cyrilzakka/clinical-trials huggingface dataset:
High-dose Intravenous Methotrexate Versus Intrathecal Methotrexate for Central Nervous System Prophylaxis in DLBCL

The outcome of patients with central nervous system (CNS) relapse in DLBCL is poor, with median survival times of 2-5 months. This fatal prognosis necessitates CNS prevention in a subgroup of patients with a high risk of CNS relapse.

Intrathecal methotrexate (ITMTX) has traditionally been used, although its efficacy for CNS prophylaxis is contradictory. High-dose intravenous methotrexate (IVMTX) has been suggested as an alternative approach. Considering the lack of evidence supporting the role of ITMTX, the investigators propose to compare the efficacy of ITMTX and IVMTX for prophylaxis of CNS relapse in a subgroup of patients with DLBCL at a high risk for CNS relapse.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years \<80
* Newly diagnosed, histologically confirmed DLBCL
* High-risk of CNS recurrence at diagnosis:

  1. Age-adjusted IPI (aaIPI) ≥2 or IPI ≥4 with extranodal involvement of \>1 site plus serum lactate dehydrogenase (LDH) \> normal OR
  2. Involvement of high-risk locations: bone marrow, nasal or paranasal sinuses, testis, epidural disease (paravertebral or vertebra), breast, adrenal or kidney
* Estimated life expectancy of more than 90 days
* Performance status (ECOG) ≤ 2
* Written informed consent

Exclusion Criteria:

* Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol
* DLBCL or following subtypes:

  1. Primary mediastinal large B-cell lymphoma
  2. Grey zone lymphoma)
  3. Primary cutaneous DLBCL
* Previous immunochemotherapeutic treatment for DLBCL other than short-term use of corticosteroids (≤ 8 days before randomization)
* Previous radiotherapy
* CNS involvement of DLBCL at diagnosis
* HIV positive
* Any contraindication for application of RCHOP or high dose methotrexate
* Any of following laboratory results

  1. Absolute neutrophil count \< 1,500 cells/mm3 (1.5 x 109/L),
  2. Platelet count \< 100,000/mm3 (100 x 109/L), or \< 75,000 /mm3 in patients with bone marrow involvement,
  3. Serum aspartate transaminase or serum alanine transaminase ≥3.0 x upper limit of normal (ULN),
  4. Serum total bilirubin \> 2 x ULN (with the exception of hemolytic anemia),
* Serum creatinine \>2.0 x ULN or creatinine clearance \<50 mL/min
* Active cancer except curable basal cell carcinoma, cervical cancer in situ, and/or papillary thyroid cancer during the last five years
* Ejection fraction \< 45% on echocardiography
* Uncontrolled active hepatitis
* Pregnancy or breast-feeding
* Men and women of reproductive potential no agreeing to use an acceptable method of birth control during treatment
To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China

A real world study to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China Rezūm RWS study

This RWS study is to evaluate the feasibility, preliminary safety and performance of Rezūm system in BPH treatment in China, to generate local real world data from a Chinese BPH population.

The Rezūm System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH. It is indicated for men ≥50 years of age with a prostate volume ≥ 30cm3 and ≤80cm3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

Eligibility Criteria:
Inclusion Criteria:

* The subjects will provide written informed consent form and agree to data collection.
* The subjects who were diagnosed as BPH and treated by Rezūm procedure in Hainan medical pilot zone will be enrolled in this study.

Exclusion Criteria:

* This is a retrospective study without any formal exclusion criteria.
Investigation of Correlation Between Concentrations of Glucose in Blood and Interstitial Fluid in Type 1 Diabetics

This is a mono-centre trial performed at the Center for Clinical Research at the Medical University Graz. There will be a screening information and a study visit.In the study visit arterialized venous blood glucose values will be monitored and subcutaneous sampling of interstitial fluid (ISF) with microdialysis for glucose determination will be performed. Additionally to the laboratory analysis of the subcutaneous glucose samples, the glucose will be measured with extracorporeal on-line sensors and two marketed devices (Guardian RT and Glucoday S).The study visit will last 30 hours starting with the insertion of microdialysis catheters in the abdominal subcutaneous tissue and the insertion of the catheters for the Glucoday S system and Guardian RT system. The primary hypothesis of the study is: Interstitial fluid glucose concentration profiles correlate to the arterialized venous blood glucose concentration profile in type 1 diabetic subjects.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any trial-related activities.
* Skin fold thickness of minimally 5 mm
* Age of patients in the range from 19 to 60 years.
* Type 1 diabetes

Exclusion Criteria:

* Severe acute and/or chronic diseases
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation.
* Taking of any vasoactive substances or anticoagulation medication.
* Diseases of the skin which could interfere with application of the catheters
* Pregnancy or breastfeeding
Estimated Impact of Fungal Colonization in Cystic Fibrosis From Secondary Exploitation of MucoFong Database.

