cyrilzakka/clinical-trials huggingface dataset:
SWOG-8819 Collecting, Analyzing, and Storing Tissue Samples From Patients With Non-Hodgkin's Lymphoma

RATIONALE: Collecting and storing samples of tissue from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. It may also help doctors learn how patients respond to treatment.

PURPOSE: This laboratory study is collecting, analyzing, and storing tissue samples from patients with non-Hodgkin's lymphoma.

OBJECTIVES:

* Establish a central lymphoma tissue repository of fresh snap-frozen tissue from patients with previously untreated non-Hodgkin's lymphoma (NHL).
* Determine a standard set of procedures for routine acquisition, banking, and study of these tissue samples.
* Correlate presently activated phenotyping studies and future projected molecular studies of the DNA and RNA status of these tissue samples with clinical results.
* Correlate pretreatment phenotype or genotype of tissue samples from patients with intermediate- or high-grade NHL with patient outcome, in terms of complete response rate, time to progression, and survival.
* Correlate the lymphoma lineage (T-cell vs B-cell), loss of class II human histocompatibility antigen status (HLA-DR-positive vs HLA-DR-negative), proliferative index (as measured by Ki-67), and B- or T-cell antigen aberrancy (e.g., lack of Pan B or T antigen expression) with outcome in patients with intermediate- or high-grade NHL.

OUTLINE: Patients are treated on the SWOG study on which they are enrolled.

Tissue samples obtained before treatment began are banked in a tissue repository.

Samples from patients with intermediate- or high-grade non-Hodgkin's lymphoma are analyzed by three-stage immunohistochemistry using monoclonal antibodies to B-cell antigens, T-cell antigens, immunoglobulins, CALLA, HLA-DR, anti-interleukin-2 receptor, and Ki-67 (for the proliferative index). Phenotype (immune marker status, proliferation status, and activation status) is correlated with response to treatment, relapse, and overall survival.

PROJECTED ACCRUAL: Approximately 495 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Registered on an active Southwest Oncology Group (SWOG)-coordinated treatment protocol for previously untreated non-Hodgkin's lymphoma
* Adequate pretreatment diagnostic tissue available meeting the following requirements:

  * Fresh snap-frozen pretreatment diagnostic biopsy from any site (initial biopsy or rebiopsy)
  * 1 Hematoxylin and Eosin stained slide
  * 1 paraffin block and surgery pathology report

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
The Effect of tES on a Cognitive Training

The aim of this study is to investigate the effect of a transcranial electrical stimulation (tES) on a cognitive training in healthy elderly and memory impaired participants. In order to assess these effects different memory and attention tasks will be performed before and after the training as well as after 6 and 12 months.

As other studies have shown, transcranial direct current stimulation (tDCS) can improve the outcome of memory tasks in Alzheimer's disease (AD), mild cognitive impairment (MCI) and healthy older adults. Only few studies have investigated the effect of the combination of tDCS and a simultaneous cognitive training and to the investigators' knowledge there is no comparison of tDCS and transcranial alternating current (tACS) effects during a cognitive training or for different populations. With results from this study existing trainings can be optimised. In total 180 participants are planned to be included in this study. This number is based on a g\*Power estimation. According to this estimation the study has to include 153 participants. Regarding similar studies the investigators assume a dropout rate of 15% resulting in a total of 180 participants (60 AD patients, 60 MCI patients and 60 healthy older adults) This number should make it possible to find the expected mild effects reported in literature.

A mixed-effects ANOVA model with the between-subjects factor stimulation (tDCS, tACS, sham) and the within-subjects factor time will be computed.

Eligibility Criteria:
Inclusion Criteria:

* Able to give their consent to participate in the study
* Native or fluent German speaker
* Normal or corrected to normal vision and hearing
* Ability to visit the study location for 14 appointments

Exclusion Criteria:

* Acute neurological (other than memory impairment) or psychiatric disorders
* Seizures
* Magnetisable implants
* High dose of psychotropic drugs
* Drug or alcohol abuse
* Participation in another study with investigational drug
* tES in the 2 months preceding or during the present study
* Severe head injuries
* Skin disease
* Caffeine 3 hours prior to training
Benefits of Total Intravenous Anesthesia Compared With Inhaled Anesthesia in Cardiovascular Surgery

This study compares the difference in proinflammatory markers Interleukin 6 (IL-6), Tumor necrosis factor alpha (TNFα) and cortisol in patients undergoing cardiovascular surgery to asses if there is a benefit of using intravenous total anesthesia (TIVA) over inhaled anesthesia for this procedures.

