cyrilzakka/clinical-trials huggingface dataset:
Assessing the Effects of Omega-3 Supplementation on Some Serum BDNF، Follistatin، Irisin Levels in Men With CAD

The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BDNF، Follistatin، Irisin in patients with cardiovascular disease.

The aim of this study is the comparison between the effects of supplementation with omega 3 or placebo for 8 weeks in serum level of BDNF، Follistatin، Irisin in patients with cardiovascular disease. In this randomized, double-blind clinical trial, placebo-controlled, single-center, and phase two trials, 42men aged 45-65 years with Coronary Artery Disease are enrolled in the study from Tehran Heart Center. After signing informed consent all individuals complete a general information form , 24-hour food recall for 3 days will be taken from the participants at the beginning and the end of the study,. Selected samples are randomly classified into 2 blocks of groups receiving supplement and placebo. The supplement group, will receive 4 g/day omega 3 fatty acid for 8 weeks and the placebo group will also receive placebo (containing 4 g of edible paraffin) (similar in terms of color, shape and size). Patients are recommended to sustain their diets and medication dose (s) during the study and also advised to maintain a constant level of physical activity. Blood samples will be collected after 8-12 hours fasting and anthropometric variables, biochemical parameters and physical activity before and after the trial will be measured.

Eligibility Criteria:
Inclusion Criteria:

* cardiovascular disease patients 45- 65 years old,
* patients with ≥ 50% stenosis in at least one coronary angiogram demonstrated,
* body mass index in the range 18.5- 35,
* avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention,
* willingness to participation,

Exclusion Criteria:

* people who have used omega 3 supplements in last 3 months,
* having chronic renal disease ,
* GI disease,
* hepatobiliary diseases,
* hematological disorders,
* movement disorders,
* myopathy ,
* hypo- or hyperthyroidism,
* Smokers
Evaluation of the Potential Impact of an Artificial Intelligence Solution in Second Reading of Organized Screening.

Based on data from a series of patients who underwent screening mammography with a "normal" or "benign" first-reading result. The main objective of the study is to evaluate the possibilities of subtracting from the second reading of breast cancer screening a population of examinations for which the risk of discovering cancer is close to zero, using an AI system (here the MammoScreen™ system).

This is a retrospective multicenter study of mammography imaging data contained in the PACS (Picture Archiving and Communication System) of six radiology centers located in the Rhône, Puy de dôme, Cantal and Haute-Loire départements.

In order to be able to collect two-year follow-up data, the files analyzed will concern all women who received a screening mammogram during the years 2015, 2016, 2017, 2018 and 2019. More recent mammograms will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 50 to 74 participating in the organized screening campaign.
* Having had a screening mammogram with a final L1 result of "normal" (ACR 1/ BI-RADS 1) or "benign" (ACR 2/ BI-RADS 2).
* For which a second reading interpretation is available
* Screening mammograms performed during the years 2015 to2019 (In order to have follow-up data (subsequent mammogram or information on the person's future)

Exclusion Criteria:

- Mammography not performed as part of organized screening
Microlyte Dressing in the Management of Wounds

The purpose of this pilot study is to assess the efficacy of Microlyte Ag wound dressing when used in complex skin wounds. Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans. Primary clinical end point of study is percentage change in wound size from initiation of Microlyte Ag treatment through 90 days or until wound closure. Patient population comprises patients referred to Mission's Wound Healing and Hyperbaric Center for management of their wounds. Targeted enrollment is 100 subjects distributed into 4 study cohorts corresponding to the type of wound treated: venous stasis ulcer (20 patients); diabetic foot ulcer \[DFU\] (20 patients); pressure ulcer (20 patients); wounds of various other etiologies (40 patients).


