cyrilzakka/clinical-trials huggingface dataset:
Diagnostic Study of Patients With Aggressive Non-Hodgkin's Lymphoma

RATIONALE: Determination of genetic markers for aggressive non-Hodgkin's lymphoma may help identify patients with this disease and help predict the outcome of treatment.

PURPOSE: Diagnostic study to determine the genetic markers in patients who have aggressive non-Hodgkin's lymphoma.

OBJECTIVES:

* Estimate the proportions of patients with diffuse aggressive non-Hodgkin's lymphoma who have rearrangements affecting the MYC, BCL2, and BCL6 genes (determined by fluorescent in situ hybridization), overtly amplified chromosomal regions, and nonrandom copy number changes of chromosomal regions (determined by comparative genomic hybridization).
* Investigate the prognostic importance of these genetic markers by studying their relationships with clinical outcomes (e.g., response to therapy, failure-free survival, and overall survival) in these patients.
* Investigate the interrelationships among these genetic and biological markers and their relationships with clinical features of the disease, such as disease site (nodal vs extranodal) and stage, in these patients.

OUTLINE: This is a multicenter study.

Tissue samples are obtained before treatment and at the time of documentation of refractory disease in patients who do not achieve complete remission after induction therapy or at the time of first relapse in patients who achieve a complete remission.

Samples are examined for rearrangements in the MYC, BCL2, BCL6, and IGH genes using fluorescent in situ hybridization. DNA is examined by comparative genomic hybridization, which allows cytogenetic detection of losses and gains of chromosomal regions in tumor cells.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven aggressive non-Hodgkin's lymphoma and registered to front-line CALGB protocols (e.g, CLB-59903, 59909, 10002, and 50103)

  * Diffuse small cleaved cell lymphoma
  * Diffuse mixed small and large cell lymphoma
  * Diffuse large cell lymphoma
  * Diffuse large cell immunoblastic lymphoma
  * Small noncleaved cell lymphoma
  * Mantle cell lymphoma OR
* Previously entered on similar curative CALGB protocols (CLB-8852, CLB-8854, and CLB-9351) with blocks or unstained slides of initial diagnosis available

PATIENT CHARACTERISTICS:

Age:

* 18 years and older
Immunotherapy of HLA-A2 Positive Stage III/IV Melanoma Patients

The purpose of this study is to determine whether vaccination with tumor antigenic peptides and both CpG and Montanide adjuvants can induce an immune response in melanoma patients and to assess the safety of this vaccination.

Immune therapy with tumor antigenic peptides is generally quite well tolerated. However, immune activation is often only weak or even undetectable, and clinical responses (supposedly corresponding to protective immunity) are unfortunately infrequent. Further progress is required to improve the vaccines, with the goal to increase the strength of immune activation.

The tumor antigenic peptides Melan-A/Mart-1 (EAA and ELA) and Tyrosinase (YMD) are combined with two drugs in this study, both of which are known to enhance immune responses: first, CpG 7909 oligodeoxynucleotides, and second, Montanide ISA-51.

* Group 1: vaccination with Melan-A analog peptide + CpG and Montanide adjuvants;
* Group 2: vaccination with Melan-A natural peptide + CpG and Montanide adjuvants;
* Group 3 : vaccination with Melan-A natural and Tyrosinase peptides + CpG and Montanide adjuvants;
* Group 4 : vaccination with Melan-A analog and Tyrosinase peptides + CpG and Montanide adjuvants.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed stage III or stage IV melanoma
* Tumor expression of Melan-A +/- Tyrosinase
* Human leukocyte antigen-A2 (HLA-A2) positive

Exclusion Criteria:

* Clinically significant heart disease
* Serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders or uncontrolled peptic ulcer, or seizure or central nervous system disorders
* History of immunodeficiency disease or autoimmune disease
* Coagulation or bleeding disorders
Outcomes Of The Different Techniques Of Male Circumcision

Aim of work:

The aim of study is to comprehensively evaluate and compare the efficacy, safety, clinical outcomes, cosmetic appearance and complication rates associated with different technique of circumcisions.

The aim of study is to comprehensively evaluate and compare the efficacy, safety, clinical outcomes, cosmetic appearance and complication rates associated with different technique of circumcisions.

