cyrilzakka/clinical-trials huggingface dataset:
Creating a Tissue Bank of Knee Capsules

A contracture is a pathological condition limiting range and function of joints. Contractures of large and small joints alike will affect one's ability to independently perform daily activities such as eating, dressing or walking. Current treatments for contractures include physical stretching, the use of assistive devices or, rarely, surgery. Despite prolonged treatments, patients with contractures rarely regain complete mobility. Progress in preventing and treating contractures will be possible only through an understanding of the biological and molecular processes involved. Our group has established and validated an animal model to study the histological events and the molecular mechanisms involved in joint contractures. We have provided evidence for capsule stiffness, characterized cartilage degeneration, and identified four genes whose expression is altered in the cartilage of a knee joint with contracture. The work we propose in the current study aims at finding genes and pathways in the joint capsule associated with knee joint contractures. The results will identify new avenues for treating the large number of patients suffering from contractures.

We propose to constitute a bank of capsule samples from people with osteoarthritis undergoing primary total knee arthroplasty. It is expected that about 1.3% of people will develop a contracture post arthroplasty. A second sample will be taken from those that require surgery for release of contracture or revision. We will study histological characteristics and compare gene expression between the primary sample and the contracture sample in the same patient. In order to determine whether intrinsic genetic factors influence the develpment of joint contractures in the osteoarthritis population, all specimens will be analyzed for differential gene expression between patients with and without knee contractures post arthroplasty.

The remaining capsule tissue not used for this study will be banked and made available to other researchers.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis, booked for a total knee arthroplasty

Exclusion Criteria:

* Transmissible disease (e.g., HIV infection, hepatitis B or C)
* Suspected neoplasia
* Suspected infection (which can cause arthrofibrosis)
* Hypertrophic scarring
Combining Intratumoral Metabolic Heterogeneity and Dissemination Feature (Dmax) on 18F-FDG PET/CT Improves Prognosis Prediction in DLBCL

This retrospective study aimed to investigate the combined prognostic values of intratumoral metabolic heterogeneity (MH), disseminate feature (Dmax) and total metabolic tumor volume (TMTV) by 2-deoxy-2-\[18F\]fluoro-D-glucose positron emission tomography/computed tomography (\[18F\]FDG PET/CT), and establish novel nomograms to improve prognosis prediction in diffuse large B-cell lymphoma (DLBCL)

This retrospective study aimed to investigate the combined prognostic values of intratumoral metabolic heterogeneity (MH), disseminate feature (Dmax) and total metabolic tumor volume (TMTV) by 2-deoxy-2-\[18F\]fluoro-D-glucose positron emission tomography/computed tomography (\[18F\]FDG PET/CT), and establish novel nomograms to improve prognosis prediction in diffuse large B-cell lymphoma (DLBCL)

Patients would be retrospectively includedin this study.The inclusion criteria included (1) pathologically proven DLBCL; (2) first-line treatment with R-CHOP or R-CHOP-like chemotherapy including R-miniCHOP and R-ECHOP (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin); (3) at least 2 evaluable hypermetabolic lesions on PET/CT;(4) underwent pre-treatment \[18F\]FDG PET/CT.

Eligibility Criteria:
Inclusion Criteria:

* (1) pathologically proven DLBCL, (2) first-line treatment with R-CHOP or R-CHOP-like chemotherapy including R-miniCHOP and R-ECHOP (rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin),(3) at least 2 evaluable hypermetabolic lesions on PET/CT, (4) underwent pre-treatment \[18F\]FDG PET/CT

Exclusion Criteria:

* (1) patients who had received surgical resection or other treatments before chemotherapy, (2) patients who had coexistent central system lymphoma or other types of malignancies
Study to Evaluate the Testicular Safety of Filgotinib in Adult Males With Moderately to Severely Active Inflammatory Bowel Disease

The primary objective of this study is to evaluate the testicular safety of filgotinib in adult males with moderately to severely active inflammatory bowel disease (IBD).

Results of this study may be pooled with the results of a separate study being conducted in participants with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis (Protocol GLPG0634-CL-227; NCT03926195) with the same objective. The total planned number of participants in both studies combined will be up to approximately 250 participants.

There are 5 parts to the study: 1) Part A: Double-Blind Phase (DB Phase; Day 1 through Week 13); 2) Part B: DB Phase (after Week 13 through Week 26); 3) Open-label (OL) Filgotinib Phase (after Week 13 study visit for up to 13 weeks); 4) Monitoring Phase (MP; up to 52 weeks); and 5) Long-term Extension (LTE) Phase (after Week 26 or end of OL Filgotinib Phase for up to 195 weeks).

