cyrilzakka/clinical-trials huggingface dataset:
Study of Prognostic Factors in Adult Lymphoblastic Lymphoma

Retrospective observational study with systematic collection of data on filiation (age at diagnosis and sex), clinical data (IPI, ECOG, early response to chemotherapy, overall response to chemotherapy), biological (strain B or T, infiltration of the nervous system central \[CNS\], bone marrow \[MO\], lactate dehydrogenase (LDH) level at the time of diagnosis, as well as genetic patients included in the study, as well as the PETHEMA protocol used in the treatment of same patients The study will review the PETHEMA protocols from 2003 to the present

Retrospective observational study with systematic collection of data on filiation (age at diagnosis and sex), clinical data (IPI, ECOG, early response to chemotherapy, overall response to chemotherapy), biological (strain B or T, infiltration of the nervous system central \[CNS\], bone marrow \[MO\], lactate dehydrogenase (LDH) level at the time of diagnosis, as well as genetic patients included in the study, as well as the PETHEMA protocol used in the treatment of same patients The study will review the PETHEMA protocols from 2003 to the present. Analysis of the main clinical-biological variables as independent risk factors in adult patients (\> 15 years) diagnosed with ALL

Eligibility Criteria:
Inclusion Criteria:

Patients \>15 years old diagnosed with ALL and treated with the PETHEMA protocols for ALL

Exclusion Criteria:

None
Study of the Effectiveness of Supervised vs. Non-Supervised Therapeutic Exercise in Cancer Patients

AIM:To evaluate the effectiveness of a therapeutic exercise program (PET) in cancer patients in improving the quality of life and the need for supervision by health professionals during the performance of same after 6 weeks of intervention. DESIGN: Randomized and controlled clinical trial, parallel groups with active control group. With masking of randomization, patient evaluation and analysis of the data. SUBJETS OF STUDY: 58 patients diagnosed with breast and colon cancer and treated up to 2 years later, both with surgery, chemotherapy and hormonal treatments (inhibitors of aromatase, tamoxifen). INTERVENTION: both groups the treatment will be a common work-based therapeutic exercise program aerobic, strength-resistance and self-stretching, in addition to a reinforcement in recommendations usual self-care. The study includes two phases, phase of supervised work and phase of tracing. One of the groups will be supervised in the realization of PET for a period of 6weeks and the other group will do it autonomously and without supervision. The patients will be followed for 1 year, with five blind evaluations: at the beginning of the study, after 6 weeks of intervention, 3, 6 and 12 months after the start of the study.MEASUREMENTS: Principal: Quality of life assessed with the questionnaire measured with the European questionnaire Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC QLQ-30). Pre-post intervention measure, 3, 6 and 12 months. Secondary: Cancer-related fatigue evaluated with the Functional Assessment of scale Chronic Illness Therapy - Fatigue (FACIT-F). Pre-post Measurement intervention, 3, 6 and 12 months. Functional capacity measured with the Test 6 minutes walking test. Pre-post Measurement intervention, 3, 6 and 12 months. Valuation of the measured force with manual hydraulic dynamometer and 5- test repetition sit-to-stand. Pre-post intervention measure, 3, 6 and 12 months.COST: effectiveness and cost / incremental utility associated to the program wil be estimated.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-70 years.
* Oncological stage I, II or III.
* Completed adjuvant treatment between 3 months to 2 years. ECOG 1-2.
* Sign informed consent

Exclusion Criteria:

* Inability to read, understand and complete questionnaires, read and understand a brochure explanatory, understand and follow verbal orders (example; illiteracy, dementia or blindness).
* Musculoskeletal disorders that prevent the exercise of the exercise bike, elliptical, march tape.
* Important neurological disorders that involve impaired balance, coordination, ataxia.
* Sporting activity at moderate intensity exceeding 150mnts / week.
* Symptomatic anemia.
* Fecal incontinence
* Patient with a digestive ostomy.
* Decompensated heart disease,
* Uncontrolled hypertension
* Heart failure.
* Musculoskeletal pathology (except for upper limb pathology in cancer patients of mom)
* Cardio-respiratory pathology that limits physical activity
Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever

This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with Dengue haemorrhagic fever (DHF).


