cyrilzakka/clinical-trials huggingface dataset:
Omega-3 Fatty Acids in Treating Patients With Advanced Prostate Cancer

This phase I trial is studying the best way to give omega-3 fatty acids in treating patients with advanced prostate cancer. Omega-3 fatty acids may slow disease progression and may be an effective treatment for patients with advanced prostate cancer

OBJECTIVES:

I. To conduct a pilot study of omega-3 polyunsaturated fatty acid (PUFA) (omega-3 fatty acid) supplementation in a group of patients with advanced prostate cancer to assess the dose of omega-3 PUFA necessary to achieve an omega-6 to -3 ratio of 1:1 on an individual basis and to assess the clinical impact of omega-3 supplementation on disease progression

OUTLINE:

Patients receive long-term omega-3 polyunsaturated fatty acid (PUFA) supplementation orally (PO).

After completion of study treatment, patients are followed up at 1, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

Disease is currently controlled with androgen ablation therapy Androgen ablation is expected to continue for at least 1 year Has been treated with androgen ablation therapy for at least 1 month Stable or decreasing prostate-specific antigen (PSA) on androgen ablation therapy Stable or no visible metastatic disease on imaging Eastern Cooperative Oncology Group (ECOG) functional status of at 0 or 1

Exclusion Criteria:

Eligible for local intervention with surgery or radiation Increasing serum PSA on hormonal ablation Radiographic evidence of progression of disease on hormonal ablation Current or history of second malignancy Previously treated with chemotherapeutic agents Previous history of intermittent androgen therapy Gastrointestinal (GI) disease that impacts absorption of nutrients
The French EsoGastricTumours Data Base

This retrospective study aims at evaluating the outcomes of gastrointestinal stromal tumor after surgery.


Eligibility Criteria:
Inclusion Criteria: Patient with

* esophageal cancer, gastric or gastroesophageal junction diagnosed biopsy , regardless of the subtype of cancer, tumor stage or treatment envisaged.
* Naive treatment for this cancer,
* Naive treatment for this cancer , failing that received neoadjuvant treatment ,
* Male or female ≥ 18 years.
* social protection scheme .
* sign a free and informed consent for blood sampling , the different questionnaires and the collection of patient information.

Exclusion Criteria:

Male or female aged ( e) under 18 years.

* Private person of liberty or under supervision (including guardianship ) .
* People who do not speak French.
* Major Nobody unable to consent .
* Patient FREGAT already included in the base.
* Patient Refusal .
Sleep Well Live Well (SWELL) Pilot Project

This will be a 12 week randomized control trial of sleep hygiene education vs. no education with a cross-over to the active intervention after 6 weeks. Primary and secondary outcomes will be assessed before and after a 10-20 minute sleep hygiene video (intervention).

The primary aim of this study is to assess if sleep hygiene education increases sleep duration and sleep quality in an Appalachian community. To accomplish these aims, the investigators will assess changes in sleep duration by the Oura ring and the PSQI and Epworth Sleepiness Scale (ESS). Secondary aims are to determine whether sleep hygiene education decreases heart rate variability measured by the Oura ring and improves alertness as assessed by psychomotor vigilance testing (PVT). Potential participants will be recruited via brochures, poster displays and on-line media to participate in the study. Those eligible will be asked to complete a questionnaire to record baseline demographics. The data collected will be demographic information, presence of chronic medical conditions, validated sleep questionnaires, PVT results and Oura ring (https://ouraring.com/) output. A total of 100 subjects (50 per group) will be randomized to each treatment group, stratified by gender. The first group will receive the intervention and be enrolled into the trial after the run-in period and the baseline data collection, and the second group will receive the intervention at 6 weeks after trial start. Each subject (in both groups) will have pre- and post-intervention data in this study. Therefore, the "real" control in this study is the subject himself/herself (after taking the difference), which will minimize any confounding factors/effect; If the investigators assume that more education duration will result in more benefit, the investigators have a chance to assess a dose-response curve ("dosage" = education duration). The investigators will fit a mixed-effects model with duration as a fixed effect, adjusting for potential confounding variables if any.

