cyrilzakka/clinical-trials huggingface dataset:
Study of Blood Samples From High-Risk Postmenopausal Women Who Received Treatment on Breast Cancer Prevention Clinical Trials NSABP-P-1 or NSABP-P-2

RATIONALE: Studying the genes expressed in samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples from high-risk postmenopausal women who received treatment on breast cancer prevention clinical trials NSABP-P-1 or NSABP-P-2.

OBJECTIVES:

Primary

* To identify genes associated with breast events (i.e., the occurrence of invasive breast cancer or ductal carcinoma in situ), in terms of single-nucleotide polymorphisms (SNPs) in a genome-wide association study, in Caucasian women at high risk of developing breast cancer who have received a selective estrogen receptor modulator (SERM) (i.e., tamoxifen or raloxifene) on the NSABP-P-1 OR NSABP-P-2 breast cancer prevention clinical trials.
* To determine the impact of CYP2D6 metabolizer status, which includes genotype and status of concurrent use of CYP2D6 inhibitors, on breast cancer events in participants receiving either tamoxifen or raloxifene.

Secondary

* To explore whether multiple SNPs within a region are independently associated with a breast event.
* To explore whether there are interactions among SNPs that increase the risk for a breast event.
* To explore whether there is interaction of any SNPs identified in the primary objective with randomized treatment, in terms of the risk for a breast event.
* To identify rare variants that might affect estrogen-dependent expression of chromosomes (CTSO) 4 and 16 (ZNF423) and/or the relationship to BRCA1 expression.

OUTLINE: Samples are stratified according to CYP2D6 genotype and CYP2D6 metabolizer status.

DNA extracted from previously collected blood samples is analyzed in a genome-wide association study and compared with 2 control samples from patients who did not experience a breast event. DNA samples are used to identify and analyze single nucleotide polymorphisms.

Also, exploratory analyses are conducted examining the impact of CYP2D6 metabolizer status on breast cancer events according to invasive vs non-invasive disease, ER status, PgR status, histologic type, and TMN stage.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Previously treated on the NSABP-P-1 Breast Cancer Prevention clinical trial

    * Caucasian women that did or did not experience an invasive breast cancer or ductal carcinoma in situ (DCIS)
    * At least 50 years of age at time of entry to P-1
  * Previously treated on the NSABP-P-2 Breast Cancer Prevention clinical trial

    * Caucasian women that did or did not experience an invasive breast cancer or DCIS
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Postmenopausal status

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Labour Pain is a Subjective Experience. The Degree of a Woman's Suffering in Childbirth Depends on Indirect Factors

Pain During Childbirth is a Complex and Subjective Experience. The Degree of a Woman's Suffering in Childbirth Depends on the Intensity of Labour Pain and Many Indirect Factors. Complex Interrelated Effects on Labour Pain Are Limited by the Little Number of Studies Available. That is Why it is Necessary to Determine the Probable Factors That May Affect the Intensity of Pain.

A prospective observational study was conducted in the period from December 2020 to May 2021 at the Kyiv City Maternity Hospital №5 (Kyiv, Ukraine). The study protocol was approved by the Bogomolets National Medical University Ethics Committee. The examined predictors were derived from mothers' self-report of overall childbirth. 366 women took part in research, 282 of participants rated their pain by ≤ 60 mm visual analog scale (VAS), while 84 patients reported their pain by ≥70 mm VAS. The aim of study was to investigate predictors of severe labour pain. In the postpartum period all patients filled questionnaires and underwent interviews from the 1st to the 3rd day after delivery. The following groups of risk factors were studied:

1. Demographic indicators (age, level of working capacity 2 months before childbirth, attendance of maternity school).
2. General level of health (woman's level of health before childbirth, daily physical activity before childbirth, bad habits - smoking during pregnancy).
3. Presence of mental disorders before childbirth (level of anxiety 2 weeks before childbirth, widespread muscle pain with fatigue or problems with memory, sleep, and mood).
4. The presence of chronic pain, chronic headache or chronic back pain, the presence of rheumatoid arthritis during pregnancy, the presence of increased intracranial pressure during pregnancy.
5. Presence of chronic intestinal diseases (irritable bowel syndrome).
6. The level of assistance during childbirth (constant support of the doula during childbirth, the woman's ability to control pain in childbirth).