Eligibility Criteria:
Inclusion Criteria:

* Patients with the clinical diagnosis of Dengue Haemorrhagic Fever (DHF)
* Patients with a clinical diagnosis of DHF Grades II and III8, requiring standard replacement therapy

Exclusion Criteria:

* Patients with a clinical diagnosis of DHF Grade IV
* Known or suspected allergy to trial product or related products
* Known hypersensitivity to mouse, hamster or bovine protein
* Prior treatment with activated recombinant human factor VII
Impact of Basic Cardiopulmonary Resuscitation on the Knowledge and Attitude of Professional Football Players and Coaches

This study aims to evaluate the change in attitudes and knowledge about basic cardiopulmonary resuscitation (CPR-B) in football professionals following a training intervention and to examine its correlation with sociodemographic variables.

The study consists of two phases. The first phase involves an observational cross-sectional study to assess the level of attitude and knowledge in cardiopulmonary resuscitation. The second phase includes an educational intervention consisting of a training and practical session on CPR-B, with a pre-post intra-subject control. The questionnaire was completed by football professionals from the Spanish first division and their coaches, with N=206 in the first phase and N=70 30 days after the training intervention in the second phase.


Eligibility Criteria:
Inclusion Criteria:

* being professional football players or coaches in the Valencian Community
* accept voluntarily participating in the study. All participants gave their written consent after being informed.

Exclusion Criteria:

* Not completing the questionnaire correctly (missing data)
Mobile Microwave-based Diagnosis and Monitoring of Stroke

This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. The study assesses the diagnostic capability and safety of Strokefinder MD100.

This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. The investigator will assess and control the inclusion/exclusion criteria. If the patient is confirmed to be suitable for the trial, the patient is asked to give oral informed consent. If the answer is affirmative the microwave measurement will be performed. The procedure will take less than five minutes (the duration of the actual measurement procedure is 1.5 minutes) and will not interfere with the patient's standard of care during the hospital stay. Written informed consent is acquired by the investigator, as soon as possible after the acute phase of care is completed.

The measurement data will be evaluated for the presence of signal artifacts. The diagnostic ability of the device will be evaluated using a leave-one-out cross validation (LOOCV) method with the CT diagnosis as ground truth.

Safety will be evaluated throughout the trial, and a safety follow-up will be performed by the investigator 24 hours after the last microwave measurement. No further follow-up of patients is planned.

Eligibility Criteria:
Inclusion Criteria:

* Patient with clinical signs of stroke
* Patient should be ≥ 18 years of age
* Patient/next of kin confirms orally that the patient wants to participate in the trial (during acute phase)
* Signed Informed Consent Form (after acute phase)

Exclusion Criteria:

* Pregnant or nursing woman
* Fertile woman where pregnancy cannot be excluded
* Patient diagnosed with a condition associated with risk of poor protocol compliance
* The diagnostic procedure is deemed to interfere with the standard of care
* Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgment
* Any patient that according to the Declaration of Helsinki is deemed unsuitable for study enrolment
Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

The purpose of this study is to evaluate whether calcitriol supplementation may reduce tumor cell proliferation and influence gene expression profile of breast cancer samples from post-menopausal patients.

Women affected by breast cancer present lower 1,25(OH)2D3 or 25(OH)D3 serum levels than unaffected ones. Calcitriol supplementation may be indicated to post-menopausal women to reduce bone loss. Vitamin D has antiproliferative effects in breast cancer cell lines and breast cancer xenografts.

Post-menopausal breast cancer patients will be prescribed calcitriol supplementation, in doses indicated to prevent osteoporosis, while they are submitted to biopsy, staging exams and have their breast surgery scheduled (approximately one month). Tumor dimension and proliferation rate (as determined by Ki67 expression), 25(OH)D3 and/or 1,25(OH)2D3 serum concentration, will be evaluated before and after calcitriol supplementation. Tumor gene expression will be evaluated in samples collected before and after supplementation to analyze the differential profile.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Invasive breast carcinoma
* Clinical conditions for breast surgery
* No previous neoadjuvant treatment for breast cancer
* Agreement to take part in the study and sign the informed consent

Exclusion Criteria:

* History of hypercalcemia or nephrolithiasis
* Current use of corticosteroids, vitamin D supplementation, HRT
* Previous chemotherapy, hormonotherapy or radiotherapy
* Parathyroid disease
* Absence of clinical condition to receive supplementation
Efficacy and Safety Evaluation of Anti-CD20 Monoclonal Antibody Combined with Azathioprine and Corticosteroids in the Treatment of Pemphigus Vulgaris

A prospective cohort study was conducted, following patients for 36 weeks from January 1, 2023, to April 30, 2024. Patients meeting the diagnostic criteria were nonrandomly grouped based on screening results. The primary endpoints were time to disease control and skin healing. Secondary endpoints included complete remission rates, relapse rates, corticosteroid doses, pemphigus disease area index (PDAI), dermatology life quality index (DLQI), visual analogue scale (VAS) pain scores, CD19+ B cell percentages, desmoglein-specific antibodies, and adverse events.