Eligibility Criteria:
Inclusion Criteria:

* Reside in Harrison County of West Virginia
* Ability to read and understand English
* Ability to provide informed consent

Exclusion Criteria:

* Inability to read and understand English
* Inability or unwillingness to provide informed consent
* Presence of sleep apnea
* Depression
* Severe insomnia
* Using prescription sleeping medication or narcotics
* Acute illness including stroke, heart attack, heart failure or pneumonia with or without COVID-19 infection requiring hospital admission within the last 8 weeks
Verification of Correlation Between Genetic Testing of Nutritional Metabolism and Clinical Biochemical Indicators

The research plan is divided into two parts. The first part is the correlation study .It is planned to include women who prepare for pregnancy or in the early stages of pregnancy to carry out the detection of 25 loci SNP of 21 genes of 9 nutrients, to predict the nutritional abnormalities of 9 nutrients, and to determine the nutritional status of 9 nutrients, and then verify the correlation between nutrient metabolism related gene SNP and nutrient nutrition status .The second part selects iron and selenium which are commonly lacking in Chinese women of childbearing age. A intervention study is designed for these two nutrients. According to the SNP grouping of related gene loci, observe the effect of nutrition intervention and explore the nutrition intervention strategies of different SNP individuals.


Eligibility Criteria:
Inclusion Criteria:

* preparing for pregnancy or early pregnancy women (\< 12w)
* no major surgery, trauma, or important viscera disease
* no long-term medication history
* No serious mental and psychological behavior abnormalities
* resident in Beijing, can accept regular prenatal in Beijing area
* signed informed consent

Exclusion Criteria:

* have taken medications that may affect the metabolism of nutrients, but are unable to provide their ingredients or doses, making it difficult to judge their effects
* From the first three months of this pregnancy to the time of inclusion, taking drugs that interfere with the absorption, metabolism, and utilization of nutrients.
* From the first three months of this pregnancy to the time of inclusion, Pregnant woman took iron, selenium, vitamin B6, vitamin B12, vitamin D preparations, and the dosage was higher than the corresponding physiological standard.
Detection of Biomarkers in Abnormal Cervical Cells in Women With Abnormal Pap Test Results

RATIONALE: Examining biomarkers in abnormal cervical cells may improve the ability to detect these cells and plan effective treatment.

PURPOSE: Diagnostic trial to detect specific biomarkers in abnormal cervical cells in women who have abnormal Pap test results.

OBJECTIVES: I. Compare the detection of transferrin receptor, epidermal growth factor receptor, and the MaTu-MN protein in exfoliated cervical epithelial cells from women with abnormal Pap test using fluorescent labeled antibody probe vs histology.

OUTLINE: Patients undergo a Pap test and a colposcopy. Cervical epithelial cells are collected from the most abnormal appearing lesion. Cells are examined for molecular markers using a fluorescent antibody test. The presence or absence of these markers is compared to results of the Pap test and the histology of the cells.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of abnormal Pap test, as indicated by one of the following: Atypical squamous cells of undetermined significance (ASCUS) Low grade squamous intraepithelial lesion (LGSIL) High grade squamous intraepithelial lesion (HGSIL) Visible lesion on cervix by colposcopy

PATIENT CHARACTERISTICS: Age: Any age Performance status: ECOG 0-4 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Pregnant or nursing women allowed

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior pelvic irradiation Surgery: No prior total hysterectomy
A Phase 1 Dose Escalation and Expansion Study Of SHR-1916 In Subjects With Locally Advanced Or Metastatic Solid Tumors

This is a first in human, open-label, dose escalation and expansion Phase 1 study of SHR-1916 in adult patients with locally advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and the willingness to sign a written informed consent document；
2. Aged between 18-75 years old;
3. Histologically or cytologically confirmed advanced or metastatic malignant tumor;
4. Presence of at least of one measurable lesion in agreement to RECIST criteria;
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
6. Life expectancy \>12 weeks;
7. Adequate organ performance based on laboratory blood tests;
8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