IL-6, TNFα and cortisol will be measure at the beginning of the cardiovascular surgery and 20 minutes after the cardiovascular bypass ends to calculate the difference between them and compare if there is any statistical difference between the proinflammatory markers with the two anesthesia techniques.

Eligibility Criteria:
Inclusion Criteria:

Scheduled for cardiovascular surgery American Society of Anaesthesiologists (ASA) physical status classification II-IV BMI \< 25 HbA1c \< 7%

Exclusion Criteria:

Diabetic patients Known allergy to propofol
Endoscopic Resection of Non-ampullary Duodenal Adenomas: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Full-thickness Resection With the 'Duodenal Full-thickness Resection Device' (dFTRD)

Prospective, randomized multi-center trial. Comparison of Endoscopic Mucosal Resection (EMR) versus Endoscopic Full-Thickness Resection with the duodenal Full-Thickness Resection Device (dFTRD) of non-ampullary duodenal adenomas.

Prospective, randomized multi-center trial. Comparison of Endoscopic Mucosal Resection (EMR) versus Endoscopic Full-Thickness Resection with the duodenal Full-Thickness Resection Device (dFTRD) of non-ampullary duodenal adenomas.

Eligibility Criteria:
Inclusion Criteria:

* duodenal adenoma
* age 18 or older
* written informed consent

Exclusion Criteria:

* duodenal adenomas with a size \> 25 mm
* duodenal adenomas with 20 mm or less distance to the major and/or minor duodenal papilla
* presence of two or more duodenal adenomas
* suspected or histologically confirmed malignancy
* tumor disease (exception: after successful curative treatment)
* conditions/diseases of the upper GI-tract that impair advancing of the devices into the duodenum
* moribund patient
* pregnancy and breastfeeding
* patients that cannot give informed consent (e.g. psychiatric disorders, language barrier,...)
* other contraindications for duodenal resections
Noninvasive Dual-mode Stimulation Therapy for Neurorehabilitation in Stroke

Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both inhibitory rTMS (1Hz) and anodal tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single inhibitory rTMS stimulation in subacute stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* First-ever stroke patients
* Subacute stage (less than 4 weeks)
* Total Fugl-Meyer Assessment (FMA) score under 84

Exclusion Criteria:

* Major active neurological disease or psychiatric disease
* A history of seizure
* Metallic implants in their brain
Artificial Intelligence Assisted Socket Shield With Computer Guided Implant Placement

Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided immediate implant placement performed simultaneously with artificial intelligence assisted socket shield technique versus conventional approach.

Guided implant surgery was used in dental implant surgery to achieve accuracy and an overall predictability. Successful guided implant workflow depends on 3-dimensional image acquisition and precise model fabrication.

Artificial intelligence application in implant dentistry has ushered in a new era of precision and efficiency demonstrating improved implant survival rates and patient satisfaction and enhance the integration of technologies with digital workflows.

Eligibility Criteria:
Inclusion Criteria:

* above the age of 18years
* presence of non-restorable maxillary anterior tooth
* had intact socket walls following tooth extraction
* the gingival biotype was thick.

Exclusion Criteria:

* history of systemic condition
* history of using bisphosphonates or other drugs that might impact bone turnover
* a history of smoking during the previous five years,
* a history of any acute infections at the surgical site,
* teeth having root resorptions
The Effect of Musical Video With Virtual Reality Goggles on Patient's Anxiety and Comfort During Ureteroscopy

The effect of musical video with virtual reality goggles on patient's anxiety and comfort during ureteroscopy

Ureteroscopy is a surgical procedure used diagnostically or therapeutically in urology. Eliminating the patient's fear, anxiety and worry in the preoperative period is necessary to reduce the surgical stress response seen during the surgical procedure and to ensure normal physiological functions after surgery, early mobilization and patient comfort. When the patient is taken into surgery, reassuring and gentle communication should be established to reduce the patient's anxiety. For this reason, it is important that the surgical team members feel that they are with the patient and make the patient feel that they are with them.

Music is an art that organizes sounds in a way that provides a feeling of happiness. It can help the patient cope with all aspects of the disease; it improves physical, emotional, social and spiritual well-being and can help control and reduce pain and/or agitation. studies examining the relationship between music and depression and anxiety, it was found that depression and anxiety scores were significantly lower in the music therapy group compared to the control group.

The aim of this study was to examine the effect of virtual reality goggles and musical video playback on the patient's operating room anxiety and comfort during ureteroscopy.