Eligibility Criteria:
Inclusion Criteria:

* mothers over 18 years of age, 1st or 2nd parturitions, childbirth with the birth of the alive fetus.

Exclusion Criteria:

* mothers over 45 years of age, inability to obtain the informed consent of the patient or his legal representative.
Use of Armodafinil for Fatigue in Sarcoidosis

To determine the effect of Armodafinil (Nuvigil) on fatigue and sleep in sarcoidosis.

The study will be divided into two halves. Patients will receive either drug or placebo in the first half. Patients receiving active drug will be started at one dose and it can be increased at the second visit. Those patients randomized to placebo will also have their dose adjusted by the investigating physician. The physicians will be blinded as to whether the patient is receiving drug or placebo. In the second half of the study, patients will receive the opposite treatment.

Patients will have complete detailed questionnaires regarding their fatigue, sleepiness, and overall quality of life.

They will have sleep studies done at the start and after each half of the study to determine the effect of therapy on sleepiness.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sarcoidosis using standard criteria 15.
* Disease for more than one year
* On stable, systemic therapy
* Complain of fatigue which has been present for more than six months.
* Over 18 years of age
* Provide written informed consent.

Exclusion Criteria:

* Pregnancy
* Change in therapy for sarcoidosis in prior three months
* History of ventricular arrythmias
To Evaluate the Effect of Wound Infiltration With Bupivacaine for Post-operative Pain Relief After Laparoscopic Cholecystectomy

To evaluate the effect of wound infiltration with 0.25% Bupivacaine in laparoscopic cholecystectomy in terms of pain severity, patient satisfaction level, quality of life, hospital stay and return to job and normal activities.


Eligibility Criteria:
Inclusion criteria

* Patients scheduled to undergo laparoscopic cholecystectomy under general anesthesia at department of surgery and department of hepatobiliary system, BSMMU
* Patients who are eligible according to ASA Ⅰ -Ⅱ
* Female or male, age ≥18 years
* Patients who are scheduled for same anesthetic technique and surgical procedure for laparoscopic cholecystectomy
* Discharge of patient between 12 hour to 36 hour after performing procedure
* Patients given consent for enrollment in study

Exclusion criteria

* Patients known to be allergic to certain recommended drugs
* If patients have history of psychiatric illness
* Patients on chronic analgesic therapy for any other indication
* Patients who are scheduled for different anesthetic technique and surgical procedure for laparoscopic cholecystectomy
* Duration of surgery more than 1 hour
* Patients undergoing laparoscopic cholecystectomy for complex gallbladder disease such as incidental gallbladder pancreatitis, gallstone pancreatitis, cholecystoduodenal fistula, mirizzi syndrome
* Special population group such as children, pregnant woman, patients with cirrhosis, diabetics
* Duration of operative procedure more than 1 hour
HErnias REparation After Kidney Transplantation Study

Correlation between hernias reparation in patients who have received a kidney transplant. The investigators will analyze the data of patients who have been treated for reparation of incisional hernia after kidney transplantation with or without the placement of a prosthesis.

In the scientific literature, the percentage of post incisional hernia in kidney transplanted patients is very variable, and not too well-argued, especially in the context of prevention and individuation of risk factors.

The increase of surgical management of hernias reparation in renal transplant patients justifies the start of a mon-centric type study. The investigators will look for risk factors with a retrospective, observational study, by analyzing the type of surgical repair of their post-surgical wall defect.

The analysis of costs/benefits on postoperative, intraoperative, or preoperative prevention will be taken into account.