1. Patients who have received cytokines (IL-2, IFN-α)as anti-tumor therapy within 6 months before the first dose;
2. Previous systemic therapy within 28 days before the first dose;
3. Previous therapeutic surgery within 28 days, and diagnostic surgery within 14 days prior to the first dose;
4. Received live attenuated vaccine within 28 days before the first dose, or expected to receive live attenuated vaccine during the study treatment period;
5. Patients who received systemic immunosuppressive therapy within 14 days before the first dose;
6. Patients with known or suspected brain metastasis；
7. Subjects with interstitial pneumonia or interstitial lung disease, with a history of interstitial pneumonia or interstitial lung disease limiting self care ADL or with life-threatening respiratory compromise, with a history of pulmonary fibrosis, lasting pneumonia, drug- or radiation-induced pneumonia, and congenital pneumonia that may otherwise interfere with the judgement of immune-related pulmonary toxicity, or with any evidence of active pneumonia as shown on chest CT scans;
8. Patients with history of autoimmune diseases;
9. History of immunodeficiency (including HIV infection) or organ transplantation;
10. Known active hepatitis B or C infection;
11. Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment.
Expanded Access Use of Itacitinib to Treat a Single Patient With STAT1 Gain of Function (GOF) Disease

Expanded access use of Itacitinib to treat a single patient with aplastic anemia.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Smart Prostate Specific Antigen (PSA) Screening Study

This intervention includes the introduction of the Prostate Cancer Working Group (PCWG )Smart PSA Screening Guidelines and implementation of patient navigation/ care coordination for men with elevated PSA (\>4.0 ng/mL).

The guidelines include:

1. What age to start?
2. How often to repeat screening?
3. What age to stop?
4. What PSA threshold should trigger a biopsy referral?

Primary care providers (PCP) hold the key to implementing effective early detection of Prostate Cancer (PCa), but uncertainty about how to use PSA for screening without causing undue overtreatment of indolent cancer, has greatly inhibited implementation, even in high-risk communities. This is a single-arm intervention study to test implementation of the Smart PSA strategy plus system-level patient navigation/ care coordination in the Mile Square Health Center(MSHC), in order to: a) identify barriers and facilitators to inform implementation of care, b) evaluate the impact on provider confidence regarding prostate cancer screening, and, c) measure its effect on observed PSA levels, biopsy referral rates, and biopsy outcomes.

100 PCPs employed by MSHC who provide care for male adults will be asked to participate in surveys at baseline, (prior to an in-service training) and at 3,6, 9 and 12 months. The surveys will use 5-point Likert scales to assess the respondent's self-report of their knowledge regarding PSA screening, attitudes, behavior; and confidence in presenting the issue, discussing it with patients, interpreting results and making recommendations based on them; and to elicit comments on how to improve implementation.

Historical data of 4500 patients covering a one year period prior to the intervention will be used to measure the impact of the intervention on measurable outcomes

Eligibility Criteria:
Inclusion Criteria for PCP:

* PCP employed by MSHC who provides care for male adult patients

Exclusion Criteria for PCP:

* Not a PCP employed by MSHC who provides care for male adult patients

Inclusion Criteria for Patient navigator/care coordinator:

* Male
* Age 40-75
* Clinic visit at a MSHC site
* Elevated PSA (\>4.0 ng/ml)

Exclusion Criteria for Patient navigator/care coordinator:

• Not meeting the inclusion criteria

Inclusion criteria for chart and database review:

* Male
* Age 40-75
* Clinic visit at a MSHC site from date of study start through 12 months (comparison of 12-month intervention period to periods before and after intervention implementation)

Exclusion Criteria for chart and database review:

• Not meeting the inclusion criteria
Bi-atrial Versus Left Atrial Ablation for Patients With Rheumatic Mitral Valve Disease and Non-paroxysmal Atrial Fibrillation

This study is aimed to compare the efficacy of bi-atrial ablation with left atrial ablation for atrial fibrillation during mitral valve surgery in patients with rheumatic mitral valve disease.