Patients and methods:

According to the method of circumcision used; infants were divided into 5 groups :

1. Group A: Conventional dissection technique;
2. Group B: Bone cutting ;
3. Group C: Electro-cauterization (bipolar) assisted circumcision;
4. Group D: Thermal cauterization assisted circumcision;
5. Group E: Gomco clamp technique;
6. Group F: Plastibell device technique. Place of the study: The study will be held in the department of Pediatric surgery at Sohag University Hospital.

Type of the study: Prospective comparative Cohort study. Duration of the study: The study lasts for 6 months from the acceptance of the protocol (december 2024) to (Jone 2025).

Inclusion criteria:

All uncircumcised boys with intact prepuce aged below 15 years presented at our department for routine circumcision or for medical indications.

Exclusion criteria:

1. Age above 15 years
2. Ambiguous genitalia
3. Congenital penile anomalies e.g. hypospadias, epispadias, buried penis, webbed penis, micropenis, congenital chordee, incomplete prepuce and mega-urethra.
4. Redo-circumcision
5. Balanitis or inflammatory process around the penis.
6. Bleeding disorders; hemophilia or thrombocytopenia

Eligibility Criteria:
Inclusion Criteria:

1. All uncircumcised boys with intact prepuce
2. Age below 5 years presented at our department for routine circumcision or for medical indications.

Exclusion Criteria:

1. Age above 5 years
2. Ambiguous genitalia
3. Congenital penile anomalies
4. Redo-circumcision
5. Balanitis or inflammatory process around the penis.
6. Bleeding disorders
Detecting Dopaminergic Deficits in Individuals At-risk for Parkinsonism

The purpose of this study is to determine if participants have changes in dopamine cells in their brain using DaTSCAN™ brain imaging. Dopamine cell loss occurs in Parkinson's disease (PD) and other degenerative Parkinsonian disorders, but does not occur in most other movement disorders such as essential tremor or dystonia. DaTSCAN, which is also known as 123I-Ioflupane, is a new compound that has been developed by General Electric, Inc. and has been approved by the US Food and Drug Administration (FDA) to help doctors detect changes in dopamine. This test is performed by injecting DaTSCAN into a vein in the arm, and after a few hours, a large amount of DaTSCAN temporarily accumulates in an area of the brain where there are a lot of dopamine brain cells. Because DaTSCAN contains a small amount of radioactive iodine, it allows doctors to use a special machine called single photon emission computed tomography (SPECT) scanning to detect the location and amount of radioactivity in the brain and help determine if there are changes in brain dopamine. It is hoped that this study will help doctors detect the presence of dopamine changes even before symptoms are present. This study will evaluate DaTSCAN in people with PD, those who are at risk for developing PD (e.g., those with idiopathic rapid eye movement sleep disorder (iRBD) and those who are heterozygous or homozygous for Gaucher's disease (GBA) mutations) and those who are healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Written consent prior to study by the subject or their surrogate
* Subjects \>/= 18 years and\</=85 years
* Diagnosis of Parkinson's disease, family history of Parkinson's disease, idiopathic rapid eye movement sleep behavioral disorder, age-matched controls, Gaucher's disease or carrier of Gaucher's gene mutation
* Females using adequate methods of birth control or not of childbearing potential

Exclusion Criteria:

* Any clinically significant acute or unstable physical or psychological disease based on medical history or screening physical examination
* Any exposure to investigational drugs within 4 weeks prior to Visit 1
* Any exposure to radiopharmaceuticals within 4 weeks prior to Visit 1
* Pregnancy
* Breastfeeding
* Severe swallowing problems
* Known sensitivity or allergy to iodine containing products
* Advanced liver or renal disease
Total Robotic Versus Robotic Assisted Distal Gastrectomy for Gastric Cancer

To evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of total robotic versus robotic assisted distal gastrectomy for patients with gastric cancer (cT1-4a, N0/+, M0).

In the field of gastrectomy, Hashizume et al. first reported robotic gastrectomy in 2002. Since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (GC) have gradually increased. Reports of robotic surgery for GC are increasing, especially in Asia. Several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. However, whether total robotic gastrectomy is noninferior to robotic-assisted gastrectomy remains unclear. The investigator first carried out this study in the world to evaluate the efficacy of total robotic versus robotic assisted distal gastrectomy for GC.