Eligibility Criteria:
Inclusion criteria:

- hernia post renal transplantation

Exclusion criteria:

- underage
Validation of Medication Non-adherence Model (UK)

Research has shown that nearly 50% of patients with chronic conditions around the globe do not adhere to their prescribed medicine, leading to enormous cost to the healthcare providers. Non-adherence can be due to various forms and have multiple causes.

To address this need, Philips Research has developed Medication Non-adherence model. This tool will help in developing a systemic way of assessing medication non-adherence and providing decision support for targeted intervention to healthcare professionals. The aim of this study is to validate this model with 750 chronically ill patients in UK.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic disease between 18 -89 years old.
* Chronic medication use (\> 3 medications; excluding analgesic, ointment and eye drop medication)
* Patients registered with a given Pharmacy at least 1 year before entering into the study.

Exclusion Criteria:

* Patients who are illiterate in English.
* Patients who are unable to give consent to the study.
* Enrolled in another clinical trial, which requires change in their routinely medication.
* Patients currently using automatic medication reminder services (excluding the pharmacy service).
* Patients with dementia or any other mental conditions, that might affects the accuracy of the answers provided.
A Study Comparing the Effects and Safety of Dulaglutide With Insulin Glargine in Type 2 Diabetes Mellitus

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to once-daily insulin glargine in participants with type 2 diabetes mellitus who have inadequate glycemic control with 1 or 2 oral antihyperglycemic medications (OAM) (metformin and/or a sulfonylurea), in addition to any healthy lifestyle changes recommended by their healthcare providers.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes mellitus for at least 6 months
* Have been taking metformin and/or a sulfonylurea for at least 3 months before screening and have been on a stable therapeutic dose for at least 8 weeks
* Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤11.0%
* Adult men or adult non-pregnant, non-breastfeeding women
* Body Mass Index (BMI) of ≥19.0 to ≤35.0 kilograms/square meter (kg/m\^2)
* Stable weight (±5%) ≥3 months prior to screening

Exclusion Criteria:

* Have type 1 diabetes mellitus
* Have previous treatment with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic
* Have treatment with dipeptidyl peptidase-IV (DPP-IV) inhibitor, an alpha-glucosidase inhibitor (AGI), thiazolidinedione (TZD), or glinide
* Have gastric emptying abnormality
* Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke
* Have poorly controlled hypertension (systolic blood pressure above 160 millimeter of mercury\[mmHg\] or diastolic blood pressure above 95 mmHg)
* Have impaired liver function
* Have impaired kidney function
* Have history of chronic pancreatitis or acute pancreatitis
* Have a serum calcitonin ≥20 picograms per milliliter (pg/mL)
* Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma, or multiple endocrine neoplasia type 2 (MEN 2)
The Protein Disrupted in Schizophrenia 1 (DISC1) as a Novel Biomarker for Cardiac Disease

To study the association between DISC1 RNA expression levels and cardiac function in patients with schizophrenia.

Potential participants interested in the study will be screened for eligibility. Those who meet the eligibility criteria will be informed about the study, the expected investigations and its potential risks. All participants giving written informed consent will be enrolled into the study. Participants will be interviewed, given questionnaires, have blood and/or skin samples and clinical parameters taken. Cardiac function parameters will be measured using electrocardiography, echocardiography and magnetic resonance imaging.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ICD-10 schizophrenia, schizotypal or delusional disorders (F20 to F29)
* Both inpatient and outpatient
* Capable of giving informed consent

Exclusion Criteria:

* Current or previous diagnosis of cancer
* Current or previous treatment with chemotherapy
* Current pregnancy
* Mothers less than 6 months post-partum
Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors

This is a single arm, phase I study, evaluating the feasibility, toxicity, and degree of tumor response after novel proton pencil beam scanning (PBS GRID) treatment in patients with bulky tumors that are difficult to manage.