The main objective of the project "MucoFong" (19021906 national french program n which Vaincre La Mucoviscidose participated: N82006/ 351) was to determine the fungi present the respiratory tract of CF patients responsible for either colonization or authentic infectious diseases. The Mucofong data allowed the team to provide for the 1st time national French guidelines for the management of CF sputum mycological analysis (MucoMicrobes work group coordinated by Prof. Plésiat published in 2015 in the REMIC book). Nevertheless, the team has a comprehensive database that it still has to analyze beyond these initial results. The main goal today is to clarify the role of fungi in the lung function degradation of these patients by studying the overall risk and estimated impact of fungal colonization in our cohort.

The material includes data from the followup of the 300 patients (3 visits per patient for which the team collected and verified the biological radiological and clinical data).

Relations between Aspergillus fumigatus or Candida albicans and lung function or clinical outcome of patients will be longitudinally analyzed taking as output variable FEV1, according to bibliography data available.

To assess the attributed fungal risk, the team will focus on the 57 patients de novo colonized by fungi at the second visit. Three physician experts will determine the impact of such fungal colonization on the patient clinical and respiratory parameters.

The expert conclusion concordance and statistical significance will be evaluated using the kappa score.

This project will be realized in collaboration with the groups of Prof. R. Thiebaut (Methodology and Epidemiology Service Bordeaux University Hospital, INSERM U1219 / INRIA SISTM) and Prof. M. Fayon (Department of Pediatrics, Pediatric reference centre) University Hospital of Bordeaux.

Eligibility Criteria:
Inclusion Criteria:

All patients included in the database meet the following criteria:

* Patient whose diagnosis of cystic fibrosis has been validated on the criteria in force,
* Patient usually followed in one of the 7 centers involved in the PHRC,
* Patient aged at least 6 years without an upper age limit,
* Patient benefiting from a mycological assessment carried out in the context of the usual microbiological monitoring (good clinical practice),
* Cystic fibrosis Patient benefiting from a mycological assessment carried out in front of a clinical episode of aggravation requiring biological exploration,
* Patient who has signed informed consent at the time of inclusion,-patient affiliated with a social security scheme.

Exclusion Criteria:

Patients meeting the following criteria were not included in the database:

* Pulmonary transplant Patient,
* Patient or their parents (if the patient is a minor) refusing any participation in the study,
* Major incapable subject, under guardianship or under the protection of Justice,
* Refusal or inability to give informed consent.
Ultrasound to Prevent Leg Wound Complications in Heart Bypass.

The long saphenous vein is traditionally harvested for use as a conduit in coronary artery bypass grafting surgery. Currently, the long saphenous vein is not imaged prior to surgery. This study aims to evaluate preoperative ultrasound mapping of the long saphenous vein to to improve patient and clinical outcomes.

A vein from the leg is widely is widely harvested during coronary artery bypass grafting (CABG) surgery for bypass of diseased coronary arteries. This vein is called the long saphenous vein.

Currently, the long saphenous vein (LSV) is harvested blind by surgical practitioners with no imaging prior to surgery to decide on whether this vein is suitable for use in heart bypass surgery. This can result in fruitless incisions and result in additional unnecessary surgical wounds in the leg(s) to identify a suitable section of vein that can be used in the bypass operation. In these cases, excessive surgical trauma to the leg can increase the risk of a wound infection.

There is some evidence that ultrasound imaging of the LSV improves leg wound outcomes in patients having CABG surgery. Some studies have reported reductions in vein wound infection rates, vein harvest time, length of hospitalisation and length of wounds.

The purpose of this study will be to investigate the potential benefit of ultrasound imaging as a randomised control trial. One group will have ultrasound imaging of the long saphenous vein prior to heart bypass surgery. A second group will not undergo ultrasound imaging which is current practice at the Bristol Heart Institute.

Ultrasound imaging of the long saphenous vein will allow planning and selection of the most optimal segment of vein. This targeted approach will allow guidance of surgical incisions away from unsuitable segments and thus potentially improving leg wound outcomes.

The primary endpoint for this study will be to assess leg wound infection between the two randomised groups. Other endpoints that will be assessed are patient satisfaction, wound length, time taken to remove the vein, blood loss from the leg wound during surgery and the number of wounds in your leg.

Eligibility Criteria:
Inclusion Criteria:

* Listed for CABG surgery with long saphenous vein harvesting.
* Aged over 18 years.
* Capable of providing informed consent.
* Five days or more to consider participation prior to surgery if an outpatient or 2 days if an inpatient referred by their consultant.
* Operative procedure to be undertaken at the Bristol Heart Institute.

