cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Placebo-controlled, Double Blind Trial to Investigate Whether Vitamin K2 Can Influence Arterial Calcification in Patients With Type 2 Diabetes

Arterial calcification is an independent predictor of coronary events associated with a 3-4 fold increased risk of cardiovascular events. Currently, no effective intervention exists to reduce arterial calcification. However, recent studies showed that vitamin K may reduce ongoing calcium deposition in the arteries, and thereby inhibit arterial calcification.

The primary objective is to determine if MK-7 supplementation leads to stabilization or attenuation of ongoing calcium deposition in the femoral artery as quantified by 18F-NaF PET/CT imaging in patients with type 2 diabetes and arterial disease.


Eligibility Criteria:
Inclusion Criteria:

* Middle aged men and women, ≥ 40 years.
* Diagnosed with type 2 diabetes.
* Presence of arterial diseases, based on an Ankle Brachial Index (ABI) \<0.9 and/or diagnosed with arterial diseases by physician.
* ABI\<0.9
* Written informed consent.

Exclusion Criteria:

* Subjects participate in another intervention research or study using imaging.
* Contra-indication for undergoing18F-NaF PET/CT scan (claustrophobia, pregnancy, breastfeeding).
* Subject underwent amputation of the lower extremities (above the knee).
* Using vitamin K antagonists.
* Known coagulation problems (history of Venous Thrombo Embolism).
* Using vitamin supplements that contain vitamin K, or unwilling to stop two weeks before randomisation.
* A mean vitamin K2 intake ≥120 microgram/day measured with a questionnaire.
* Natto or goose liver consumers.
* Low kidney function (eGFR\<30).
Trial of Adjuvant Chemotherapy for Gastric Cancer

This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine in resected advanced gastric cancer.

Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.

This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with early mitomycin administration and adding cisplatin to prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven gastric adenocarcinoma
* Grossly serosa invasion of primary tumor is suspicious
* Curative resection was done
* Stage II, IIIA, IIIB, IV (including T4, lesions or N3, but excluding M1 lymph node metastasis)
* Age: 18-69 years old
* Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2
* Adequate bone marrow function (white blood cell counts ≥ 4,000/ul, platelet count ≥ 100,000/ul, hemoglobin ≥ 10 g/dl)
* Adequate renal function (serum creatinine≤ 1.5)
* Adequate liver function (serum bilirubin ≤1.5 mg/dl, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x normal upper limit)
* Written informed consent was signed by the patient

Exclusion Criteria:

* Previous chemotherapy or radiotherapy
* Active ongoing infection which antibiotic treatment is needed
* Pregnant or lactating women
* Psychosis or convulsion disorder
* Ascites in preoperative abdomen computed tomography (CT)
* Systemic disease which interfere the administration of chemotherapy
* Postoperative pathologic stage IA, IB
* Postoperative pathology indicates that resection margin is involved
* Previous history of other malignancy except cured non-malignant skin cancer and uterine cervical cancer in situ
Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development

Introduction:

Hypertensive disorders during pregnancy are an important issue in global public health. It is current the leading cause of maternal mortality in Brazil.

Objective:

To assess the effect of physical exercise using stationary bicycle through blood pressure and heart rate measurements, incidence of pre-eclampsia and quality of life survey in pregnant women with chronic high blood pressure, previous preeclampsia pregnancies or both factors associated comparing to a group with no intervention. Verify the type of births, maternal and perinatal outcomes in both groups. Methodology: This randomized clinical trial enrolled pregnant women presenting chronic hih blood pressure, previous pre-eclampsia experience or both. Women from 12 to 20 gestational weeks were selected from the prenatal outpatient clinic and randomly allocated to the study or non-interventional group. Women at the study group performed physical exercise using stationary bicycle (horizontal bench model) during 20 minutes, once a week. The heart rate was maintained at 20% above resting heart rate and up to 140 bpm. Blood pressure and heart rate measurements were evaluated before and after exercise. The non-intervention group followed regular prenatal routine with weekly returns for heart rate and blood pressure measurements. Both groups fulfilled the quality of life survey (SF-36 questionnaire) at three times: between 12 and 20 weeks; 28 and 32 weeks and 36 and 41 weeks of gestation. After that data of parturition will be analyzed to compare the incidence of pre-eclampsia, types of birth, maternal and perinatal outcomes.

Significance was assumed as p\<.5%.

