malunion with dorsal deformity, disability and pain.

Exclusion Criteria:

* age under 18 years, bad health, inflammatory arthritis and radio-carpal osteoarthritis.
Improvement of Medical Quality and Outcomes Through Intelligent Management and Decision System of Cerebrovascular Diseases Based on Hospital Information System

This study applied a cerebrovascular disease organizational management and decision system based on hospital information system, aiming to verify the effect of intervention and management after stroke on improving the functional outcomes of acute ischemic cerebrovascular disease through a cluster randomized controlled study.

Stroke is a major cerebrovascular disease that causing high morbidity, disability and mortality. Management of the acute phase of stroke is critical to functional outcomes. Our study aims to verify an intervention method based on hospital information management decision system for the prevention and management of post-stroke treatment in acute stroke patients and improve long-term functional prognosis.

This study was a multicenter, open-label, parallel, cohort randomized controlled study, recruiting acute ischemic stroke patients with a post-onset National Institutes of Health Stroke Scale (NIHSS) score of ≥ 2 (limb score ≥1) within 7 days from onset of symptoms. This study will recruit a total of 3540 patients in 30 secondary hospitals. Patients in the intervention group will receive the organizational management based clinical decision support system recommended by the guidelines and conduct intervention management for patients with acute ischemic stroke. All patients in control group were treated with conventional diagnosis and treatment. The primary endpoint event was unfavorable functional outcome 3 months after onset. Secondary outcomes were in-hospital complications (including pneumonia, deep vein thrombosis), unfavorable functional outcomes at 6 and 12 months of onset (Modified Rankin Score (mRS) Score 2-5), recurrent stroke at 3, 6, and 12 months, new vascular events (including ischemic stroke, hemorrhagic stroke, myocardial infarction or vascular death) and all-cause death.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18.
* Diagnosed with ischemic stroke confirmed by magnetic resonance imaging (MRI) or brain computed tomography (CT).
* Within 7 days from onset of symptoms.
* With a NIHSS score of ≥2 at admission (limb score ≥1).
* With a prestroke mRS score of 0-1.
* Admission from the emergency department or outpatient service.
* Voluntary informed consent.

Exclusion Criteria:

* Diagnosis of other cerebrovascular diseases (cerebral hemorrhage, subarachnoid hemorrhage, cerebral venous sinus thrombosis, etc.).
* Diagnosis of non-cerebrovascular disease (central nervous system infection, epilepsy, metabolic encephalopathy, etc.).
* Ischemic stroke with negative diffusion weighted imaging (DWI).
* Being tested for interventions such as drugs or instruments.
* Pregnancy or 6 weeks postpartum.
* With a life expectancy of less than 3 months or who were unable to complete the study follow-up for other reasons.