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years of age, inclusive
* Venous stasis ulcer, DFU, pressure ulcer, or other wound sufficiently complex as to be referred to Clinical Investigators at Mission's Wound Care and Bariatric Center
* Patient must be competent to consent for self

Exclusion Criteria:

* Patients younger than 18 years of age
* Women who are pregnant or nursing
* Prisoners
Duloxetine vs. Active Comparator in the Treatment of Patients With Depression

How duloxetine compares to a medication currently available for the treatment of patients diagnosed with depression


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Must be diagnosed with depression
* Must sign informed consent
* Women who can become pregnant must be using birth control

Exclusion Criteria:

* Previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder
* History of substance abuse or dependence in the last year
* Patients who are suicidal
* Frequent or severe allergic reactions with multiple medications
Phase II Study to Evaluate the Efficacy and Safety of GC6101A in Subjects With Gastritis

The purpose of this study is to evaluate the efficacy and safety of the investigational products in the patients with gastritis during their participation in the study.

GC6101A is botanical drug products made from the Lonicerae Flos. Two hundred volunteers will participate in the study, receive 2-week treatment with GC6101A or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age is over 19 years old, men or women
* Patients diagnosed with acute or chronic gastritis by gastroscopy
* Patients with one or more erosions found by gastroscopy
* Signed the informed consent forms

Exclusion Criteria:

* Patients who is impossible to receive gastroscopy
* Patients with peptic ulcer and gastroesophageal reflux disease
* Patients with gastroesophageal surgery and surgery to reduce the secretion of gastric acid (Except for surgery for perforated peptic ulcer and cecectomy)
* Patients with esophageal varix
* Patients with malignant neoplasm of gastrointestinal tract
* Patients with thrombosis or administered with anti-thrombotic drugs
* Patients with consumption coagulopathy
* Patients administered with H2 receptor antagonists, muscarinic receptor antagonists, gastrin receptor antagonist, proton pump inhibitors, prostaglandins or mucosal protective agents prior to study in 2 weeks
* Patient who cannot interrupt steroid, non-steroid anti-inflammatory drugs or aspirin during treatment
* Allergic or hypersensitive to any of the ingredients in the test products
* Pregnant or lactating female
* Patients who have abnormal baseline laboratory test result
* Patients taking other investigational drugs within 30 days prior to the study.
* Patients with Zollinger-Ellison syndrome
* Patients that investigators consider ineligible for this study
Safety and Feasibility of the Application of Thoracic Puncture Tube After Pulmonary Lobectomy

There have been several reports on the feasibility of a no-drain policy after pneumonectomy, but the policy is not widely accepted because silent massive hemorrhage, delayed air leaks, and chylothorax would always be major worries for thoracic surgeons, and all of the researches were retrospective case studies with small sample size and insufficient evidence. Therefore, the purpose of this study is to to evaluate safety and feasibility of an improved policy, the application of a small thoracic puncture tube after pulmonary lobectomy.

This study will be accepted in patients with uniportal VATS(Video-assisted Thoracoscopic Surgery）lobetomy. A randomized controlled study protocol will be used, and The patients will be devided into two groups: experimental group for the application of a small thoracic puncture tube and control group for the application of Combination of the puncture tube and traditional silicone tube. The intraoperative conditions, postoperative recovery and the incidence of perioperative complications will be compared. The safety and feasibility of the application of the small thoracic puncture tube after pulmonary lobectomy will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Age and gender: 18-70 years old, male and female unlimited;
2. Cardiopulmonary function can tolerate operation;
3. Primary non-small cell lung cancer was diagnosed by preoperative or intraoperative pathology. The surgical ranges are uni-portal VATS lobectomy with or without mediastinal lymph node dissection or sampling. In cases with multiple nodules in other lobes of the same side, small wedge resections are allowed;
4. No air leakage was observed intraoperatively. Meanwhile, after operation, there are also no air leakage observed in water seal bottle when patients are changed from lateral decubitus to horizontal position.
5. Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent..