Eligibility Criteria:
Inclusion Criteria:

* pregnant with 12 to 20 weeks gestational
* have chronic blood pressure, previous pre-eclampsia or both
* able to perform a exercise

Exclusion Criteria:

* multiple pregnancy
* Systemic lupus erythematosus
* heart disease
* neurological disease
* renal failure
* persistent vaginal bleeding
* isthmic-cervical insufficiency
Study of Fludarabine With Pegylated Liposomal Doxorubicin Versus Pegylated Liposomal Doxorubicin Alone In Patients With Platinum Resistant/Refractory Ovarian Cancer

The purpose of the study is to evaluate the efficacy and toxicity of fludarabine with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.

Ovarian cancer is the leading cause of death for patients with gynecologic malignancies. Approximately 75% of patients are diagnosed at an advanced stage will eventually experience disease recurrence. The overall response rates of second-line chemotherapy for recurrent ovarian cancer are only 20-27%. The 5-year overall survival rates are less than 20%. Therefore, it is important to seek alternative agent that can improve the outcome. Fludarabine is a purine nucleoside analog prodrug that upon phosphorylation is toxic to dividing and quiescent lymphocytes and monocytes, exerting its effects through DNA synthesis interference and apoptosis. The preclinical studies suggest fludarabine may be effective in other cancers such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and safety of the study drug fludarabine combined with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant or refractory ovarian cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or pathologically confirmed diagnosis of epithelial carcinoma of the ovary.
* Platinum resistant or refractory ovarian cancer
* At least treated with one line of platinum-based chemotherapy
* Female, age ≥18 years and ≤70 years, signed informed consent.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 version
* Patients must have a life expectancy of at least 3 months.
* Patients must have adequate organ function as defined by the following criteria:

  * White blood cell count ≥ 3 x 10\^9/L, Absolute neutrophil count (ANC) (≥ 1.0 x 10\^9/L), Hemoglobin of ≥ 80 g/L, Platelets ≥ 80 x 10\^9/L
  * Total bilirubin ≤ 1 x upper limit of normal (ULN), AST and ALT ≤ 2.5 x ULN
  * Serum creatinine ≤ 1 x ULN
* Symptomatic central nervous system (CNS) metastasis

Exclusion Critera:

* Has known allergies to any of the excipients.
* Prior treatment with adriamycin or other anthracycline at cumulative doses greater than 550 mg/m2 after 6 cycles of pegylated liposomal doxorubicin
* LVEF (left ventricular ejection fraction) \<50%
* Had disease recurrence/progression within 6 months after the administration of doxorubicin chemotherapy
* History of myocardial infarction, or unstable angina, or New York Heart Association (NYHA) Grade III-IV within 6 months prior to Day 1.
* Known significant chronic liver disease, such as cirrhosis or active hepatitis
* Uncontrollable active infection
Baduanjin Sequential Therapy and Cardiac Function of AMI With Reduced EF After PCI

Acute myocardial infarction (AMI) is one of the leading causes of death around the world, with the potential for substantial morbidity and mortality. The increasing evidence indicates that exercise training has beneficial effects on LV remodelling in post-MI patients with greater benefits occurring when training earlier following MI, among which the earliest time for rehabilitation is one week after myocardial infarction. However, the effect of Baduanjin sequential therapy for patients after one week of AMI has yet to be assessed. Therefore, the aim of this study is to assess the impact of Baduanjin sequential therapy on cardiac and physical function in patients with AMI and reduced ejection fraction after primary PCI.


Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction undergoing primary percutaneous coronary intervention;
* Aged 18 years or over and under 80 years;
* 35% \< LVEF \< 50% and LV \< 65mm;
* With informed consents

Exclusion Criteria:

* Severe symptomatic congestive heart failure (KILLIP cardiac function class III-IV);
* Malignant arrhythmias (ventricular fibrillation, ventricular tachycardia, frequent multiple source ventricular premature);
* Uncontrolled hypertension (systolic blood pressure greater than 160mmhg, diastolic blood pressure greater than 100mmhg);
* Life-threatening diseases with limited life expectancy \<6 months;
* Inability or difficulty to exercise;
* Participation in other clinical trials
Impact of COVID-19 Pandemic on Headache Evaluations in the Pediatric Emergency Department

Background: To evaluate the impact of COVID-19 on evaluations in the pediatric emergency department (ED) because of headache as main symptom.

Methods: Number and clinical features of patients evaluated in the pediatric ED of a single site in Milan,Italy, were collected between January 2017 and January 2022. The impact of COVID-19 on evaluation rates was quantified by using the incidence rate ratio (IRR) and 95% confidence intervals (CI) between the pandemic (March 2020 to January 2022) and the prepandemic period (January 2017 to February 2020).