Eligibility Criteria:
Inclusion Criteria:

1. Age from over 18 to under 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. cT1-4a (clinical stage tumor), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition
4. expected to perform distal gastrectomy with D1+/D2 lymph node dissection to obtain R0 resection surgicall results.
5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
6. American Society of Anesthesiology (ASA) class I to III
7. Written informed consent

Exclusion Criteria:

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastric surgery (except Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection (ESD/EMR) for gastric cancer)
5. Gastric multiple primary carcinoma
6. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative imaging
7. History of other malignant disease within the past 5 years
8. History of previous neoadjuvant chemotherapy or radiotherapy
9. History of unstable angina or myocardial infarction within the past 6 months
10. History of cerebrovascular accident within the past 6 months
11. History of continuous systematic administration of corticosteroids within 1 month
12. Requirement of simultaneous surgery for other disease
13. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
14. Forced expiratory volume in 1 second (FEV1)\<50% of the predicted values
Effect of Motor Rehabilitation Treatment on Amyotrophic Lateral Sclerosis (ALS)

ErmoSLA is a multicentric, randomized, controlled trial to compare effects of an "intensive" or "standard" motor rehabilitation treatment on motor disability in people with ALS

The study is a multicentric, randomized, controlled trial to compare effects of standard versus intensive motor rehabilitation treatment for people with ALS.

Eligible patients are going to be randomly assigned to the Standard or Intensive treatment (controlling for ALSFRSR rates at enrollment, age and site of onset). Randomization ratio is 1:1.

Standard treatment: 2 sessions/week of motor rehabilitation treatment (45 minutes each one) for 10 weeks for a total of 20 sessions. The program consists of exercises for aerobic endurance, reinforcement at low load and stretching. At the end of the 20 sessions patient and caregiver are going to continue activity with supervision through regular follow up.

Intensive treatment is characterized by an increased volume of the above mentioned exercises: 5 sessions/week (45 minutes each one) for 10 weeks for a total of 50 sessions. At the end of the 50 sessions patient and caregiver are going to continue activity with supervision through regular follow up.

Collection and analysis of data

Recruitment: during the first 18 months of the study. Outcome measures: evaluated at T0-T3-T6-T9-T12-T15-T18-T21-T24. Rating scales will be administered by a neurologist in singe blind method with respect to the treatment.

Data collection will be done through an ad hoc Case Report Form and entered into a database on a dedicated website.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of possible, probable or definite ALS according to the Revised El Escorial Criteria
* Time from diagnosis \<18 months at screening.
* Forced vital capacity (FVC)\> 50% at screening
* Written informed consent

Patients will be required to take the full dose of Riluzole, but not assuming Riluzole do not constitute a criterion for exclusion.

Exclusion Criteria:

* Enrolment in any other clinical trial in the three months prior to screening
* Tracheostomy or NIV for\> 23h/day for 14 consecutive days at screening.
* Diagnosis of severe neurodegenerative diseases in addition to the ALS
* Diagnosis of severe heart disease, current neoplasia, any unstable medical condition that contraindicates an intensive rehabilitation treatment
* State of pregnancy or breastfeeding
* Residency outside Emilia-Romagna Region
* Lack of multidisciplinary follow-up
Efficacy and Safety Evaluation of Paxlovid for COVID-19: a Real-world Case-control Study

COVID-19 is currently one of the serious public health challenges worldwide, and there is a great need to develop effective treatments. Paxlovid is a Pfizer-developed oral new drug for the treatment of COVID-19. Paxlovid, which is used to treat adult patients with mild to moderate COVID-19 who have high-risk factors for progression to severe disease, was conditionally approved for marketing in the United States and China in December 2021 and February 2022, respectively. Clinical trials have shown that this drug can significantly reduce the progression from mild to severe disease and the rate of hospitalization and mortality. However, due to the limitations of clinical trials in the subject selection, there is still insufficient knowledge about the efficacy and safety of Paxlovid in a real-world population. Relevant studies on this drug in real-world people, especially in Chinese populations, have not been reported. Therefore, this study was designed to investigate the efficacy and safety of Paxlovid on sufferers of COVID-19 through a retrospective, real-world analysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed COVID-19 who had taken more than one dose of Paxlovid.