Atrial fibrillation (AF) is present in 40%-60% of patients with rheumatic mitral valve disease (RMVD), which is an independent predictor of mortality and late stroke. During mitral valve (MV) surgery, the open left atrium facilitates a bi-atrial ablation procedure. However, a simplified lesion set including isolated pulmonary vein isolation or posterior left atrial (LA) wall isolation or LA maze was usually applied. The current literatures provide insufficient evidence to determine the potential benefits of bi-atrial ablation procedure when comparing with LA ablation procrdure in patients with non-paroxysmal AF and RMVD.

Patients with RMVD often have longer history, which tends to affect the right atrium, including pulmonary hypertension or tricuspid regurgitation.The necessity of bi-atrial ablation procedure targeting the bi-atrial substrate for AF in RMVD requires to be explored. In this study, we aimed to compare the efficacy of bi-atrial ablation with LA ablation for AF during MV surgery in patients with RMVD.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of persistent atrial fibrillation(AF) or long-standing persistent AF by medical history and Holter monitoring (persistent AF lasting more than 7 days; long-standing persistent AF lasting more than 1 year).
* Rheumatic mitral valve disease(RMVD) requires mitral valve surgery( RMVD was determined by history of acute rheumatic fever, valve morphology, echocardiographic findings and pathological diagnosis).
* Consent to surgical ablation of AF

Exclusion Criteria:

* Paroxysmal AF
* Degenerative or ischemic mitral valve disease
* Evidence of active infection
* Previous catheter ablation or surgical ablation for AF
* Surgical management of hypertrophic obstructive cardiomyopathy
* Absolute contraindications for anticoagulation therapy
* Left atrial thrombosis (not including left atrial appendage thrombosis alone)
* Chronic obstructive pulmonary disease(Forced expiratory volume in 1 second (FEV1)\<30% anticipated value)
* Uncontrolled hypo- or hyperthyroidism
* Mental impairment or other conditions that may not allow participants to understand the nature, significance, and scope of study
* Left atrial diameter\>70mm
* Right ventricular dysfunction (TAPSE\<16) or moderate to severe tricuspid regurgitation or pulmonary artery pressure (estimated by echocardiography) \>60mmHg
* Coronary artery bypass grafting is required for participants with coronary heart disease
* Previous cardiac surgery
* Refuse to participate in this study
Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

The study objective is to determine whether an ICS added for 4 weeks to a baseline treatment with a Long-Acting Beta-adrenergic Agonist (LABA) and Long-Acting Muscarinic Antagonist (LAMA) combination improves pulmonary vascular endothelial function as assessed by the vasodilator response to inhaled albuterol (endothelium-dependent vasodilation) in stable COPD patients treated with a LABA/LAMA without an ICS for at least one month.


Eligibility Criteria:
Inclusion Criteria:

* physician diagnosis of COPD
* former smoking history of more than 10 pack-years
* baseline post-bronchodilator one-second forced expiratory volume (FEV1) 50-80% of predicted, baseline FEV1 and forced vital capacity (FVC) ratio \<0.7
* males and females, 40-80 years of age
* regular use of a LAMA/LABA drug regimen for at least a month

Exclusion Criteria:

* women of childbearing potential who do not use accepted birth- control measures
* pregnant and breast-feeding women
* respiratory infection within 4 weeks of a test day
* a Corona Virus Disease (COVID) vaccination \<3 months prior to study entry
* ICS use (within 4 weeks of study entry)
* ICS hypersensitivity
* albuterol intolerance
* use of beta-blocker medication (oral and ophthalmic)
* use of systemic glucocorticosteroid medication within 6 wk prior to the screening visit
* an acute COPD exacerbation within 6 wk of the screening day (defined as a need for antibiotic or systemic glucocorticoid therapy or emergency department (ED) visit/hospitalization)
* current smoking or vaping tobacco or other products
* Oxygen (O2) saturation of \<90% at-rest breathing room air
* Long-term oxygen therapy (LTOT) required at rest
* regular use of pulmonary vasodilators
* systemic arterial systolic pressure \>150 mmHg and diastolic pressure \>100 mmHg on the test day
* a \>40mmHg right ventricular systolic pressure (RVSP) by prior echocardiography
* a documented COVID infection within 4 weeks of the screening day
* Regular use of home oxygen at rest
* Physician diagnosis of obesity hypoventilation syndrome
A New Technique to Diagnose Acute and Chronic Deep Vein Thrombosis

In clinical practice, compression ultrasound (CUS) has become an easy and reliable noninvasive tool for the diagnosis of deep vein thrombosis (DVT).