Eligibility Criteria:
Inclusion Criteria:

* range of age: 2 - 18 years
* sex: all
* headache as main symptom

Exclusion Criteria:

* headache in the context of head trauma, because of different diagnostic-care in Pediatric Emergency Department
Assisting Obsessive Compulsive Disorder (OCD) Patients With Discontinuing Long-term Serotonin Reuptake Inhibitors (SRIs)

This study will address questions of fundamental clinical significance including: (1) whether OCD patients maintained on long term SRIs can be discontinued without symptom exacerbation, (2) whether trans-diagnostic cognitive-behavioral treatment will reduce worsening following discontinuation compared to Taper and Monitoring, and (3) whether predictors of successful SRI discontinuation can be identified.


Eligibility Criteria:
Inclusion Criteria:

1. 18 or older
2. Presence of mild to moderate OCD symptoms
3. Patient's treating clinician agrees that SRI discontinuation is clinically appropriate
4. Adequate trial of SRI (≥10 weeks) in the current treatment episode
5. Maintenance on SRI dose that has not increased due to significant clinical worsening in the two years prior to enrollment
6. English speaking

Exclusion Criteria:

1. Clinically significant suicidality or a suicide attempt within the past year
2. Presence of any clinical features warranting a higher level of care (partial or inpatient hospitalization)
3. Current or recent (past 6 months) alcohol or drug dependence or abuse
4. Current or past psychotic disorder or bipolar disorder
5. Moderate to severe depression, as indicated by a Hamilton Rating Scale for Depression (HRSD) (17-item) ≥ 14 or recent major depressive episode (past 6 months)
6. History of severe OCD (YBOCS ≥ 28)
7. Prior adverse experience with SRI discontinuation
8. Primary compulsive hoarding
9. Cognitive impairment that would interfere with study participation
10. Concomitant psychosocial treatment w/ proven efficacy in the treatment of OCD
11. Previous adequate trial of exposure-based treatment (e.g., history of 12 or more sessions) in past 5 years
12. Use of non-SRI psychotropic medications for OCD in the 3 months prior to enrollment.
Light Therapy for Obsessive-compulsive Disorder (OCD)

The goal of this clinical trial is to test whether light therapy is effective for reducing symptoms in young adults with OCD and late bedtimes (1am or later). The main question\[s\] it aims to answer are:

Does light therapy reduce OCD symptoms? Does light therapy advance the circadian clock? If there is a comparison group: Researchers will compare a higher dose of light therapy to a lower dose to see if dose amount affects symptom reduction.

Participants will asked to:

1. Wear light therapy glasses for 1 hour each morning and complete a daily light therapy log for 5 weeks
2. Track their sleep every day with a wearable monitor and an electronic sleep diary for 5 weeks
3. Complete a 1-time assessment of sensitivity to light exposure
4. Complete self-report measures of OCD 4 times/day at baseline (2 weeks), mid-treatment (1 week), and end of treatment (1 week)


Eligibility Criteria:
Inclusion Criteria:

1. Primary DSM-5 OCD diagnosis
2. Bedtime 0100 or later
3. Age 18-35
4. English speaking

Exclusion Criteria:

1. Subjects must not be currently participating in another research study that would influence their participation in our study.
2. Diagnostic status
3. Treatment status
4. Night shift work or travel more than 1 time zone outside of Central Standard Time (CST) in the past month
5. Pregnancy status
6. Medication status
7. Regular nicotine or marijuana use
Oxytocin Antagonist in Patients With Repeated Failure of Implantation

In this study the investigators compare the usual way of embryo transfer (without medication) with an embryo transfer while administering oxytocine antagonist. This to improve implantation and increase the pregnancy rate.


Eligibility Criteria:
Inclusion Criteria:

* IVF/ ICSI patients below 38 years
* 2e to 6e IVF-cycle

Exclusion Criteria:

* patients with endocrinological diseases or problems
Bacterial Infections in Patients with Cirrhosis in Argentina: Clinical and Microbiological Characteristics

In recent years, there has been an increasing prevalence of bacterial infections caused by multiresistant and extremely resistant organisms in patients with cirrhosis. These infections are associated with a worse prognosis, generate difficulties in the management of the patient during hospitalization and increase health costs.

The main objective of this project is to estimate the prevalence of infections by multiresistant bacteria in patients with cirrhosis. Additionally, the prevalence of other antibiotic resistance patterns and morbi-mortality in the study population will be evaluated.

For these purposes, a multicenter prospective cohort study will be carried out, including patients with cirrhosis who present bacterial infections at the time of admission, or during hospitalization.