Exclusion Criteria:

* Operation within 48h hours if an inpatient or 5 days if an outpatient.
* Aged below 18 years of age.
* Incapable of providing informed consent i.e. confirmed diagnosis of dementia or other mental health conditions or unconscious.
* Current participant in a different randomised control trial.
* Pregnancy
* Active cancer
* Immunosuppressed.
* Non-English speaker that requires a Trust translator.
DuoPACT Pilot Intervention

The investigators will pilot test the intervention by randomizing 30 couples to one of three conditions: 1) DuoPACT, the newly-developed couples intervention; 2) Life Steps, a standardized antiretroviral adherence intervention for HIV+ individuals; and 3) a treatment as usual (TAU) assessment-only control condition. After randomization, intervention sessions will be delivered weekly (6 DuoPACT sessions, or 3 Life Steps sessions). All couples will be assessed pre/post intervention to evaluate intervention acceptability and feasibility.


Eligibility Criteria:
Inclusion Criteria:

1. Gay male couple.
2. One or both partners must be HIV positive and on antiretroviral medications.

Exclusion Criteria:

Must be able to consent to and follow study protocol.
A Study to Evaluate the Drug Levels, Metabolism and Excretion, and Absolute Bioavailability of BMS-986365 in Healthy Male Participants

The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations, as determined by the investigator
* Participants will require a left ventricular ejection fraction of \> 50% at screening.
* Body mass index of 18.0 to 32.0 kg/m2, inclusive, at screening. Body mass index = weight(kg)/(height \[m\])2.

Exclusion Criteria:

* Any current or recent significant acute or chronic illness.
* Participants with a prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QTcF interval (\> 450 ms) at screening.
* Current or recent (within 3 months of intervention administration) gastrointestinal disease that could affect the absorption of study drug including cholecystectomy. Mild gastroesophageal reflux (even if managed with avoidance of food triggers) is exclusionary.
* History of allergy to BMS-986365 or related compounds.

Other protocol-defined Inclusion/Exclusion criteria apply.
Combined Static and Dynamic Orthotic Treatment of the PIP Joint

Study Design: Randomized controlled clinical study. Introduction: Physiotherapeutic intervention aiming to restore mobility using different techniques as stretching, hot packs, exercises, therapeutic ultrasound and orthotics. No scientific evidence has been found correlating improved joint mobility and the use of these techniques. Application techniques of orthoses to reshape the soft tissues have been well detailed, however, no scientific evidence supporting their effectiveness on proximal interphalangeal joint (PIPJ) lag extension resolution using them as a single treatment has been found.

Purpose of the Study: The purpose of the study was to test the effectiveness of static and dynamic orthosis in patients with a PIPJ flexion retraction using them as a single treatment compared with traditional combined therapies.

Method: 63 participants were included in the study. Patients who used splints were compared to a control group who received conventional treatment. Active and passive mobility were measured before the experiment and again three months after. All the patients were measured under the same conditions and treated by the same hand therapist. The relationship between contracture resolution and function was measured using the DASH Spanish Version.


Eligibility Criteria:
INCLUSION CRITERIO:

* 18 years old
* had given their consent
* having suffered trauma to the hand or finger which has resulted in joint damage with a consequent loss of full extension of the PIPJ
* duration of the injury being between four and 30 weeks.

EXCLUSION CRITERIA:

* Patients who had no proper joint alignment,
* Patients those with a presence of nerve or tendon associated dupuytren,
* campodactilea
* tubular bone fractures
* acute inflammatory signs
* joint instability
* avascular necrosis
* infection of the affected finger were not included in the study.
Postoperative Outcomes in Patients With Hepato-biliary-pancreatic Cancer According to inBody Test

postoperative outcomes were evaluated by using inBody test

postoperative outcomes were evaluated by using inBody test

Eligibility Criteria:
Inclusion Criteria:

* surgically treated patients

Exclusion Criteria:

* a body weight loss of \>10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease
Syncope: Pacing or Recording in the Later Years

Syncope affects about 50% of Canadians, is the cause of 1 - 2% of all emergency room visits, and probably is responsible for CDN $250 million in health care spending each year. It is associated with decreased quality of life, trauma, loss of employment, and limitations in daily activities. It is a particular problem for older people, partly because of increased frailty, and partly because of a difficult differential diagnosis. One of the causes in older adults is intermittent complete heart block in the setting of bifascicular heart block, but they may also faint due to a variety of tachyarrhythmias, sick sinus syndrome, and several neurally mediated syncopes. Often treatment decisions should be made before the true cause is apparent.