Currently there are not validated methods to assess the biological age of venous thrombus, and the date of onset of thrombosis. One potential technique to age DVT is ultrasound elastography (UE). UE is a noninvasive technique to measure tissue hardness, and it is well known that thrombi harden as they age. The aim of this study will be to assess the ability of UE to distinguish acute from chronic DVT. The investigators will evaluate prospectively all consecutive outpatients presenting with clinically suspected unprovoked DVT of the lower limbs, and those having a previous diagnosis of DVT for the scheduled 3 months visit of follow-up, for a period of about one year. All the enrolled patients will undergo to the CUS of the lower limbs, and at the same time to the ultrasound elastography by the physician expert in vascular ultrasound. The specialist performing both examinations will be unaware of the time of onset of DVT (acute or chronic). Then the patients will be divided into two groups (group A: patients with acute DVT; group B: patients with chronic DVT at the 3rd month of follow-up). Each examination (CUS and ultrasound elastography) will be repeated three times in the same patient at the same visit, to assess the reproducibility of the technique. The demographic data, medical history, physical examination and the results of CUS and ultrasound elastography will be collected in a case report form (CRF) by another investigator who does not perform the examinations. The blinded CRF will be submitted to a dedicated committee for statistical analysis.


Eligibility Criteria:
Inclusion Criteria:

* acute first episode of unprovoked DVT of lower limbs
* chronic first episode of unprovoked DVT of lower limbs (at third month of follow up)

Exclusion Criteria:

* previous episodes of DVT
* ongoing anticoagulation
* age younger than 18 years
* pregnancy
PENG Block vs Sciatico Femoral Block in the Incidence of Post Amputation Syndroms

assess the effectiveness of peri-capsular nerve group block and scaitico femoral block in the incidence of post amputation syndrome in patients undergoing above knee amputation.

The loss of a body part can lead to pain and other sensations that fall into three distinct descriptive categories, namely phantom sensations, phantom pain, and residual pain. Phantom sensations are defined as pain-free perceptions emanating from the lost body part after deafferentation, and phantom pain is a painful or unpleasant sensation in the distribution of the lost or deafferented body part 5. Phantom sensations can be a different expression of phantom pain and interfere with rehabilitation therapy by enhancing and interacting with phantom pain.

The current standard of care is pre-operative nerve blockade to prevent peripheral sensitization leading to future onset of phantom limb pain. Successful outcomes necessitate effective communication between the surgeon, anesthesiologist, and the various teams involved in the post-operative rehabilitation of the patient. A consultation with the Acute Pain Service or similar entity that performs peripheral nerve blockade pre-operatively and then follows the patient during their post-operative inpatient course is an important factor in the success in early prevention of acute and chronic pain for these patients.

Pericapsular nerve group block or PENG block is a novel regional nerve block to provide analgesia in fractured hip patients. It is primarily an ultrasound-guided (USG) technique where target area is the pelvic rim (superior pubic ramus) near iliopectineal eminence, deep to fascia of iliopsoas muscle. Articular branches of femoral nerve and accessory obturator nerves, which cross over the bony rim, are primary targets of the PENG block.however, by increasing volume of local anesthetic drug; other nerves (obturator, femoral, genitofemoral, and lateral femoral cutaneous nerve) can be blocked.

This block is a new regional anesthesia technique based on blocking the femoral nerve (FN) and accessory obturator nerve (ON) with a single injection.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I and II
* Age above 20 and less than 60 years.
* Patients undergoing above knee amputation due to any type of cancer

Exclusion Criteria:

* Patient refusal.
* Local infection at the puncture site.
* Coagulopathy.
* Cognitive disorders.
* Unstable cardiovascular disease.
* History of psychiatric disorders.
* History of drug abuse.
* Patients allergic to medication used.