Performing a study in Argentina on the clinical and microbiological characteristics of bacterial infections in patients with cirrhosis could be very useful to develop new strategies for prevention and treatment of this severe complication.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis
* Patients older than 17 years.
* Patients who are hospitalized for bacterial infections, or who develop bacterial infections while hospitalized

Exclusion Criteria:

• Refusal to participate in the informed consent process
Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography

1. To asses regional RV function in patients presented with acute pulmonary embolism using speckle tracking echocardiography
2. To evaluate its relationship to long term mortality.

Pulmonary embolism (PE) is the third most common cardiovascular cause of death after myocardial infarction and stroke . The incidence of PE has been increasing ,with significant associated mortality; a recent registry of PE patients reported a mortality rate \> 10% at 30 days. There are a number of emerging contemporary PE therapies, including thrombolysis, catheter intervention and surgery. Early and accurate identification of PE in patients is therefore critical. A transthoracic echocardiogram (TTE) may help when there is a clinical suspicion for PE, and its use in confirmed PE is widely recommended . A number of right atrial (RA) and right ventricular (RV) parameters have been shown to be abnormal in patients with PE . In addition, RA and RV enlargement portends a worse prognosis in these patients .

Eligibility Criteria:
Inclusion Criteria:

1. clinical diagnosis of acute pulmonary embolism
2. Age: 20 - 70 years.

Exclusion Criteria:

1. coronary artery disease
2. patient of Atrial fibrillation.
3. Patient of impaired RV function due to chest disease (Cor-pulmonale)
4. patient with impaired Ejection fraction (EF) \<50%
5. Moderate to severe valvular heart disease.
6. Atrio-ventricular conduction disturbance.
7. Poor echogenicity
AI-Enhanced Analysis of Breast Density and Background Parenchymal Enhancement (BPE)

This study expands upon previous research investigating the correlation between breast density, Background Parenchymal Enhancement (BPE), and age in contrast-enhanced mammography (CEM). By integrating Artificial Intelligence (AI) methodologies, including Artificial Neural Networks (ANNs) and deep learning models, the study aims to optimize the accuracy of predictions and validate prior findings obtained through multiple linear regression.


Eligibility Criteria:
Patients who underwent CEM, mammography, and ultrasound between May 2022 and June 2023.

Availability of BPE assessment, BI-RADS density classification, and age data.

Complete dataset available for statistical and AI-based analysis.

Exclusion Criteria:

Patients with prior breast cancer treatment that could alter BPE.

Incomplete imaging or missing classification data.

Contraindications to contrast-enhanced imaging.
Evaluation of Healing at Molar Extraction Sites With and Without Ridge Preservation

Following tooth extraction ridge preservation procedure have been suggested to limit bone resorptive dimensional changes to facilitate prospective implant placement. While this is particularly true for anterior teeth, no evidence is available to establish clinical guidelines in posterior sites, i.e. following molar extraction.

This research project will answer the following question:

What are the dimensional changes of the hard and soft tissues encountered following molar extractions with and without ridge preservation?


Eligibility Criteria:
Inclusion Criteria:

* Patients will be included in this study if they qualify the following inclusion criteria:

  * One molar tooth that has been identified by dental faculty as requiring a single tooth extraction
  * A dental implant is indicated and treatment planned to replace the missing molar tooth
  * Have adequate restorative space for a dental implant-retained restoration
  * Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.

Exclusion Criteria:

* Obvious exclusions are patients who do not meet all the inclusion criteria or who will not cooperate with the follow-up schedule.
* Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
* Pregnant women or women intending to become pregnant during the study period. As standard practice prior to dental surgery, females of child-bearing age are asked verbally if there is any possibility that they are pregnant. If not, we proceed with surgery and no pregnancy test is done. If the woman states that there is a possibility that she is pregnant, we do a urine pregnancy test to rule pregnancy in or out. So use of the urine pregnancy test is only done if she says she may be pregnant. \[If needed: An over-the-counter urine pregnancy test will be provided to female subjects in the graduate periodontics clinic of UTHSCSA. Patients will be allowed access to a private restroom and the results of the tests will be read by one of the named investigators. Only those with a negative pre-operative pregnancy test will be eligible for the study.\] Female patients who have undergone a hysterectomy, tubal ligation or menopause will be excluded from pregnancy testing.
* Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
* Clinical and/or radiographic determinations which will preclude inclusion in this study are:

  * Active localized or systemic infection other than periodontitis.
  * Untreated periodontal diseases
  * Inadequate bone dimensions or restorative space dimensions to place a dental implant
  * Presence of a disease entity, medical condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, or autoimmune diseases.
  * Positive medical history of endocarditis following oral or dental surgery.