Exclusion Criteria:

1. Patients with a severe emphysema or pulmonary bullae;
2. Patients with a history of chemotherapy or chemo-radiotherapy;
3. Patients with a history of chest surgery;
4. Extensive thoracic adhesion ;
5. A history of serious mental illness;
6. Patients with other conditions considered by the researcher should not participate in the study.
Prevention of Bacteremia Induced by Debridement of Pressure Ulcer

The purpose of this study is to analyse bacteremia induced by debridement of pressure ulcers in patients in the complex nursing department.


Eligibility Criteria:
Inclusion Criteria:

* Patient in the complex nursing department
* With contaminated pressure ulcers
* Going to have a debridement procedure

Exclusion Criteria:

* Penicillin sensitivity
* Bacteremia that does not react to the antibiotic treatment
Nilotinib With Radiation for High Risk Chordoma

The study drug, Nilotinib, is believed to slow down tumor growth by regulating a gene involved in cellular growth of chordoma cells. During this research study, subjects will also receive radiation therapy which is considered a standard treatment for advanced chordomas. It is hoped by adding nilotinib, the benefits of radiation therapy can be enhanced without adding significant toxicities.

The purpose of this research study is to determine the safety of nilotinib when used in combination with radiation therapy, and the highest dose of nilotinib that can be given safely with radiation therapy.

Nilotinib will be taken orally daily in two cycles of 28 days each. Two weeks after taking nilotinib, subjects will begin radiation therapy. Radiation therapy will continue every weekday until Day 56 of the study. If it is determined that the subject's tumor cannot be removed by surgery, an additional 3 weeks of radiation therapy will be applied after Day 56 of the study.

During study visits subjects will have physical exams, routine blood tests, urine and blood clotting tests, and EKGs. Subjects will also have tumor assessment by chest CT and MRI or CT of the tumor at screening, on approximately Day 56 of the study, then every 6 months for one year and then annually thereafter if ther is no disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed chordoma
* Considered to have high risk disease
* Measurable disease
* Life expectancy \> 3 months
* Adequate organ function
* Able to swallow oral capsules

Exclusion Criteria:

* Previous treatment with any other tyrosine kinase inhibitor
* Previous treatment with radiotherapy to the primary or recurrent chordomas
* Impaired cardiac function
* Currently receiving treatment with strong CYP3A4 inhibitors
* Requires anticoagulation with coumadin
* Impaired GI function or GI disease that may significantly alter the absorption of study drug
* Acute or chronic pancreatic disease
* Known cytopathologically confirmed CNS infiltration
* Another primary malignant disease which requires systemic treatment
* Acute or chronic liver disease or severe renal disease considered unrelated to the cancer
* History of significant congenital or acquired bleeding disorder unrelated to cancer
* Major surgery within 4 weeks prior to Day 1 of the study or who have not recovered from prior surgery
* Treatment with other investigational agents within 30 days of Day 1
* History of non-compliance to medical regimens
* Pregnant or breast-feeding
Study to Evaluate Safety and PK/PD of DA-3091 in Healthy Male Subjects

This Phase I clinical study is to evaluate the safety and tolerance of DA-3091 and to characterize the pharmacokinetic/pharmacodynamic of DA-3091 in healthy male subjects

This is a phase I dose escalation study. To meet the clinical objectives, we are using a two-part approach. In part I, 4 subjects are injected 0.5mg dose of DA-3091 or placebo(Single/Subcutaneous Injection). After completion of part I study, we are reporting data about safety to IDMC. In part II, 8 subjects per group are injected 1mg, 2mg, 4mg of DA-3091 or placebo through dose escalating protocol. The ratio of DA-3091 and placebo is 3:1.

Eligibility Criteria:
Inclusion Criteria:

1. Age : 20 \~ 45 years old
2. Healthy Male
3. Body weight : ≥50kg and Ideal body weight ± 20%
4. Informed consent

Exclusion Criteria:

1. Clinically significant medical history
2. Acute or Chronic pancreatitis
3. Clinically significant hypersensitivity of Drugs
4. Clinically significant cutaneous disorder
5. History of administration of exenatide
6. Disorder of blood pressure
7. History of drug abuse
Effect of Early Rehabilitation on Recovery Following Abdominal Hysterectomy

Variety of physical therapy treatments have been used after open abdominal surgery to improve cardiopulmonary and physical function as well as to reduce the incidence of postoperative pulmonary complications. This study intends to determine the effect of early physical therapy interventions on post-operative recovery profile, post-operative ileus and incisional pain following abdominal hysterectomy.