The proton group at Sibley Memorial Hospital has developed a new method for multi-beam proton delivery making it possible to arrange and optimize GRID dosimetry and normal tissue sparing compared to other similar techniques.

In this phase I pilot study, patients with bulky tumors will receive this novel method of GRID-therapy also called spatially-fractionated radiotherapy which involves delivering high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor and is often aligned in a grid pattern.

In so doing, this study will ascertain the feasibility, safety and tumor response i.e. shrinkage and resectability of this treatment. Ultimately, the goal is to improve local outcomes of patients with bulky tumors and to offer new treatment options for patients with difficult-to-manage bulky tumors.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Histologically or cytologically confirmed invasive cancer
* Bulky tumor \> 7 cm, determined clinically and/or radiographically, at the time of evaluation prior to enrollment
* Treated indicated for palliative intent
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2
* Anticipated treatment deemed safe on pre-review by PI
* For patients with prior Radiation Therapy (RT): Dicoms must be available for dose fusion if overlap anticipated with GRID
* Willing and able to provide informed consent
* Discussion with medical oncology or surgical specialty

Exclusion Criteria:

* Age \< 18
* ECOG performance status 3-4
* Planned for definitive, curative management
* For patients with prior RT that overlaps with Pro-GRID: Dicoms not available Pregnant women
* Tumor encasing critical structure, as defined by the treating MD.
Three Dimensional Versus Two Dimensional Laparoscopic Salpingectomy in Patients With Hydrosalpinx Undergoing IVF-ET

A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being utilized in daily practice despite debates about its success.

A three-dimensional laparoscopic vision system (3-D LVS) has gained acceptance and is being utilized in daily practice despite debates about its success. in our study we will compare operative data and early postoperative outcomes of laparoscopic salpingectomy operations conducted using standard 2-D and 3-D laparoscopic vision systems

Eligibility Criteria:
Inclusion Criteria:

* Patients with unilateral hydrosalpinx diagnosed with hysterosalpingography or laparoscopy

Exclusion Criteria:

* Bilateral hydrosalpinx,
* co-existent adnexal pathology,
* body mass index (BMI) more than 40,
* extensive pelvic adhesions,
* coagulation defects or concurrent anticoagulant therapy,
* compromised cardiopulmonary status,
* and contraindications for general anesthesia.
Testing the Persuasiveness of Pro-inoculation Arguments

The investigators will recruit a national sample of parents of 7-10-year-olds to complete an argument strength ranking for either a simple forwarding message or between 3 and 6 randomly selected arguments from an overall set of 50 to 100 messages identified from various online sources. Parents will rate each message they see on measures of perceived argument strength/PME. Parents will also answer sociodemographic questions and then rank the believability of a set of anti-vaccine messages identified in a different study. Study findings will contribute valuable information to understanding the effectiveness of different inoculation messages.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female parent or legal guardian of an adolescent ages 7-10
2. Age eligible child has not yet received any doses of the HPV vaccine
3. Resides in the United States
4. English speaking
5. Completed informed consent

Exclusion Criteria:

1. Unable to read English at a 6th grade literacy level
2. Age \< 18
3. Does not have a child within the age range of 7-10
4. Age-eligible child has received 1 or more doses of the HPV vaccine
5. Does not have a social media account on one or more of the following platforms OR does not read online news stories: Twitter, Instagram, YouTube, Facebook (feasibility testing only - survey participation will not have this exclusion criteria)
6. Unwilling or unable to provide informed consent to study participation
The Use of 5-aminolevulinic Acid (ALA) as an Intraoperative Tumor Marker for Resection of Pediatric Central Nervous System (CNS) Tumors

Surgery is the cornerstone treatment of most pediatric CNS tumors, including astrocytomas, ependymomas, medulloblastomas, and many other pathologies.