Eligibility Criteria:
Key Inclusion Criteria:

* Documented diagnosis of ulcerative colitis (UC) or Crohn's Disease (CD) of at least 4 months. Endoscopic and histopathologic documentation of UC or CD.
* Have moderately to severely active UC or CD

Key Exclusion Criteria:

* Previously or currently documented problems with male reproductive health
* Current use of sulfasalazine or its use within the 26 weeks leading up to Screening; sulfasalazine is not permitted at any point during the study
* Current use of corticosteroids at a dosage of \> 20 mg/day of prednisone or equivalent at randomization
* Indeterminate colitis, ischemic colitis, fulminant colitis, isolated ulcerative proctitis, or toxic mega colon
* Active tuberculosis (TB) or untreated latent tuberculosis
* Use of concomitant prohibited medications as outlined by protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Urinary Retention in Orthopedic Patients

The participants were hospitalized in Orthopedic and Traumatology Departments in Military Institute of Medicine, Warsaw, Poland.

The inclusion criteria were (1) age to 40 year-old, (2) no history of urologic problems, and (3) surgery under spinal anesthesia. All the patients where (1) opioids were administered during the surgery, (2) general anesthesia was necessary, and (3) the urinary bladder catheterization was perform during the surgery were excluded from the study.

The participants were randomly divided into the study and control groups. No oral premedication was administered. All the patients were asked to empty their urinary bladders before arrival to the operating theatre. When the standard monitoring (continuous electrocardiogram, noninvasive blood pressure, pulse oximetry) was started, intravenous premedication with midazolam was administered and lumbar spinal anesthesia with hyperbaric 0.5% solution of bupivacaine hydrochloride was performed.

In the study group, but not in the the control one, the 40 mg of drotaverine hydrochloride was administered intramuscularly. The decresed intravascular volume was corrected with cristalloids. During the surgery the adequate, not deeper than II grade according to Ramsay scale, level of sedationt was obtained with midazolam and/or propofol. All the participants received a questionaire in which we asked the questions about (1) the duration of anesthesia, (2) the time of micturition, (3) the time when discomfort or pain appeared in the lower abdomen, (4) the incidence of the urinary bladder catheterization and time to catheterization. On the next day after the surgery the questionaires were collected. In cases, when the patient's dischaged from the hospital was planned during the weekend, he or she was asked to pass on the questionaire to the nurses.


Eligibility Criteria:
Inclusion Criteria:

* age below 40 y.o.,
* surgery under spinal anesthesia,
* no previous history of urological problems.

Exclusion Criteria:

* opioid administration during surgery,
* need for urinary bladder catheterization during surgery,
* conversion to general anesthesia.
Individualized Locoregional Treatment of Initially Biopsy-proven Node-positive Breast Cancer After Primary Systemic Therapy

In clinically node-positive (cN+) breast cancer, preoperative systemic therapy (PST) is common. With increasing rates of complete tumour eradication, there is a need for de-escalation of locoregional treatment in the interest of decreased morbidity.

In order to individually adapt postoperative therapies, axillary staging is crucial. Axillary lymph node dissection (ALND) comes at a high risk of arm morbidity. There is extreme divergence in the use of less extensive staging methods, i.e. targeted lymph node biopsy (TLNB), sentinel node biopsy (SNB) or both (TAD), and in the use of subsequent locoregional treatment, since prospective data are largely lacking.

The main purpose of the European INDAX trial is to implement de-escalated staging and evaluate which regional treatment, individually adapted to the response after PST, is oncologically safe but least harmful.

Population: cN+ breast cancer patients receiving PST, recruited 2021-2025. Staging by TLNB, TAD or SNB.

Intervention: Negative staging (ypN0, Randomisation A, N=1433): no regional treatment. Positive staging (ypN+, Randomisation B, N=1513): no ALND but regional radiotherapy (rRT).

Control: Randomisation A: rRT only. Randomisation B: ALND plus rRT.

Outcome: Invasive disease-free survival (non-inferiority), arm morbidity and quality of life.

Drug tests in whole-tumour organoid cultures, algorithm-based digital image analysis and gene expression analysis are performed to improve response prediction, facilitate tailoring of PST and increase eradication rates.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary invasive breast cancer cT1-cT3
* cN1 status prior to PST
* Cytological or histological proof of axillary metastasis before PST
* Full tumour biology available before initiation of PST
* Oral and written consent
* Age ≥ 18 years

Exclusion Criteria:

* Biopsy-confirmed regional nodal metastases outside of the ipsilateral axilla
* Distant metastases at diagnosis
* Inflammatory breast cancer
* Previous axillary surgery
* Previous radiotherapy to ipsilateral breast, chest or axilla
* History of prior invasive breast cancer
* Ongoing pregnancy or breast-feeding
* Bilateral invasive breast cancer
* Medical contraindication for radiotherapy or inability to receive recommended radiotherapy
* Medical contraindication for adjuvant endocrine treatment, if indicated
* Inability to absorb or understand the meaning of the study
Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896)

This is a non-interventional study designed to evaluate the efficacy and safety of combination study drugs in the treatment of participants diagnosed with Chronic Hepatitis C (CHC). CHC participants with confirmed positive hepatitis-C virus (HCV) RNA in plasma, and who have not been previously treated with the Pegylated interferon (PegIntron) Pen, were enrolled into study.