The hypotheses that there is no difference in anxiety and comfort levels in the intervention and control groups after music intervention will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Being able to speak and understand Turkish
* Being open to communication
* Being literate
* Being over 18 years of age
* Having a Glasgow Coma Scale score of 13 and above

Exclusion Criteria:

* Visual and hearing impairment
* Previous surgery
* Being a healthcare personnel
* General anesthesia of the patient
Comparison of Concomitant Cisplatin Versus Carboplatin and 5-fluorouracil With Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

Concomitant chemoradiotherapy improves overall survival in patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) compared to radiotherapy alone. Cisplatin 100 mg/m2 at day 1, 22 and 43 is widely used but results in considerable acute and late toxicity. Three cycles of carboplatin plus 5-fluorouracil (5-FU) is an accepted alternative but both chemotherapy regimens have not been compared prospectively. The aim of this study is to compare tolerability, efficacy, toxicity and quality of life in patients with LA-HNSCC treated with concomitant cisplatin and carboplatin plus 5-FU.

This is a retrospective comparison of patients with LA-HNSCC treated with chemoradiotherapy at 2 tertiary care centers in the Netherlands (UMCG and VUmc), where one center routinely gives carboplatin plus 5FU (UMCG) and the other center (VUmc) uses high dose cisplatin as standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Stage III-IV LA-HNSCC of hypopharynx, oropharynx, larynx, oral cavity
* Primary treatment with concomitant chemoradiotherapy consisting of three-weekly cisplatin or carboplatin plus 5-FU
* Age ≤ 70 years
* No previous treatment for head and neck cancer
* No distant metastases

Exclusion Criteria:

* Previous treatment for head and neck cancer
* Distant metastases
Integrating Family Planning With Immunization to Improve Maternal and Child Health

The proposed project will help in assessing the effectiveness of a demand-side financing project that provides family planning services bundled in a package of postnatal care and infant immunization services. This approach will use postnatal and infant health as a gateway to family planning - building confidence among the client and her influencers in the provider and repositioning family planning as part of a continuum of care to ensure the health of the mother and the infant. Vouchers will help in creating demand among poor women for the Family planning and child immunization. Also incentivizing providers against each voucher will help in improving their counselling skills as they will spend more time with voucher clients resulting is a satisfied client and better compliance with Family planning methods.

Study hypothesis: Contraceptive Prevalence Rate will increase up to 20% from the baseline to end line survey in the intervention area .Contraceptive Prevalence Rate will increase by 5% between baseline and end line survey in the control area.

Ethics approval: The study has been approved by Population Services International Research Ethics Board.

Study design: This is a quasi experimental design. The study is a single center.

Primary study design: Interventional Trial setting: Community. Interventions: Introduction of vouchers will improve uptake of family method as well as child immunization.

Incentivizing the providers to improve their counseling skills will improve the provider client relationship and better compliance of Family planning method.

Intervention Type: Behavioral Primary outcome measures: Number of women who took up modern, reversible contraceptive methods ,number of women who availed postnatal care and number of women whose infants were immunized among the two poorest quintiles.

Secondary outcome measures: Improve the quality of family planning service provision in private sector health facilities serving low-income women.

Eligibility

Participant inclusion criteria - Participant type: Other. Participant inclusion criteria - Description: Women who are married in their reproductive age group i-e 15 to 49 years and who have given birth to a child within past one month.

Participant inclusion criteria - Target number of participants: 28000. Participant exclusion criteria: Women who are not married and are not in their reproductive age group i-e 15-49 years and who has not given birth within past 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Women who are married in their reproductive age group i-e 15 to 19 years and who have given birth to a child within past one month

Exclusion Criteria:

* Women who are not married and are not in their reproductive age group i-e 15-49 years and who has not given birth within past 1 month
A Study on the Outcomes of Recombinant Von Willebrand Factor on Demand Treatment and Prevention and Treatment of Bleeding During and After Surgery in Adults With Inherited Von Willebrand Disease in the United Kingdom (UK)

This study is a retrospective chart review study and will collect data on real world use of vonicog alfa (Recombinant Von Willebrand Factor \[rVWF\]). Von Willebrand disease (VWD) is the most common inherited bleeding disorder. rVWF is approved in Europe and UK to treat bleeding and to treat and prevent bleeding during surgeries in adults in 2018.

This study will review and collect information on the treatment and bleed prevention of adult persons with inherited VWD with rVWF in UK. These data were already collected as a part of the routine care.

The main aims of this study are to describe the use of rVWF in on-demand treatment of bleeding and the prevention of treatment and treatment of bleeding during surgeries. Other aims are to describe bleedings and their treatment as well as any surgeries before and after first treatment with rVWF and to gather information on the use of healthcare resources (such as hospital visits, emergency room visits, etc.).


