cyrilzakka/clinical-trials huggingface dataset:
Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-Line Treatment of Metastatic Colorectal Cancer in Adult Participants With a KRAS or NRAS Mutation

The purpose of this study is to assess 2 different doses of onvansertib to select the lowest dose that is maximally effective, and to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of onvansertib in combination with FOLFIRI + bevacizumab or FOLFOX + bevacizumab in patients with KRAS or NRAS-mutated metastatic colorectal cancer (CRC) in the first-line setting.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic colorectal cancer.
* Documented KRAS or NRAS mutation.
* No previous systemic therapy in the metastatic setting.
* Participants must be willing to submit archival tissue or undergo fresh biopsy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Women of childbearing potential must use contraception or take measures to avoid pregnancy.
* Imaging computed tomography (CT) or magnetic resonance imaging (MRI) of chest/abdomen/pelvis and other scans as necessary to document all sites of disease performed within 28 days prior to the first dose of onvansertib.
* Must have acceptable organ function

Exclusion Criteria:

* Concomitant KRAS or NRAS and BRAF-V600 mutation or microsatellite instability high/deficient mismatch repair.
* Prior treatment with a VEGF inhibitor, including bevacizumab or biosimilars.
* Previous oxaliplatin treatment within 12 months prior to randomization, when arm open.
* Known dihydropyrimidine dehydrogenase (DPD) deficiency.
* Anticancer chemotherapy or biologic therapy administered within 28 days prior to the first dose of study drug.
* Untreated or symptomatic brain metastasis.
* Gastrointestinal (GI) disorder(s) that would significantly impede the absorption of an oral agent.
* Unable or unwilling to swallow study drug.
* Uncontrolled intercurrent illness.
* Known hypersensitivity to fluoropyrimidine or leucovorin, irinotecan, or oxalipatin.
* Abnormal glucuronidation of bilirubin; known Gilbert's syndrome.
* Use of strong CYP3A4 or CYP2C19 inhibitors or strong CYP3A4 inducers.
* QTc \>470
E-Support Groups in Multiple Sclerosis

Primary objectives:

* To determine the feasibility of program (80% retained with 75% overall attendance, and completed immediate follow-up questionnaires from 75% of participants).
* To determine the efficacy of program (evaluated by decreased loneliness, operationalized as decreased total score on the UCLA Loneliness Scale from pre to post intervention).

Secondary objective:

* To determine whether program will affect depression and quality of life.

This study involves prospective data collection from an intervention to investigate the impact of participation by MS patients in a 12-week guided online social support group. All outcomes will be compared to active control group. At the completion of a 12-week interval, all participants (placebo and treatment) will complete follow-up questionnaires. Three months after completing, participants will be sent follow-up questionnaires that will be evaluated as a 6-month follow-up, to assess retention of benefits.

Social support has been linked to better health outcomes in many clinical populations. Multiple sclerosis (MS), a chronic neurological disease that affects over 400,000 people in the United States, involves physical and cognitive disability that can have negative consequences on social integration. This can lead to social isolation, which may be dynamically related to depression, fatigue, and disease progression. The aim of the present study is to investigate the impact of support group involvement on persons with MS. Outcomes of interest include mood, loneliness, and quality of life (QOL). Many people with MS feel isolated and are unable to participate in support groups that meet in locations that may be far from home, difficult to travel to (due to physical disability or lack of resources), or may not be convenient for their schedules. Another hindrance is the apprehension that MS patients sometimes experience when they encounter patients with severe physical disability, or worse impairment than their own. For these reasons, the study is introducing remote support groups to be conducted via the internet, "e-Support." Attending a remote, internet based support group may be more appealing to patients with MS as it obviates the need to travel, thereby reducing cost, time, and energy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS (any disease type)
* Age 18 or over
* Willingness to sign informed consent document

Exclusion Criteria:

* Unable to obtain access to the internet
Sodium Glucose Co-Transporter 2 (SGLT2) and STEMI

The purpose of the research is to determine whether a class of medication called SGLT2 inhibitor will improve the heart's function and reduce its enlargement after a heart attack. Participation in this study will involve taking this class of medication (or a placebo) once daily for six months, one cardiac magnetic resonance imaging (MRI) test during your initial hospitalization, follow-up phone calls at 1 and 3 months, and one cardiac MRI and clinic visit at six months. This is a single center study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with their first STEMI (\>18 years) who underwent successful primary PCI and able to give informed consent
* At least mild LV dysfunction (LVEF \< 50%) on echocardiogram, cMRI or Left Ventriculargram following PCI
* Infarct size that is \> 10% of LV mass
* The presence of MVO that is \> 10% of infarct size

Exclusion Criteria:

* Contraindication to cardiac MRI
* Life expectancy \< 1 year
* Previous CABG or Valve Surgery
* Previous STEMI
* Pregnant or planning to become pregnant or lactating women
* Cardiogenic shock (not resolved)
* Atrial fibrillation or recurrent sustained ventricular arrhythmias (excluding PVCs)
* GFR\<30 ml/min/1.73m2 or end-stage renal disease on dialysis
* Type 1 diabetes mellitus or history of diabetic ketoacidosis
* Type I or II diabetes with insulin use
* Prior intolerance of SGLT2 inhibitors
* Current use of SGLT2 inhibitors (randomized patients only)
* Contraindications to gadolinium
Maintenance Therapy of 308-nm Excimer Laser Therapy in Patients With Vitiligo

Although vitiligo is difficult to cure, recurrences are frequent after treatment, and many patients suffer from concerns about recurrence as well as disease. Psoriasis, another indication for ultraviolet radiation treatment, has been established that it can safely and effectively reduce the recurrence of psoriasis through monthly maintenance therapy. The aim of this study was to evaluate the efficacy of 308-nm excimer laser therapy for the prevention of relapse in vitiligo.

For a total period of 12 months, perform the 308-nm excimer laser treatment once a month. Check for signs of enlarged vitiligo lesions at 3-month intervals for a total period of 12 months.

An independent evaluator will obtain the score of vitiligo area (Vitiligo Extent Score) from comparing clinical photographs of before registration and after the clinical trial, and judge whether vitiligo is recurred. This study is a randomized controlled trial, and the investigators plan to compare the recurrence rates of the experimental and control groups using the Chi-squared test.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with age of 19 years or older
2. Patients of generalized vitiligo with lesions on the trunk
3. Patients who had treated with the 308-nm excimer laser previously and achieved more than 75% lesion improvement
4. Patients who voluntarily agreed to participate in the study

Exclusion Criteria:

1. Patients under the age of 19
2. Patients with localized vitiligo and segmental vitiligo
3. Patients who are in a state of physical or mental impairment to perform treatment or pregnant
4. Patients with spreading of vitiligo lesions
5. Patients who do not want to do thie study or who refuse to write a consent form
6. Any other person deemed unsuitable for the examination at the discretion of the examiner
Long-term Survival Outcomes According to the Pathologic Response After Neoadjuvant Treatment in PDAC and the Fate of the Patients with Good CAP Grade

1. Neoadjuvant treatment (NAT) is increasingly used in managing pancreatic ductal adenocarcinoma (PDAC), necessitating dependable methods to evaluate tumor response.
2. Among various pathological tumor regression grading systems, the College of American Pathologists (CAP) system is commonly used to predict chemo-responsiveness and survival.
3. This study aimed to analyze long-term survival outcomes based on pathologic response using the CAP grade after NAT in PDAC and to identify clinicopathologic factors that influence a favorable pathologic response.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged \&gt;18 years) who underwent pancreatic resection after NAT at a single center between January 2009 and December 2023.
* Patients were initiated on NAT after confirming PDAC diagnosis based on pathological examination.

Exclusion Criteria:

* Patients without a reported CAP grade
* Patients who underwent palliative surgery
* Patients who received NAT outside the specified protocol due to incomplete information.
Peri-implantitis Implantoplasty Treatment

This double arm, split-mouth, single centre, controlled, randomised clinical study is designed to examine the effect of implantoplasty in treatment of peri-implantitis.

Peri-implantitis will be treated with open flap debridement, with or without implantoplasty.


Eligibility Criteria:
Inclusion Criteria:

* Peri-implantitis (according to 2018 criteria) on minimum 2 implants of similar surface and defect type
* Competent to give consent
* Exposed, modified implant surface with loss \>2mm

Exclusion Criteria:

* Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
* Present or past use of bisphosphonate treatment • Pregnant or nursing subjects
* Patients classified as \> class II according to ASA classification
* Implant unavailable for implantoplasty treatment
* Inhability to comprehend and respond to the quality of life questionnaire
* Examiners/operators deem original placement of implant (angle, position) suboptimal and considered to play a major role in development of peri-implantitis
* History of peri-implantitis surgery prior to 6 months of screening
Laboratory Study of Lymphoblasts in Young Patients With High-Risk Acute Lymphoblastic Leukemia

RATIONALE: Collecting and storing samples of bone marrow and blood 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.

PURPOSE: This laboratory study is looking at lymphoblasts in young patients with high-risk acute lymphoblastic leukemia.

OBJECTIVES:

* Identify regions of copy number abnormalities (CNA) and uniparental disomy in leukemic lymphoblasts from pediatric patients with high-risk acute lymphoblastic leukemia (ALL) using Affymetrix GeneChip Mapping 500K array sets. (Pilot project)
* Identify regions of CNA and loss-of-heterozygosity using Affymetrix SNP 6.0 microarrays. (Expansion project)
* Define gene expression profiles for leukemic lymphoblasts using Affymetrix U133 Plus 2.0 arrays.
* Assess the global expression of microRNAs in leukemic lymphoblasts using microRNA gene chips.
* Utilize array-generated gene expression data and data for CNAs and uniparental disomy to prioritize candidate genes and genomic regions for resequencing.
* Characterize epigenomic profiles using the HpaII tiny fragment Enrichment by Ligation-mediated PCR (HELP) assay. (Expansion project)
* Discover candidate therapeutic targets for these patients by identifying genes that are consistently mutated in leukemic lymphoblasts using high-throughput focused gene resequencing. (Pilot project)
* Discover candidate therapeutic targets for these patients by next generation sequencing technologies, including whole genome, whole transcriptome, and whole exome. (Expansion project)

OUTLINE: This is a multicenter study.

Banked biological samples (bone marrow and peripheral blood) are analyzed using gene expression profiling, single-nucleotide polymorphism and genotyping assays, DNA copy number and loss of heterozygosity estimates, epigenetic profiling, and gene resequencing.

PROJECTED ACCRUAL: A total of 150 patient samples will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL)

  * High-risk disease
* Participation in clinical trial COG-P9906 required (pilot project)

  * In complete remission
  * Consented to future studies using banked tissue specimens
* Participation in clinical trial and COG-AALL03B1 and linked therapeutic studies COG-AALL0232 and COG- AALL0331(expansion project)

  * Experienced a bone marrow relapse within 36 months of initial diagnosis
  * Consented to future studies using banked tissue specimens
  * Have matched ALL blast and germline specimens
  * Demographic, clinical and pathologic data elements for these biospecimens available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Evaluation of a Fracture Liaison Service in the Osteoporosis Care

The St JOSEPH'S HOSPITAL set up a fracture liaison service for osteopotic fracture. A specific nurse screens eligible patient admitted in emergency yard and call them to propose a bone densitometry and a medical coverage..

The aim of the study is to evaluate this new organisation


Eligibility Criteria:
Inclusion Criteria:

* Age between 45 and 95 years old.
* Admitted in emergency yard for law energy trauma

Exclusion Criteria:

* feet fracture
* fracture on prothesis
* patient transferred elsewhere
* homeless people
* patient with lot of comorbidities
Kidney Fibrosis and MRI

The investigators plan a prospective cross-sectional study of pediatric and adult healthy volunteers and patients with chronic kidney disease that will correlate a variety of quantitative MRI biomarkers with severity of renal insufficiency and available histopathology. Over 3 years, the investigators will recruit approximately 20 healthy volunteers, 20 patients with chronic kidney disease (CKD) Stage 2-5, and 20 patients with renal transplant kidneys. The investigators also plan to assess the effect of inflammation on the quantitative MRI biomarkers by recruiting approximately 20 additional patients with active lupus nephritis.


Eligibility Criteria:
Inclusion Criteria:

Subjects who meet all of the following criteria will be eligible for the study:

1. ≥ 10 and ≤ 25 years of age and;
2. Kidney transplant patients, who have had a recent kidney biopsy (within 1 year) that shows interstitial fibrosis OR
3. Patients with CKD Stage 2-5 who have previously had a biopsy (within 1 year) OR
4. Lupus patients with active nephritis who will undergo biopsy evaluation before and after induction therapy OR
5. Healthy Controls

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

1. Known contraindication to MR imaging (e.g., implanted non-MRI compatible device)
2. Known or suspected pregnancy. Female subjects of child bearing potential will undergo a urine pregnancy test prior to imaging.
3. Inability to undergo MRI without sedation/anesthesia.
4. Non-English Speaking
Treating Tobacco Dependence in Adolescents With Co-occurring Psychiatric Disorders

This research aims to identify efficacious strategies for treating tobacco dependence among adolescent smokers with co-occurring psychiatric disorders. Adolescent smoking remains a significant public health issue with 23% of high school students reporting smoking a cigarette in the past month1. Smoking rates are two to four times higher among adolescents with psychiatric disorders such as attention deficit disorders, conduct disorder, depression, anxiety disorders, and alcohol and illicit drug dependencies2-4.

Empirical investigations of adolescent tobacco treatment interventions number less than 50 with many of the studies criticized for methodological problems (i.e., follow up \< 6 months, poor retention, lack of control or comparison groups)2,5, 6. There have been no unequivocal successes; however, promising interventions include stage-based, cognitive behavioral (CBT), and multicomponent treatments2, 7. Additionally, the nicotine patch is well tolerated and safe among adolescents8 and rarely abused9. Less than a third of adolescent tobacco users report intention to quit in the near future2, 10, 11; thus, it seems critical that cessation interventions for this complex group be designed to assist smokers at all stages of readiness through the quitting process. A stepped care approach has the potential of matching more intensive services to those ready for and in need of greater treatment. Interventions delivered in health care settings have the appeal of broad reach.

The primary specific aims of this research are to evaluate, in a randomized clinical trial (N=160), the efficacy of a stepped care intervention for treating smoking among adolescents recruited from outpatient psychiatry settings. To our knowledge, this would be the first study to examine outpatient psychiatry settings for treating tobacco dependence in adolescents. The stepped care intervention combines expert-system contacts, individual CBT sessions, and 12-weeks of nicotine replacement therapy (NRT).


Eligibility Criteria:
Inclusion Criteria:

* receiving active outpatient psychiatric care
* report smoking at least 1 cigarette in the previous 30 days and at least 100 cigarettes in their lifetime
* Other inclusion criteria are: no plan to relocate outside of the greater San Francisco Bay Area in the next 12 months and telephone access for scheduling follow up assessments.

Exclusion Criteria:

* cognitive impairment precluding ability to participate
* non-English speaking
* currently engaged in tobacco treatment
* Recruitment of acutely psychotic, manic, or hostile patients will be delayed until there is significant reduction of these symptoms and patients are able to assent to study participation
Opioid Versus Non-opioid Anesthesia for Ambulatory Surgery in Children

The investigators intend to study the safety and effectiveness of opioid free anesthesia compared to opioid anesthesia in ambulatory surgery in children, regarding postoperative pain, hemodynamic stability, agitation and discharge times. Quality of postanesthetic care was estimated in a 24h follow up.


Eligibility Criteria:
Inclusion Criteria:

* children,
* American Society Anesthesia I, II,
* ambulatory surgery

Exclusion Criteria:

* Allergy to anesthetic and analgesic drugs,
* history of neuromuscular,
* renal, neurological, hepatic disease,
* craniofacial anomalies,
* Obstructive Sleep Apnea,
* obesity,
* cardiopulmonary diseases
Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer

This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.