This study is randomized controlled trial which will be conducted at in-patient gynecology department of Pakistan Railway hospital. This study would include total of 42 participants divided into two groups with 21 participants in each group calculated through OpenEpi (CI=95%Power=80%). Individuals will be screened according to inclusion and exclusion criteria and allocated randomly into two groups through sealed envelope method. Experimental group will receive early physical therapy interventions including patient education, ambulation, in-bed exercises, deep breathing exercises, connective tissue manipulation and TENS during the first 3 post-operative days following abdominal hysterectomy. While the control group will receive patient education and early ambulation during the first 3 post-operative days following abdominal hysterectomy.

Post-operative recovery will be assessed on 3rd post-operative day. Intensity of pain will be measured on baseline and 3rd post-operative day. The effect of intervention on post-operative ileus will be measured by monitoring each participant's time to tolerance of oral diet, first passage of stool and flatus

Eligibility Criteria:
Inclusion Criteria:

* open abdominal hysterectomy
* Patient awake and responsive, stable blood pressure, stable heart rate, no dyspnea at rest and pain score \< 8 on visual analogue scale on first post-operative day.
* No limitation on physical activities due to any medical problem or restriction by the physician.

Exclusion Criteria:

* Other hysterectomy procedures i.e. laparoscopic or vaginal hysterectomy.
* Females with diabetes or cancer of metastatic nature.
* Neurological or cognitive deficit.
* Ongoing respiratory problem prior to initiation of physical therapy session.
* Medical recommendation not to participate in early active rehabilitation
Incorporation of Protein Induced by Vitamin K Absence or Antagonist-II Into Transplant Criteria Expands Beneficiaries of Liver Transplantation for Hepatocellular Carcinoma

This is a multi-center study in China to investigate the role of PIVKA-II in HCC recipient selection and prognostic stratification by analyzing the data of 522 recipients with HCC registered in the China Liver Transplant Registry.


Eligibility Criteria:
Inclusion Criteria:

* The HCC patients received LT with pre-operative PIVKA-II records performed from January 2015 to December 2020, whose clinicopathological data were registered in the CLTR.

Exclusion Criteria:

* (1) patients who received split LT or simultaneous transplantation, (2) patients who received re-transplantation, (3) patients with macroscopic portal vein tumor thrombosis or other macrovascular invasion, (4) patients with incomplete follow-up or incomplete important parameters records.
Managing Temporomandibular Disorder (TMD) Symptoms

The purpose of this study is to determine whether treatments targeted to the hormonal factors and the cyclicity of TMD symptoms associated with the menstrual cycle are more effective in relieving TMD pain and symptoms than standard self management treatment.

Temporomandibular disorders (TMD) are a group of painful conditions involving the muscles of mastication and the temporomandibular joint. These pain problems are about twice as common in women as in men in the community, and prevalence peaks during the reproductive years. The etiology of TMD pain is unknown, but psychological stress, depression and the presence of other somatic complaints have been shown to influence the course of these disorders. Prior research suggests that female reproductive hormones may also influence TMD pain. Specifically, normally cycling women with TMD experience rising levels of TMD pain pre-menstrually during a time of precipitous drop in estrogen and show peak TMD pain during menses. Interestingly, a secondary peak of TMD pain occurs at about the time of ovulation, another phase corresponding to rapid estrogen change. These data demonstrate a systematic relationship between levels of TMD pain and phases of the menstrual cycle. The proposed clinical trial will manipulate the behavioral and hormonal factors that are hypothesized to influence TMD pain, comparing the effects of:

* a continuous oral contraceptive intervention designed to suppress menses and stabilize the hormonal environment;
* a self-management intervention focused on and timed to the chronobiology of TMD symptoms across the menstrual cycle; and
* a usual self-management intervention not timed to biological events. The aims of this clinical trial are to shed light on the mechanisms underlying the cyclic nature of TMD pain and symptoms in women, as well as to determine which treatment modality results in the greatest improvement in TMD pain and symptoms.