Eligibility Criteria:
Inclusion Criteria:

- Patients with moderate to severe pemphigus who have poor control of previous external medications and require systemic treatment have a PDAI (Pemphigus Area and Activity Score) greater than 9 points.

Exclusion Criteria:

* Patients with serious basic diseases, with hepatitis B and three positive cases, and with a history of immunoglobulin related diseases.
Psychiatric Multi-omics and Neuroimaging Project

This study focuses on the structure and function of the brain and gene expression in peripheral blood of patients with schizophrenia, to explore the interaction and influence between the three. Patients with mental disorders who have been recruited will take their medication regularly for 1 year and participate in baseline and follow-up assessments.

The study seeks to identify possible biological markers of schizophrenia and the effects of gene-environment interactions on brain structural and functional networks. So we can help doctors and scientific researchers better understand the neuropathological basis of schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Age: 13-35 years old(Patients with healthy siblings can be extended to 14-35 years of age)
* Course of disease: \<24 months
* Priority is given to patients who have never taken medicine or duration of drug use \< 2 weeks
* No nuclear magnetic contraindications.

Exclusion Criteria:

* Family history of psychotic disorders, history of psychoactive substances abuse, alcohol dependence, or nicotine dependence
* Have a major physical disease or infectious disease
* History of coma and serious neurological disease 4.MRI contraindications.
Clinical Accuracy of the welloStationX

This study evaluates the clinical accuracy of the welloStationX, an automated non-touch self-service electronic thermometer using an infrared sensor of the surface of the forehead to screen for fever.

Traditionally, body temperature is measured using a contact thermometer placed on the forehead, in the mouth, ear, armpit or rectum. Non-contact thermometers allow a person's temperature to be taken with no contact with the person, reducing the discomfort of having to sit still for several minutes. Additionally, there is no need for disinfection between patients to occur, allowing for easier and faster use when screening large numbers of people.

This study is to evaluate the clinical accuracy of the welloStationX, a non-contact thermometer by comparing its measurements with that of the gold standard Welch Allyn SureTemp oral thermometer.

Eligibility Criteria:
Inclusion Criteria:

* Male or female.
* 5 years and up.
* Signed informed consent form.

Exclusion Criteria:

* Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the test.
* immunization within seven days of the test
Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems

The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems.

This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1), participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for contact lens care. Eligible participants will continue into the Investigational Phase (Phase 2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.

Eligibility Criteria:
Inclusion Criteria:

* Read and understand the Participant Information Sheet;
* Read, sign, and date the Informed Consent;
* Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;
* Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;
* Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;
* Best corrected visual acuity of 6/9 or better in each eye;
* Normal eyes with the exception of the need for visual correction;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
* Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
* Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;
* Systemic disease which might interfere with contact lens wear or produce dry eye side effects;
* Systemic or ocular allergies which might interfere with contact lens wear;
* Ocular disease which might interfere with contact lens wear;
* Active ocular infection;
* Use of any concomitant topical ocular medications during the study period;
* Previous ocular surgery;
* Pregnant, planning to become pregnant, or lactating at the time of enrollment;
* Participation in an investigational drug or device study within 30 days of entering this study;
* Other protocol-defined exclusion criteria may apply.
Pirfenidone in Progressive Interstitial Lung Disease Associated With Clinically Amyopathic Dermatomyositis

Interstitial lung disease (ILD) is a common complication of dermatomyositis (DM) with prevalence up to 65%, and is considered to be one of the determining factors of prognosis. Clinical amyopathic dermatomyositis (CADM), which is a special phenotype of DM, with characteristic cutaneous manifestations but no or only subclinical myopathy. Many studies, mainly from Asia, including ours, have demonstrated that these patients with CADM tend to develop a rapidly progressive ILD (RPILD) and have a poor response to conventional therapy, such as high-dose corticosteroids and immunosuppressants, leading to lethal outcome with a 6-month survival rate of less than 50%.