Exclusion Criteria:

* Age \< 18 years-old;
* Pregnancy;
* Data missing \> 20%.
Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence

This project aims to offer autologous muscle-derived progenitor cell injection as an efficient mini-invasive surgical therapy that would be simple for the patient and could be used in a majority of cases, including in young women in the post-partum. This approach may provide efficient tissue repair of the striated anal sphincter which is not permitted by existing therapies. This innovative therapy may ultimately be proposed after failure of the common treatments and before an high-risk invasive surgical intervention. Besides, injection of muscle-derived progenitor cells in animals has shown very encouraging results of the sphincter function assessed ex vivo. Hence, a high benefit may be expected with this approach.

after verification of information and inclusion criteria. patients were randomized to treatment or placebo arms and receive the injections.

an evaluation of the function and quality of life are realized. after a period of 6 months, patients in the placebo arm receive the injection of myoblasts that have been preserved.

Eligibility Criteria:
Inclusion criteria

* age between 20 and 65 years
* severe fecal incontinence from at least three months
* Jorge et Wexner score ≥ 10
* incontinence refractory to medical treatment and to reeducation from at least three months
* incontinence due to lesion of the external anal sphincter
* incontinence without significant anal sphincter rupture or rupture ≤ 30% of circumference assessed by endo-anal ultra-sonography
* integrity or not of the internal anal sphincter
* fecal incontinence with normal rectum capacity (maximum tolerable volume ≥ 150 ml assessed by ano-rectal manometry)
* fecal incontinence without associated rectal static disorder on defeco-MRI
* fecal incontinence without bilateral complete neuropathy assessed by electro-physiology

Exclusion criteria

* fecal incontinence with rupture \> 30 % of the external anal sphincter
* fecal incontinence with bilateral lesions on the sacral nerves
* Crohn's disease or ulcerative colitis
* unstable type 1 or type 2 diabetes
* myopathy
* peripheral or central neurological diseases
* treatment with laxatives, suppositories or enema
* practice of anal intercourse except if stopped during the study
* treatment with immunosuppressive or cytostatic drugs, CoA HMG reductase inhibitors, morphine derivatives
* treatment of constipation or rectal dyschesia
* pregnancy or breast-feeding,lack of effective contraception during the study (female)
* allergy to antibiotics (cephalexin, metronidazole)
Randomized Clinical Trial in Parkinson's Disease Patients Using Pluripotent Adipose Stem Cells (PASCs)

The purpose of this study is to assess the safety and efficacy of allogenic pluripotent stem cells isolated from adipose tissue (PASCs) in patients with Parkinson's Disease.

Pluripotent Adipose-Derived Stem Cells (PASCs) will be delivered intravenously at a dosage of 25 million PASCs/patient to Parkinson's Disease patients for three infusions each spaced 3 months apart (0, 3, and 6 months). Safety and efficacy of PASC treatment will be monitored over 0, 1, 3, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Men ≥18 years of age or women ≥45 years of age
2. Written informed consent
3. Receiving drug treatment for diagnosis of mild to moderate Parkinson's Disease
4. Modified Hoehn and Yahr stage 1, 2, or 3
5. Diagnosed with Parkinson's Disease for more than 5 years
6. Stable treatment regimen that has not been modified in the 90 days prior to the start of the study
7. No expected addition of symptomatic therapy for at least one year after the start of the study
8. Women of reproductive age must use contraceptive treatment

Exclusion Criteria:

1. Drug-induced Parkinsonism
2. Parkinsonism associated with stroke, progressive supranuclear palsy, Lewy body disease, corticobasal degeneration, or multiple system atrophy
3. Major psychiatric comorbidity that prevents ensuring study follow-up
4. History of alcohol or drug use
5. History of brain surgery for Parkinson's Disease
6. Serious complications deemed inappropriate by Principal Investigator
7. Diagnosis of advanced-stage medical conditions (chronic liver injury with Child-Pugh B or higher, chronic obstructive pulmonary disease with Gold C or higher, or heart failure with ejection fraction \<35%)
8. Use of cytostatic drugs
9. Patients with life expectancy \< 6 months
10. Diabetes mellitus with poor metabolic control (HbA1c \> 8%)
11. Active infectious disease requiring medical treatment
12. Use of systemic steroids or immunosuppressive drugs
13. Patients positive for Hepatitis B antigen, Hepatitis C antibody, or HIV antibody
14. Fertile, pregnant, possibly pregnant, or lactating women
15. History of active mesenchymopathies
16. Active malignancy or diagnosis of malignancy in the last 5 years
17. Abnormal laboratory values, including:

    * AST \>1.5 times Upper Limit of Normal (ULN) (Normal Range: 8 to 48 Units/L)
    * ALT \>1.5 times ULN (Normal Range: 7 to 55 Units/L)
    * Bilirubin \>1.5 times ULN (Normal Range: 0.2 to 1.2 mg/dL)
    * Creatinine \>1.5 times ULN (Normal Range: 0.5 to 1.30 mg/dL)
    * Hematocrit significantly outside normal range (36% to 54%)
    * Lymphocytes significantly outside normal range (103 to 4.8 x 103 lymphocytes/μL)
    * Monocytes significantly outside normal range (200 to 800 lymphocytes/μL)
    * Neutrophils significantly outside normal range (2.5 x 103 to 7 x 103 lymphocytes/μL)
    * Erythrocytes significantly outside normal range (4.7 x 106 to 6.1 x 106 lymphocytes/μL)
    * Platelets significantly outside normal range (150 x 103 to 450 x 103 lymphocytes/μL)
Determination of Scapulothoracic and Glenohumeral Angles by Imaging in Patients After Shoulder Arthroplasty (SCAP-imag)

The shoulder is a site particularly affected by osteoarthritis since it affects up to 7% of the population aged over 65. To deal with osteoarthritis, total shoulder prosthesis is an increasingly used solution. Among the different types of total shoulder prostheses, the majority of surgical procedures involve the use of a reverse total shoulder prosthesis. This type of prosthesis modifies the anatomy of the shoulder in order to ensure better stability and mobility of the shoulder in patients while also compensating for potential significant lesions of certain deep muscles of the shoulder joint (i.e., rotator cuff).

Reverse prostheses have good short-term results but these are impaired in longer term with a Constant functional score of around 70% at 10 years and a survival rate of 70% after 20 years. Problems of bone conflicts between the scapula and the humerus can also be observed on these reverse total shoulder prostheses with variable rates from 4.6% to 47.3% depending on the position of the prosthesis.

In order to minimize the risk of complications, several tools are available to surgeons to optimize the positioning of the prosthesis. Planning software can be used to plan the kinematics of the shoulder after arthroplasty and quantify shoulder movements by 1/ estimating the scapulothoracic and glenohumeral angles, and 2/ determining the scapulohumeral rhythm (i.e., joint coordination index evaluating the relative contribution of these two joints to the total elevation of the arm). This prediction allows the surgeon to adapt the size, shape and position of the implants to each patient in order to ensure optimal shoulder kinematics, namely a maximum amplitude without bone conflicts (contacts) between the scapula and the humerus.

The main objective of this study is to evaluate the influence of a reverse shoulder arthroplasty on shoulder kinematics at 2 years postoperatively in comparison with the non-operated contralateral limb.


Eligibility Criteria:
Inclusion Criteria:

* Major
* Reverse total shoulder arthroplasty surgery performed by Dr. Lionel Neyton (Jean Mermoz Private Hospital,69008 Lyon) 24±3 months prior to inclusion in the study.
* Have had a CT scan of the operated shoulder prior to the operation
* Patient having signed informed consent
* Patient affiliated to a social security scheme or beneficiary of such a scheme, according to Article L.1124-1 of the Public Health Code

Exclusion Criteria:

* Contraindication to the EOS® examination
* Anthropometry incompatible with the production of EOS images
* Pregnant, parturient, breastfeeding women
* Have a history of fracture at the level of the humerus, scapula or clavicle
* Have a history of surgery on the shoulder or contralateral upper limb to the limb with the prosthesis
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision