cyrilzakka/clinical-trials huggingface dataset:
Side Population in Pancreatic Ductal Adenocarcinoma (PDAC)

In the current project we aim to study the oncological process of pancreatic cancer, from a perspective of the CSC-theory and in particular through the 'side population' (SP)-approach. The SP seems to be enriched for CSC and doesn't a priori exclude any CSC-subpopulation. After isolation from pancreatic cancer resection specimens, SP cells will be characterized by gene-expression profiling based on microarray analysis. We'll identify markers and pathways (with emphasis for stem cell and cancer -related ones) that are differentially expressed in SP versus the rest of tumour cells (the 'main population' or MP). In order to assess the prognostic relevance of the SP, we'll study these genes using the high-throughput Nanostring technology in about 200 snap-frozen PDAC resection specimens of patients from our prospective database. Finally, two monoclonal antibodies (mAB) will be tested as novel therapeutic agents in vivo (mouse model), wherein the choice of mAB will be based on prognostically relevant molecular targets and pathways obtained from the Nanostring results.


Eligibility Criteria:
Inclusion Criteria:

* Resected pancreatic ductal adenocarcinoma (PDAC)
* Informed consent

Exclusion Criteria:

* Age \< 18years
* Pregnancy
* Pre-operative radiotherapy
* Pre-operative chemotherapy
* IPMT
Assessment of Dimensional Changes Following Grafting With Microfragmented Adipose Tissue Loaded on Allograft on Ridge Preservation

Evaluation of maxillary alveolar ridge changes (bone quantity and quality as revealed by radiographic and Histomorphometry ) utilizing microfragmented adipose tissue loaded on allograft versus allograft only for maxillary posterior ridge preservation

All patients involved in this study will be divided into two groups; each group will receive a different graft of bone augmentation: Adipose tissue loaded on allograft will be utilized for the study group and allograft only for the control group.

After 3-6 months, assessment of dimensional changes ( RG height \& width) on CBCT is performed and Histomorphometry will be evaluated via core biopsy at the time of implant placement in both groups.

Radiographic assessment that will be achieved by CBCT scan will be used to calculate the changes of bone height and width from base line (1week) to 3-6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring implant treatment after tooth extraction due to either unrestorable caries lesions or affected periodontium.

Age group: above 18 years

• Remaining natural teeth have good periodontal tissue support and occlusion showed sufficient inter arch space for future prosthesis.

Exclusion Criteria:

* • General contraindications to implant surgery.

  * Subjected to irradiation in the head and neck area less than 1 year before implantation.
  * Poor oral hygiene and motivation.
  * Severe bruxism or clenching.
  * Systemic, immunologic or debilitating diseases that could affect normal bone healing \& local pathosis.
  * Treated or under treatment of intravenous amino-bisphosphonates.
  * Active infection or severe inflammation in the area intended for implant placement.
  * Patients participating in other studies, if the present protocol could not be properly followed.
  * Heavy somkers
Efficacy of Lifestyle Intervention in BRCA1/2 Mutation Carriers

The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.

BRCA1/2 mutation carriers have a considerably increased risk to develop breast and ovarian cancer during their lifetime. There is evidence from the literature that for sporadic breast cancer disease risk and the course of disease can be significantly influenced by physical activity, nutrition and weight. The hypothesis of this 3 year, prospective randomized multicenter efficacy trial is that a structured life-style intervention program with exercise training and mediterranean diet is effective regarding increased adherence to a mediterranean diet, reduction of body mass index, and increase of physical fitness.

Eligibility Criteria:
Inclusion Criteria:

* proven pathogenic BRCA1/2 mutation
* age \>=18
* written informed consent

Exclusion Criteria:

* current chemotherapy of radiotherapy (inclusion 6 weeks after CTX or RX possible)
* metastatic tumor disease
* life expectancy \<3 years
* clinically limiting cardiovascular or respiratory disease (instable CVD, heart failure stage IV, COPD GOLD IV, maximum resting blood pressure 160/100 mmHg)
* significant orthopedic disability which prevents from participating in the group interventions
* severe concomitant diseases which prevents from participating in the group interventions
* Karnofsky index \<60
* maximum exercise capacity \<50 W
* food allergies which prevent from mediterranean diet
* vegan diet
* body mass index \<15 kg/m2
* pregnancy
* insufficient knowledge of German language
* insufficient compliance
* active participation in other interventional trials
Molecular Profiling in Prostate Cancer

We aim to employ targeted DNA NGS to evaluate the prevalence of germline and somatic mutations in cancer predisposing genes, such as BRCA1 and BRCA2, and other HR and DDR genes, including also a few additional clinically relevant genes, in patients with metastatic, locally advanced or high-grade prostate cancer. In addition, we will investigate the prognostic role of these mutations as well as their association with various clinicopathological parameters. This will be the first study investigating the prevalence of germline and somatic pathogenic mutations in Greek patients with prostate cancer.

This study will include formalin-fixed paraffin-embedded tumor tissue (FFPE) from 250 patients with metastatic, recurrent, locally advanced or "intermediate or high risk" (Gleason \>7), operable prostate cancer. FFPE tumor blocks alongside peripheral blood will be retrieved for all patients from Pathology Laboratories. Available FFPE blocks will be subjected to histological review by an experienced pathologist to evaluate H\&E sections for confirmation of diagnosis, histologic type, grade and tumor cell content (TCC%), as well as mark tumor dense areas for manual macro-dissection, prior to DNA extraction, in order to enrich samples for tumor DNA. Clinicopathologic characteristics of patients with prostate cancer will be retrieved from their respective medical records. Diagnosis will be confirmed through pathology reports, which will also provide information about Gleason Score and histological subtype.

In all instances, the collection of patient information will be in compliance with the regulations of the Bioethics committees of participating Hospitals. The study will be conducted in accordance with the principles of the Helsinki Declaration of Human Rights.

Following manual macro-dissection, FFPE tumor tissue material will be processed for DNA extraction, according to standard procedures with the QIAamp DNA Mini Kit (Qiagen GmbH, Hilden, Germany).

Sequencing will be performed at the Laboratory of Molecular Oncology, using an Ion Torrent Proton Sequencer (Life Technologies/Ion Torrent). For the purpose of targeted NGS genotyping of tumor and available matched germline DNA samples, we designed a custom Ampliseq panel to target coding relevant regions of genes involved in homologous recombination (HR), along with several others.

Data retrieval and base calling will be performed on the Torrent Server (v5.8.0.8). Consequently, we will then employ appropriate Ion Reporter Workflows (version 5.10) to automatically annotate single nucleotide variants (SNVs), multiple nucleotide variants (MNVs), small insertions / deletions (INDELs) and copy number variations (CNVs).

Eligibility Criteria:
Inclusion Criteria:

* metastatic prostate cancer
* recurrent prostate cancer
* locally advanced prostate cancer
* "intermediate or high risk" (Gleason \>7), operable prostate cancer
* available FFPE tumor tissue

Exclusion Criteria:

* absence of tumor tissue available for analysis
A Study Comparing PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy

The purpose of this study to to see how well Miralax (PEG-3350) and Gatorade cleans the colon before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel preparation solution. Another purpose is to see if taking half of the bowel preparation solution on the evening before the colonoscopy and half on the morning of the colonoscopy will result in a cleaner colon than taking all of the bowel preparation solution on the evening before.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 years in age
* Undergoing full colonoscopy for colorectal cancer screening or colon polyp/cancer surveillance or other diagnostic purpose

Exclusion Criteria:

* Allergic to polyethylene glycol
* Pregnant or lactating
* Baseline abnormalities of relevant serum electrolytes including Sodium, Potassium, Calcium, Magnesium and phosphorus
* Congestive Heart Failure NY Heart Assn, Grades III and IV
* Liver Cirrhosis Childs Pugh Class B or C
* Serum Creatinine greater than 1.5
* Previous alimentary tract surgery
* Ongoing symptoms of abdominal pain, bloating, nausea or constipation
* Ileus, suspected bowel obstruction, toxic colitis or megacolon, severe ulcerative colitis
Meditation and Emotional Intelligence

This randomized controlled trial evaluated the impact of the Transcendental Meditation program on emotional intelligence and perceived stress in supervisors and administrative staff in a public school system

The objective of this study was to determine whether a mind-body technique, known as the practice of Transcendental Meditation® (TM), could significantly increase emotional intelligence and decrease perceived stress in supervisors and administrative staff in a public school system. For this purpose, 96 participants from the administrative offices of the San Francisco Unified School District were randomly assigned to either immediate start of the TM program or to a delayed start wait-list control group. Subjects learning TM were instructed to meditate for 20 minutes twice a day for the four month duration of the project. All subjects were administered the BarOn Emotional Quotient Inventory (EQ-i) and Perceived Stress Scale (PSS) at baseline and posttest. If successful, these findings would suggest that TM could be used as a professional development program in organizations to increase emotional intelligence and decrease perceived stress, in turn enhancing leadership capacity and organizational effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* an employee of the San Francisco Unified School District (SFUSD),
* attendance at an informational meeting on the TM program,
* willingness to be randomly assigned to either active treatment or the control group.

Exclusion Criteria:

* having already learned the TM program,
* not being available to attend treatment or testing sessions.
A Single-dose Study Evaluating Romosozumab (AMG 785) in Healthy Postmenopausal Japanese and Non-Japanese Women

The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.


Eligibility Criteria:
Inclusion Criteria:

* Japanese subjects must be first (4 grandparents, biologic parents and subject born in Japan), second (4 grandparents and biological parents born in Japan) or third (4 grandparents born in Japan) generation Japanese
* Body mass index ≤ 25 kg/m², inclusive at screening
* Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result \> 40 mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in medical history (verified with an operative note, if available)

Exclusion Criteria:

* Osteoporosis, as defined by bone mineral density (BMD) T-scores of the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ -2.5
* History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis;
* Diagnosed with any condition that will affect bone metabolism
Study Evaluating the Efficacy and Safety of Flexible-dose Vardenafil in Subjects With Erectile Dysfunction

Study to investigate the efficacy and safety of Vardenafil


Eligibility Criteria:
Inclusion Criteria:

* Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
* History of unresponsiveness to sildenafil
* Stable sexual relationship for \> 6 month.

Exclusion Criteria:

* Primary hypoactive sexual desire
* History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
* Nitrate therapy
* Other exclusion criteria apply according to the US Product Information
Steroids in Fulminant Hepatitis A in the Pediatric Age Group

Fulminant hepatic failure (FHF) in children is a potentially devastating disease. The mortality rate may reach 80-90% in the absence of liver transplantation. Liver injury is considered to be mainly immune mediated with augmentation of cytolytic pathways of infected hepatocytes. For that, it is suggested that corticosteroids modulate the activity of the disease by suppressing the immune system.

Fulminant hepatic failure (FHF) in children is a potentially devastating disease. The mortality rate may reach 80-90% in the absence of liver transplantation. FHF is the clinical manifestation of liver cell death of a critical degree with insufficient hepatocellular regeneration and characterized by coagulopathy with or without hepatic encephalopathy.

Liver injury is considered to be mainly immune mediated with augmentation of cytolytic pathways of infected hepatocytes. For that, it was suggested that corticosteroids modulate the activity of the disease by suppressing the immune system.

Eligibility Criteria:
Inclusion Criteria:

The patient is diagnosed to have FHF, if he fulfilled all the following criteria:

1. Evidence of liver dysfunction within 8 weeks of onset of symptoms (neonates may have only deranged liver functions without overt symptoms).
2. Uncorrectable coagulopathy (6-8 hours after administration of one dose of parenteral vitamin K) with International Normalized Ratio (INR) \>1.5 in patients with hepatic encephalopathy, or INR\> 2.0 in patients without encephalopathy.
3. No evidence of chronic liver disease.

Exclusion Criteria:

1. Presence of absolute contra-indications to steroid therapy (as presence of an active gastrointestinal bleeding, renal failure, acute pancreatitis, active tuberculosis, uncontrolled diabetes and psychosis).
Baduanjin Exercise for Patients With Chronic Heart Failure on Phase II Cardiac Rehabilitation

Chronic heart failure (CHF) is the end stage of various kinds of cardiovascular diseases with high mortality. After a long period of medical treatment or surgical treatment, patients suffered great pain physically and mentally. How to improve the quality of life and prognosis in patients with CHF, which is a hot topic in the field of cardiac rehabilitation now. Baduanjin, as one of the traditional Chinese qigong exercises, has the features of generous stretch, soft consistency, dynamic but static, which is an appropriate movement pattern for CHF patients.

To investigate the efficacy and safety of Baduanjin exercise for patients with coronary heart disease complicated with chronic heart failure (CHF). A randomized, controlled and prospective clinical trial was designed.


Eligibility Criteria:
Inclusion Criteria:

* Aged from 40 to 75 years;
* Diagnosed with chronic heart failure caused by coronary heart disease;
* NYHA class I or II;
* Patients with an ejection fraction (LVEF) more than 40%;
* Participants in accordance with the guidelines define as stage II cardiac rehabilitation;
* Participants signed the informed consent freely and voluntarily.

Exclusion Criteria:

* The condition was serious or movement restrained by other diseases;
* In the acute stage of chronic heart failure;
* Participants with poorly control of blood pressure (SBP≥180mmHg or DBP≥100mmHg);
* Resting heart rate is beating over 120 beats a minute, or merged with malignant arrhythmia;
* Participants who have contraindications to cardiopulmonary test or exercise training;
* Patients who have other serious acute， chronic organic disease or mental disorders;
* Participants practiced in any kinds of traditional Chinese medicine exercises in last three months.
Chart Review: Drug Utilization Study in Participants Who Received Ozurdex™ (Dexamethasone Intravitreal Implant) 0.7 mg Injections for Visual Impairment Due to Diabetic Macular Edema (DME)

A retrospective, non-interventional, observational, multi-center, drug utilization study to be conducted in adult participants with visual impairment due to DME treated with Ozurdex implants in Germany and Switzerland from 1 January 2015 to 1 September 2017.


Eligibility Criteria:
Inclusion Criteria:

* Participant received at least two Ozurdex® implants in the study eye to treat visual impairment due to DME
* First Ozurdex® implant injection occurred after 1 January 2015
* Participant was followed-up at the site for at least 12 months after the first Ozurdex® implant in the study eye

Exclusion Criteria:

- Participant received Ozurdex® implants as part or during a clinical study
Role of Neutralizing Antibodies in the Prediction and Treatment of BK Virus Infection in Hematopoietic Stem Cell Allograft Patients at the Pediatric Oncology-hematology Department of the HUS

The BK virus (BKV) belongs to the Polyomaviridae family. The primary infection, generally asymptomatic, occurs during childhood. The virus then persists in latent form in the body, mainly in the epithelial cells of the kidney and urinary tract. Cellular immunosuppression favors BKV replication. It is responsible for pathologies of the renal-urinary tract such as BKV-associated nephropathy (BKVAN) in kidney transplant recipients, hemorrhagic cystitis (HC) in hematopoietic stem cell (HSC) recipients or ureteral stenosis.

To date, there is no specific antiviral treatment against BKV. The management of patients is essentially symptomatic and requires a multidisciplinary approach. It is therefore necessary to identify early prognostic markers for the occurrence of CH and to develop new therapeutic strategies.


Eligibility Criteria:
Inclusion criteria:

* Adult patient aged 18 to 19 years
* Minor patient (from birth to 17 years old)
* HSC allograft patient managed by the pediatric oncology-hematology service of the HUS, between 01/01/2015 and 31/12/2019

Exclusion Criteria:

* Opposition of the patient (or parental authority holders) to participate in the study
* Biological resources from a patient who does not meet all inclusion criteria
* Patient deprived of liberty or under court protection
* Patient under guardianship or curatorship
Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations

This clinical trial aims to assess the impact of patient-focused and clinical-focused implementation strategies on blood pressure control. The investigators will assess the costs of these strategies and how effective they were at safely and equitably increasing home blood pressure monitoring.

This study will focus on assessing implementation strategies to increase adoption of self-monitored blood pressure (SMBP) monitoring among low-income, culturally and linguistically diverse patients with hypertension in an urban safety net. The investigators propose a hybrid type 1 effectiveness-implementation trial of implementation strategies to increase use of SMBP monitoring with clinical support in an urban safety net system. 330 patients will be randomized to a low-intensity vs high-intensity implementation strategy for SMBP monitoring. The low-intensity strategy will replicate frequently used implementation efforts (provision of BP monitor with training on using a monitor) while the high-intensity strategy will address additional factors identified in prior work (e.g., digital literacy, social support). In six adult primary clinics, the investigators will concurrently provide a stepped-wedge clinic-level implementation strategy (clinical champions, electronic health record \[EHR\] tools) to increase provision of clinical support for SMBP data. To guide dissemination in other under-resourced settings, an economic evaluation will also be conducted.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old/order
* Any sex or gender
* Any race or ethnicity
* Must be receiving primary care at any of the six enrolled clinics
* Have uncontrolled hypertension (BP \>=140/90 mmHg at any two encounters in the previous 18 months, including the most recent encounter prior to enrollment)
* Can read and write English, Spanish, or Cantonese
* Be able to provide consent
* Must own a cell phone that receives SMS or text messages

Exclusion Criteria:

* Those with conditions that might complicate remote BP monitoring:

  * Pregnancy (and 12 months postpartum)
  * Acute myocardial infarction or stroke in the last 12 months
  * End-stage renal disease on dialysis
  * Stage D heart failure
  * Active treatment for cancer (except for nonmelanoma skin cancers)
  * Pacemaker use
* Those with dementia, in hospice care, or with serious behavioral health conditions impeding participation
El Faro: Addressing Mental Health Inequities Among Latinx Children With ADHD in Durham

Study team members from El Futuro in Durham, North Carolina have created an intervention called El Faro. El Faro helps Latinx families of children with ADHD understand and cope with the stress and difficulties presented by the disorder. We propose to develop a community-engaged research partnership between El Futuro and the Duke ADHD Program that aims to pilot-test an adapted El Faro treatment.


Eligibility Criteria:
Inclusion Criteria:

* Child is between the ages of 6 to 12 years
* Child has received a previous diagnosis of ADHD in the community based on caregiver report
* ADHD Rating Scale (parent rating scale of ADHD symptoms) symptom severity score of 24 or higher
* Child meets DSM-5 criteria for ADHD (any presentation) based on the MINI
* Generally healthy (i.e., no major medical problems that will interfere with study participation)
* Caregiver's willingness to keep any current psychiatric medication regimen for child diagnosed with ADHD constant throughout the study duration
* Caregiver age 18 years and older
* Caregiver self-identify as Latinx

Exclusion Criteria:

* Caregiver's child has previous diagnosis of Autism, Schizophrenia, or Bipolar Disorder in the community per caregiver report or other psychiatric disorder that is primary to ADHD or may interfere with study involvement.
* Caregiver unable to attend all El Faro sessions
* Plan to initiate new ADHD treatment for identified child with ADHD during study participation (previously established ADHD treatments are allowable)
* Other concerns besides ADHD that would interfere with study participation according to the study team.