This is a randomized, controlled, open-label, parallel, multicenter study. Patients are stratified according to 3 factors ; performance status (ECOG scale: 0, 1, 2), disease stage (unresectable gastric cancer or recurrent gastric cancer (received prior adjuvant chemotherapy or not)) and participating center. Patients are randomized to one of two treatment arms. Arm A: Patients receive oral TS-1 twice daily on days 1-28 followed by 14 days rest. Treatment is repeated every 42 days for up to 4 courses. Arm B: Patients receive CDDP iv on day 8 and oral TS-1 twice daily on days 1-21 followed by 14 days rest. Treatment is repeated every 35 days for up to 5 courses. Patients are followed every 6 months for up to 2 years from the day they participates in this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma
* Unresectable and recurrent gastric cancer
* Age 20 to 74
* Performance status 0, 1, or 2 (ECOG)
* Life expectancy 3 months
* No prior chemotherapy or radiotherapy for gastric cancer
* Able to take oral medication
* Evaluable or not evaluable lesion had already checked more than 28 days before participated in this study
* Hematopoietic Absolute granulocyte count lower limit of normal-12,000/mm\^3 Platelet ≥ 100,000/mm\^3 Hemoglobin ≥ 8.0 g/dL
* Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
* Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 50 mL/min

Exclusion Criteria:

* Pregnant or nursing
* Bleeding from gastrointestinal tract or no diarrhea
* Hypersensitivity to TS-1 or CDDP
* Psychiatric disorder that would preclude study compliance or giving informed consent
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality
* Serious illness or medical condition
* Brain metastasis
* Ascites requiring drainage
PARAGON Platform for Outcome, Quality of Life, and Translational Research on Pancreatic Cancer

Due to the generally poor prognosis, with no chance of long-term survival, health related quality of life is a very important objective in the treatment of patients with pancreatic cancer. The non-interventional, prospective, multicentre PARAGON study is desinged to evaluate the health-related quality of life in patients with metastatic pancreatic cancer, by analyzing the course of QoL throughout all applied therapy lines for patients with pancreatic adenocarcinoma, measured according to EORTC scoring manual and patient reported outcome.

Pancreatic cancer is often diagnosed at an advanced stage, because most of the patients have no symptoms until the cancer metastasized. In the majority of study cases pancreatic cancer research focuses on therapy outcomes and prognosis. With poor prognosis and no chance of long-term survival, quality of life becomes a very significant purpose of pancreatic cancer care.

The PARAGON study is designed to see a bigger picture by acquiring data on quality of life (QoL) and further outcome of patients with localized, locally advanced and metastatic pancreatic cancer and moreover to establish a sample collection for future biomarker analysis.

The multicenter, prospective, permanent, register study PARAGON collects outcome data, patient reported outcomes (PRO), and tumor tissues of pancreatic cancer patients of both sexes and ages over 18 at approx. 80 German study sites. Patients diagnosed with pancreatic adenocarcinoma planned for (or recently started with) neoadjuvant, adjuvant or 1st line therapy can be included into the study.

The data assessment includes data on demography, basic parameters, anamnesis, comorbidities, therapies, outcome and survival data as well as patient reported outcome in QoL at baseline and every 8 weeks.

PARAGON's first objective is to determine the course of QoL throughout all applied therapy lines for patients with pancreatic adenocarcinoma, measured according to EORTC scoring manual and patient reported outcome. Secondary outcome measurements are e.g. progression-free, disease-free and overall survival according to treatment line.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent and signed data protection form before any study specific intervention, including screening, will be done
* Age ≥ 18 years
* Histologically or cytologically confirmed pancreatic adenocarcinoma
* Systemic neoadjuvant, adjuvant, 1st line systemic therapy is planned or recently started (within last 14 days)

Exclusion Criteria:

* Patients who are unable to consent because they do not understand the nature, significance and implications of the study
* Patients who are unable to understand or fill out the QoL survey
* Patients in 2nd or further treatment lines that have not been documented for 1st line therapy within the study