In most pediatric CNS tumors, the aim of surgery is maximal tumor resection, while preserving neurological function. Extent of tumor residual has been shown to be a major prognostic factor for progression free survival (PFS), and survival in several malignant and low-grade tumors such as medulloblastomas, ependymomas, and astrocytic tumors.

5-aminolevulinic acid (5-ALA) has been shown to be valuable in intraoperative marking of various cancers. Following oral admission, during surgery, the tumor tissue is illuminated by blue light. Tumor cells tend to metabolize 5-ALA to a porphyrin named protoporhyrin IX (PpIX). PpIX reacts with the blue light and emits a pinky color (- fluorescence). This enables the surgeon to better identify tumor cells and perform a more extensive resection.

Over recent years, many studies have proven the efficacy using 5-ALA for resecting various intracranial and spinal tumors, thus achieving a better tumor control.

In the suggested study, we propose using the same technique for various pediatric central nervous system tumors.

We will focus on the correlation between various pathologies and the fluorescence, trying to deduce the role of 5-ALA in resection of specific pathologies.

Also, we will study the safety of 5-ALA use in the pediatric population.

Following the above general description, eligible children will receive 5-aminolevulinic acid (5ALA) prior to surgery.

During surgery, careful attention will be payed to the fluorescence from the tumor, as well as the ability to differentiate between tumor and non tumorous tissue.

Comparisons between fluorescence and pathologies will be performed. Additionally, careful documentation of side effects will be done, to increase the safety of 5ALA use.

Eligibility Criteria:
Inclusion Criteria:

* Age 3 -18 years old
* Any CNS related pathology (including intraaxial and extraaxial tumors, intracranial or spinal intradural) that is planned for either open (microscopic) resection (or biopsy), or lesions undergoing stereotactic biopsies.
* Parental consent
* No personal or familial (1st degree) history of porphyria
* Liver function test within normal limits (alanine aminotransferase (ALT), aspartate aminotransferase (AST)\<2 \* upper normal limit)
* Normal renal function (Cr \<2)

Exclusion Criteria:

* Surgery with no microscopic use (i.e. purely endoscopic surgeries)
* History of hepatic disease within last 12 months
* History of cutaneous photosensitivity, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis, or porphyria
* Inability to comply with photosensitivity precautions
An Open-Label Pilot Study of VTX2735 in Recurrent Pericarditis

This is a study to understand if taking VTX2735 is safe and effective in participants diagnosed with Recurrent Pericarditis (RP). Approximately 30 patients will take VTX2735.

The study consists of a 30-day Screening Period (to see if a participant qualifies for the study), a 6-week Open Label Treatment period (a participant receives active Dose A), a 7-week Extension Treatment period (a participant meets criteria for continuing and receives active Dose A) and a 14-day Follow-Up Period.


Eligibility Criteria:
Inclusion Criteria:

* Participants are male or female ≥ 18 years up to ≤ 75 years of age.
* Capable of giving signed informed consent and able to comply with the protocol
* Previously had an index (first) episode of pericarditis which met the criteria for an acute pericarditis event
* Ongoing symptomatic episode of pericarditis, or may have an episode of recurrent pericarditis in the next 4 weeks.
* CRP by local laboratory assessment prior to first dose of study treatment (participants with CRP ≤ 1 mg/dL must be receiving corticosteroid treatment for RP and have evidence of pericardial inflammation)
* Pericarditis pain score ≥ 4 based on the 11-point NRS.
* Stable doses of NSAIDs, colchicine, and/or oral corticosteroids (if receiving these treatments)

Exclusion Criteria:

* Current or prior diagnosis of pericarditis that is secondary to specific prohibited causes, including but not limited to tuberculosis, blunt trauma, tumor, myocarditis, or systemic autoimmune diseases.
* History of clinically significant immunosuppressive disorder, autoimmune/autoinflammatory disorder, or primary or secondary immunodeficiency.
* Clinically important history of a medical disorder that would compromise safety or data quality, per the Investigator's judgment.