Participants with positive genotype-1 HCV RNA received 48 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants who were non-genotype-1 HCV RNA positive received 24 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants were asked to complete a questionnaire to measure the satisfaction and the use of training materials of PegIntron pen using a 1-5 score system provided in the questionnaire. The questionnaire was completed once at first follow-up visit. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 of treatment and at week-24 of follow-up in positive Non-genotype-1 HCV RNA participants. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 and at week-48 of treatment, and at week-24 of follow-up, for positive Genotype-1 HCV RNA participants.

Eligibility Criteria:
Inclusion Criteria:

* Demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent.
* Equal to or greater than 18 years.
* Confirmed chronic hepatitis C with hepatitis C virus (HCV) RNA positive in plasma.
* No previous use of PegIntron Pen.

Exclusion Criteria:

* Hypersensitivity to the active substance or to any interferon or to any of the excipients.
* Pregnant women.
* Women who are breastfeeding.
* Existence of or a history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicide attempt.
* A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months.
* Severe debilitating medical condition, including patients with chronic renal failure or creatinine clearance \< 50 ml/minute.
* Auto immune hepatitis or a history of autoimmune disease.
* Severe hepatic dysfunction or decompensated cirrhosis of the liver.
* Pre-existing thyroid disease unless it can be controlled with conventional treatment.
* Epilepsy and/or compromised central nervous system (CNS) function.
Personalized Management of Body Weight During Pregnancy

The purpose of this study is to determine how to help manage weight gain during pregnancy. This study is part of the National Consortium 'LIFE-Moms: Lifestyle interventions in expectant moms'. LIFE-Moms is 7 studies funded to test different lifestyle interventions in overweight and obese pregnant women.

The study will last 22 months, from screening until study completion. The entire study will include 3 screening visits, receipt of weight management advice, second trimester testing, third trimester testing and three follow up visits during the first year after the baby is born. Participants will randomly be assigned to 1 of 3 programs to help manage their weight during pregnancy:

1. Physician Directed group
2. SmartMoms-Clinic group
3. SmartMoms-Phone group

Eligibility Criteria:
Inclusion Criteria:

* Are pregnant.
* Are between 18 and 40 years old.
* Have a BMI (a number calculated from your height and weight) equal to or above 25kg/m2.
* Establish prenatal care before 12 weeks of your pregnancy.
* Can read, speak and understand English.

Exclusion Criteria:

* Do not plan to deliver your baby at Woman's Hospital, Baton Rouge, LA
* Are pregnant with more than one infant.
* Have habitually smoked during the last 6 months.
* Currently abuse or have abused illegal or prescription drugs in the last 6 months.
* Consume more than 2 alcoholic drinks per week.
* Are unwilling to avoid pregnancy for 12 months following delivery.
* Are unwilling to enroll your baby in the 12 month follow-up testing planned in this study.
* Are planning to move out of the area within the next 2 years or plan to be out of the study area for more than 1 month in the next year.
* Are unwilling to be assigned at random to any of the intervention groups.
* Are planning to terminate your pregnancy.
* Are planning to give your baby up for adoption.
* Are pregnant with a baby who has a known fetal anomaly.
* Have a reason that exercising is unsafe (determined by your physician or study staff).
* Have had or plan to have bariatric surgery within 1 year of your expected delivery.
* Currently have or have a history of the following:
* 3 or more first trimester miscarriages
* High blood pressure
* Type 1 diabetes
* Diagnosis of pregnancy related diabetes during screening
* HIV or AIDS
* Psychotic disorder, major depressive episode, bipolar disorder or eating disorder
* Any other pregnancy, blood, heart, lung, hormone, or digestive problem that your doctor considers unsafe for participation in this study
Socio-Economic Survey in Uganda

This study will be conducted at Mulago Teaching Hospital. Patients coming to the ER with an orthopaedic injury will be approached. If a patient consents to be part of the study, they will complete a questionnaire. Participation in the study will end as soon as the questionnaire is completed.