There are two general approaches to the patient with syncope and bifascicular block, a common substrate for intermittent heart block. The first is to assume that intermittent heart block is the cause, and simply implant a pacemaker. The second is to implant a digital ECG loop recorder with a lifespan of 2 - 3 years, determine the rhythm abnormalities during the next faint, and treat accordingly. Both approaches expose patients to a risk of fainting and its sequelae, and both carry device-related complications.Which approach is superior is unknown.

Eligibility Criteria:
Inclusion Criteria:

-Patients are eligible if they have:

* \>1 syncopal spell within 1 year preceding enrollment, and
* bifascicular block on a 12-lead ECG, and
* Age \> 50 years and
* written informed consent. Syncope will be defined based on history using a standardized form.

Exclusion Criteria:

-Patients will be excluded if they have criteria related to study strategies, including:

1. previous pacemaker, ICD, or Implantable Loop Recorder in situ,
2. ACC/AHA/HRS Class I indication for permanent pacing or ICD implantation,
3. left ventricular ejection fraction \< 35% mandating ICD therapy,
4. contra-indication to a transvenous pacemaker such as artificial tricuspid valve or active sepsis.

   -Patients will also be excluded if a potential competing cause of syncope poses a threat to life, such as:
5. hypertrophic cardiomyopathy,
6. documented sustained ventricular tachycardia or
7. inducible, sustained monomorphic ventricular tachycardia on EP study.

   -They will be excluded if they have:
8. a history of myocardial infarction within 3 months prior to enrollment, and
9. a major chronic co-morbid medical condition that would preclude 24 months of follow-up.
Pharmacodynamics, Safety/Tolerability and Efficacy of Topical Omiganan in Patients With uVIN

To assess the pharmacodynamics, safety/tolerability and efficacy of topical Omiganan (CLS001) in patients with usual type vulvar intraepithelial neoplasia (uVIN).


Eligibility Criteria:
Inclusion Criteria:

1. Women ≥ 18 years
2. Biopsy proven uVIN, biopsies to have been taken within the last three months
3. Written informed consent to participate in the trial
4. At least one lesion that can be accurately measured (using RECIST criteria)

   * in at least one dimension with longest diameter ≥ 20mm
   * OR in two perpendicular dimensions that when multiplied together give a surface area of ≥ 120mm2 (e.g. 15mm x 8mm or 12mm x 10mm)
   * This is to ensure that 4x4mm biopsies can be performed on this lesion.

Exclusion Criteria:

1. Has any concomitant disease or significant medical conditions that would, in the opinion of the Investigator, potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical trial.
2. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis) or ECG. In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
3. Indication of a current active infectious disease of the vulva, other than HPV
4. Pregnant, breast feeding or trying to conceive
5. Active treatment for uVIN (i.e. surgical excision, lasertherapy, imiquimod, photodynamic therapy) within the previous month
6. Patients receiving immunosuppressive therapy
7. HIV positive or transplant patients
8. Any condition that in the opinion of the investigator could interfere with the conduct of the study
Effects of EMDR Therapy in Patients With Severe Obesity

The aims of the study are to perform psychological intervention using EMDR Therapy (Eye Movement Desensitization and Reprocessing Therapy) in the preoperative period, evaluate the personality of each patient through the PFB test (Personality Factor Battery Test) at different times, compare the results obtained in the PFB test at different times of application and verify the existence of changes in the five major Personality Factors: Neuroticism, Extroversion, Socialization, Realization and Openness.

Obesity is a multi-factorial disease requiring a multi-professional approach. Psychological causes also contribute to the development and maintenance of obesity. Traumatic experiences may be a risk factor for it as well. Emotional issues of obese patient often interfere with the results of bariatric surgery, where a large number of bariatric patients regain the weight or change symptoms.

The aim of the Effects of EMDR therapy with Severe Obesity Bariatric Surgery Patients randomized controlled trial is to determine the effects of 11 sessions of EMDR therapy, prior to surgery as compared to a control group. The Big Five personality factors will be used to evaluate the results. Both groups of patients will complete the Factorial Personality Battery, before the surgery, and 6 months and 12 months following bariatric surgery.

The initial hypothesis is that EMDR therapy will provide sufficient changes after surgery in the personality dynamics of obese patients, which will in turn favor emotional balance and weight maintenance as compared to the control group.

Eligibility Criteria:
Inclusion Criteria:

* both sexes
* BMI between 40 Kg/m2 and 50 Kg/m2
* ages between 30 and 55 years,
* minimum level of Elementary School, previously evaluated psychologically by the Psychology Service - University of São Paulo Medical School

Exclusion Criteria:

* history of severe personality disorders: psychotic symptoms or schizophrenia; bipolar disorder or dementia - groups A and B (DSM - IV);
* patients who present severe dissociative disorders (score above 25%), evaluated through the Dissociative Experiences Scale (DES);
* patients with heart problems and current pregnancy, with information obtained through the participants' reports.