Eligibility Criteria:
Inclusion Criteria:

* TMD Pain Diagnosis as determined by enrollment exam at the University of Washington
* Menstruate on a regular basis
* Not planning to become pregnant during the next 6 months

Exclusion Criteria:

* Drug or alcohol abuse
* Current smoker and 35 years of age at any time during the study
* Live further than 1 hour driving distance from the University of Washington, Seattle campus
* Psychiatric disability
Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy

RATIONALE: Collecting and storing samples of blood and urine 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 biomarkers in patients undergoing transrectal ultrasound prostate biopsy.

OBJECTIVES:

Primary

* Identify unique proteins or peptides that are associated with prostate cancer by comparing the proteomic or metabolomic analysis of serum, plasma, and urine from patients with histological evidence of prostate cancer to those without prostate cancer (after transrectal ultrasound prostatic biopsy).

Secondary

* Collect seminal fluid from a subset of patients to test the hypothesis that the fluid collected from the "target organ of injury" in prostate cancer will have a higher signal of proteins/peptides that are different from those without cancer and may help guide the identification of these differences in the serum, plasma, and urine.

OUTLINE: This is a pilot study.

Patients undergo collection of serum, plasma, and urine for biomarker/laboratory analysis. Samples are examined by proteomic/metabolomic analysis (by mass spectrometry) and immunoassays. Patients then undergo a transrectal ultrasonography prostatic biopsy.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Indication for a transrectal ultrasonography prostatic biopsy (as part of normal patient care) due to elevated prostate-specific antigen, or abnormal digital rectal examination, or surveillance for prostate cancer

PATIENT CHARACTERISTICS:

* No prior or other concurrent malignancy except for curatively treated basal cell carcinoma of the skin
* No serious medical or psychiatric illness that would preclude informed consent
* No concurrent acute illness

PRIOR CONCURRENT THERAPY:

* No participation in another clinical trial within the past 30 days
* No more than one enrollment into this study
A Study of ARRY-380 in Patients With Advanced HER2+ Cancer

This is a Phase 1 study during which patients with advanced HER2+ solid malignancies or HER2+ metastatic breast cancer will receive investigational study drug ARRY-380.

This study has 2 parts. In the first part, patients with advanced HER2+ solid malignancies, who have already received at least one previous standard therapy, will receive increasing doses of study drug in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Completed).

In the second part of this study, patients with HER2+ metastatic breast cancer, who have already received at least one previous standard therapy, will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 20 patients from the US will be enrolled in Part 2 (Active, not recruiting).


Eligibility Criteria:
Key Inclusion Criteria (Part 1 and Part 2):

* Histological or cytological evidence of HER2+ cancer (Part 1) or HER2+ metastatic breast cancer (Part 2).
* Patients should have received at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standard therapy available, or choose not to pursue standard therapy (patients with HER2+ breast cancer and with clinical indication for trastuzumab or lapatinib should have received prior therapy with trastuzumab and lapatinib, if available).
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0 and 2.
* Additional criteria exist.

Key Exclusion Criteria (Part 1 and Part 2):

* Uncontrolled or symptomatic brain metastases (patients may be considered adequately controlled if on a stable steroid dose for at least 30 days).
* Treatment with an investigational medicinal product or device within 30 days prior to first dose of study drug.
* Radiotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites).
* Chemotherapy within 21 days prior to first dose of study drug.
* Major surgery within 30 days prior to first dose of study drug.
* Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
* Additional criteria exist.