Eligibility Criteria:
Inclusion criteria:

* Adults (aged 18 or over at time of first administration of rVWF) who have provided informed consent and used rVWF within its licensed indication.
* Participants who have been diagnosed with congenital von Willebrand disease.
* Confirmed instance of

  * at least one bleed (either a new bleed or ongoing bleed treated under a treatment switch) treated on-demand with rVWF between 01-Oct-2020 and 30-Jun- 2022 and/or
  * treatment to prevent and treat surgical bleeds with rVWF between 01-Oct-2020 and 30-Jun-2022

Exclusion criteria:

* Participants who were aged 17 years or less at the time of the first administration of rVWF.
* Participants who have been diagnosed with any other bleeding disorders or factor deficiencies including acquired von Willebrand disease.
* Participants with neutralising antibodies/inhibitors to VWF.
* Participants participation in a clinical trial of an investigational medical product during the study period.
Prognostic Impact of Cardiac Imaging During Suspected Immune Checkpoint Inhibitor Myocarditis

It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour.

Patient with a risk of preterm labor (ultrasound cervical length \< 25 mm +/- described or recorded uterine contractions) before 32 weeks of gestation will be hospitalized to receive tocolytic drugs and antenatal corticosteroid therapy according to the investigators gold standard protocol. After 48 hours, the participants will be assessed by examination, external tocodynamometry and the measure of cervical length by ultrasound. Stabilized patients will be included and randomized into 2 groups of 210 patients each. The first group "A" will benefit from the standard protocol (extended hospitalization of 2 or 4 days according to the clinical and ultrasound assessment); whereas the second group, "B", will have the benefit of the detection of phIGFBP-1.If the result proves negative, patients could be discharged early at day 2. In the case of a positive result, patients will follow the standard procedure because of the low positive predictive value of the test. The main outcome is the total duration of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

All patients affiliated to the French social security system will be eligible, after signing a consent form, and presenting the following criteria

* Introduction within the last 3 months of at least one of the following ICIs: nivolumab, pembrolizumab, cemiplimab, avelumab, atezolizumab, ipilimumab, tremelimumab, durvalumab.
* Suspicion of myocarditis defined by the presence of at least one of the following criteria adapted from the European Society of Cardiology guidelines:

  * Symptomatic patients (chest pain, dyspnea, palpitations, syncope/lipothymia) within 7 days of ICI administration
  * New ECG abnormality (ST-segment elevation, ST-segment undershift, arrhythmia, conductive disturbances, T-wave inversion)
  * Elevation of troponin above the 99th percentile of the laboratory reference value or, if troponin is already elevated before treatment, an increase of more than 30% of the baseline value
  * Recent LVEF decline or recent LV contraction abnormality on a TTE
* Patient has given no objection

Translated with www.DeepL.com/Translator (free version)

Exclusion Criteria:

* Age \<18 years
* Major under guardianship or curatorship
* Pregnant or breastfeeding women
* Patient not covered by a social security plan
* Hemodynamic or rhythmic instability
* Estimation of glomerular filtration rate by the MDRD formula \<30ml/min/1.73m2
* Implantable equipment that does not allow for cMRI
A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and has full legal capacity to volunteer
* Has read, fully understood and signed the information consent letter
* Currently wears or has previously worn soft contact lenses
* Has spectacle cylinder ≤1.00D in both eyes.
* Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
* Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
* Has clear corneas and no active ocular disease
* Is willing and able to follow product usage instructions and maintain the visit schedule.

Exclusion Criteria:

* Has never worn contact lenses before
* Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
* Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
* Has any known active ocular disease and/or infection
* Has a monovision correction
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
* Is aphakic
* Has undergone corneal refractive surgery
* Is pregnant or lactating, determined by self-report
Vitamin B12 Acceptance and Biomarker Response Study

In this study, biomarker response after supplementation with oral and intramuscular vitamin B12 will be compared in a randomized clinical trial. Electronic compliance monitoring will be used to control for non compliance as a possible confounder in oral treatment. Additionally subjective acceptance in terms of presumed preferences will be compared with oral vs. intramuscular supplementation of vitamin B12 in the view of the patient.


Eligibility Criteria:
Inclusion Criteria:

* General practitioner's prescription for Vitamin B12 deficiency testing
* Age\> 18 years
* Ability to give written informed consent
* Vitamin B12 serum concentrations \< 200pmol/l
* indication for vitamin B12 supplementation according to the General practitioners estimation

Exclusion Criteria:

* Patients with incorrect intake of vitamin preparations containing vitamin B12
* Patients with previously diagnosed dementia
* Patients with known hereditary transcobalamin transportation defects
* lack of written and/or oral understanding in German, French, Italian or English languages