Pirfenidone, a new oral antifibrotic agent, has been approved for the treatment of idiopathic pulmonary fibrosis (IPF). Randomized controlled trials of pirfenidone in patients with IPF suggested that it could ameliorate pulmonary function decline and improve the progression-free survival. Its utility in connective tissue disease (CTD) related ILD has been implicated, but no evidence has yet demonstrated its efficacy. Therefore, the investigators conduct this study to evaluate the possible therapeutic effects of pirfenidone on RPILD associated with CADM.


Eligibility Criteria:
Inclusion Criteria:

* Willingness of the subject to participate in the study, proven by signing the informed consent;
* All participants fulfilled the provisional diagnosis of CADM according to the modified Sontheimer's criteria.
* The course of ILD is longer than 3 months, but shorter than 6 months, presenting as increase in level of dyspnea, and worsening of fibrosis on pulmonary HRCT with \>10% increase of HRCT score, and/or decrease in %FVC by \>10% absolute value.

Exclusion Criteria:

* Participants who are unwilling to sign the inform consent;
* The course of participants ever treated with biologics including basiliximab, or malignancy-associated CADM or overlapped with other CTD, or with alanine transaminase more than 2 times the upper normal limits;
* Pregnancy or lactation.
The Prostate Liquid Study (PLiS)

A multi-site study to evaluate the potential use of the ChEC test of seminal fluid as an additional triage test in stratifying patients for further tests.

A biomarker is a molecular substance that is an indicator of a biological condition. Cambridge Oncometrix believe that a semen biomarker may be able to predict the presence of prostate cancer. This study will allow work to be carried out on semen samples donated by men who have been identified by their GPs as having a risk of prostate cancer. Normally, GPs refer men with symptoms or a raised PSA to hospital to have an MRI scan and a biopsy.

The PLiS research team at the hospital will contact potential patients, who have been referred by their GPs, before they have an MRI or a biopsy, ask them if they are willing to take part in the study, consent them and ask them to provide a semen sample. Semen samples will be produced by the potential participants at home into a seminal fluid collection container, they will also have to complete a study questionnaire. Both the sample and the questionnaire will be returned to the central laboratory in Cambridge using the stamped addressed envelope provided.

In addition to providing a semen sample and completing a questionnaire, each participant will have two blood tests to measure male hormones. Participants then exit the trial and their usual care carries on from this point. The PLiS study will register 400 men and of those it is hoped that 300 of them will be able to provide semen.

Eligibility Criteria:
Inclusion Criteria:

1. - Men over 40 years old with suspected prostate cancer who have been referred to a secondary care
2. - Men able to produce a semen sample
3. - Men able to have a prostate mpMRI
4. - Men who have given their written informed consent

Exclusion Criteria:

1. - Previous history of prostate biopsy
2. - Contraindication to MRI
3. - Previous history of prostate surgery
4. - Treatment with 5-alpha-reductase inhibitors at time of registration or during the prior 6 months
5. - Evidence of urinary tract infection or history of acute prostatitis within the last month
6. - Androgen replacement therapy within the last 3 months
7. - Any other medical condition precluding standard diagnostic workup and collection of semen samples.
Investigation on the Incidence and Course of COVID-19 in Patients With Prior, Ongoing or de Novo ITP. Evaluation of the Impact of COVID-19 Pandemic on the Management of ITP

Multicenter retrospective and prospective observational study based on the collection of sequential anonymized data from principal Italian ITP centers, to describe the clinical course of ITP patients becoming infected by SARS-CoV-2 and of COVID-19 patients developing de novo ITP.

Multicenter retrospective and prospective observational study based on the collection - through pre-piloted electronic CRFs - of sequential anonymized data from principal Italian ITP centers representative of national geographical distribution, to evaluate, during a 2-years study period, both the cumulative incidence COVID-19 occurring in patients with prior or ongoing ITP (COVID-19 in ITP) and the cumulative incidence of de novo ITP manifesting during COVID-19 (ITP in COVID-19). Data will be collected to describe the clinical course of patients in the two groups. The enrolment period will last 24 months or terminate at the last day of 1-month-COVID-19 free in Italy, whichever comes first. Each patient will be followed up to the first visit scheduled as per common center practice, including at least six months after hospital discharge or end of quarantine home confinement.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Confirmed diagnosed of ITP (ITP could be past, ongoing, persistent \>3 months, chronic \>12 months) in patients that are in regular follow-up (at least once a year) and who have been diagnosed with COVID-19
* All patients who develop de novo ITP from 1st January 2020 to the end of study after a diagnosis of COVID-19 or during the first 6 months after COVID-19 recovery
* Signed informed consent

Exclusion Criteria:

• All subjects not fitting inclusion criteria