All patients will be recruited from the orthopedics inpatient wards and emergency department at Mulago National Referral Hospital. Only patients who have sustained an orthopedics injury will be included in this study, and the severity will be recorded for future references. No Protected Health Information (PHI) will be collected throughout the study.

Steps

1. Identify patients from Mulago Teaching Hospital
2. Enrollment of patients into survey study
3. Administer survey to patients at 1st meet up
4. Administer survey to doctor-in-charge?
5. Compilations of survey results into excel spreadsheet. Participants will be assigned an ID. The study team does not intend to collect any PHI.
6. Statistical Analysis.

Eligibility Criteria:
Inclusion criteria:

* Subject is a male or female 18 years old or older.
* all patients presented at Mulago National Referral Hospital with orthopedics trauma injuries regardless of age and gender.

Exclusion criteria:

- patients presented with all other conditions other than orthopedics related injuries that may require long term care. Some examples are head injuries leading to long term damage, loss of sights, etc.
A Study of TYRA-300 in Children With Achondroplasia: BEACH301

The purpose of this study is to evaluate the safety, tolerability, and identify potentially effective dose(s) of TYRA-300 in children with achondroplasia with open growth plates.

This is a Phase 2, multicenter, open-label, dose-escalation study to determine the safety, tolerability, and identify potentially effective dose(s) of TYRA-300, a fibroblast growth factor receptor (FGFR)-3 selective tyrosine kinase inhibitor, in children 3 to 10 years of age with achondroplasia with open growth plates that will examine three cohorts of children: the Sentinel Safety Cohort, Cohort 1, and Cohort 2.

Eligibility Criteria:
Inclusion Criteria:

* Aged 3 to 10 years old (inclusive) at the time of consent.
* Informed consent provided by parent(s) or legal guardian(s). As study participants are less than 18 years old, participants are willing and able to provide written assent (where applicable and required).
* Molecular diagnosis of achondroplasia (FGFR3 G380R).
* Radiographically confirmed open growth plates at Screening, as determined by bone age X-ray.
* Able to stand and ambulate independently.
* Able to take oral medication.
* Sentinel Safety Cohort only: aged 5 to 10 years old (inclusive).
* Cohort 1 only: aged 3 to 10 years old (inclusive) and are naive to prior growth accelerating therapy.
* Cohort 2 only: aged 3 to 10 years old (inclusive) and have received prior growth accelerating therapy.

Exclusion Criteria:

* Presence or history of any concurrent disease or condition that would interfere with study participation, safety evaluations, or any uncontrolled or untreated condition that could impact pediatric growth.
* Diagnosis of endocrine condition that alters calcium/phosphate homeostasis.
* Prior limb lengthening surgery or planned or expected to have limb lengthening surgery while enrolled in the study.
* Taking medications that are strong inhibitors or inducers of cytochrome P450 (Cyp) 3A4.
* History or current evidence of corneal or retinal disorder/keratopathy.
* Presence of guided growth hardware/8 plates. Planned or anticipated orthopedic surgeries.
Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms

Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.

Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS.

This is a single-centered, prospective, single blind, randomized controlled study of patients with MS who suffer lower urinary track symptoms. All patients will be informed of the details of all the procedures and of the details of the study. After the written informed consent is obtained, patients will be distributed to two equal groups using randomized number table.

At the beginning and end of the study, post-void residue (PVR) will be calculated with ultrasonography, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Quality of Life( I-QOL), 3 day bladder diary (number of urination, urge, incontinence, nocturia) forms will be administered.

Patients will be evaluated via PVR, urodynamic measurements, ICIQ-SF, I-QOL and bladder diary.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer Adults (Age 18-50)
* Diagnosis of Multiple Sclerosis
* Expanded Disability Status Scale (EDSS) 0-6,5
* Lower urinary track symptoms (Urinary incontinence, urgency, nocturia and/or urinary frequency)
* Diagnosis of bladder disfunction with Urodynamic study within 1 months

Exclusion Criteria:

* Age less then 18
* Pacemaker or implantable defibrillator usage
* Diabetic polyuria
* Bleeding diathesis or severe bleeding tendency
* Pelvic floor disfunction or nerve damage effecting tibial nerve
* Currently pregnant or planning pregnancy
* Active urinary infection
* Active malignancy
* Severe mental disability
* Cognitive deficit
* Expanded Disability Status Scale (EDSS) greater than or equal to 7
* Unable to attend to TPTNS treatment 2 times a week
* Urodynamic findings of bladder outlet obstruction
* Surgical history because of urinary incontinence
* Urologic surgical history because of lower urinary track disfunction or symptoms
* Diagnosis of prostatic enlargement
* Diagnosis of pelvic organ prolapse