cyrilzakka/clinical-trials huggingface dataset:
DCVAC/OvCa and Standard of Care (SoC) in Relapsed Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

Multi-center, phase III trial of DCVAC/OvCa added to standard of care treatments for relapsed ovarian cancer. Patients will receive study treatment until all doses are administered, or other criteria are met.

All patients who meet entry criteria will be randomized, and will undergo a leukapheresis procedure. During the Induction period, all patients will receive DCVAC/OvCa or placebo (study treatment) with concurrent standard-of-care platinum-based chemotherapy, with or without use of bevacizumab. In the Maintenance period, patients will continue treatment with study treatment in combination with bevacizumab, a poly (ADP-ribose) polymerase inhibitor (PARPi) or best supportive care only. Study treatment will continue irrespective of disease progression

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed high-grade serous or endometrioid carcinoma of the ovary, peritoneum or fallopian tube.
* Without disease progression during preceding platinum-based chemotherapy
* Platinum-sensitive patients defined as Platinum-Free Interval of more than 6 months between the end of the last cycle of platinum-based chemotherapy and radiologic evidence of progression.
* First relapse identified by the criteria above up to 28 days prior to study randomization
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Known BRCA (breast cancer susceptibility gene) mutation status before randomization
* Patient is intended to be treated with bevacizumab, best supportive care (BSC) only or PARPi

Exclusion Criteria:

* Tumor-specific: any other histology sub-type that is not high grade serous or endometrioid, however a combination of these is allowed
* Disease Treatment history: started or ongoing systemic treatment for current relapse of Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer before signing informed consent form (ICF), concomitant use of anti-neoplastic anti- hormonal therapy
* Intention to treat with intra-peritoneal chemotherapy
Gastrointestinal Postoperative Early Enteral Nutrition: Immuno-enhanced Versus Standard Early Enteral Nutrition

Patients with gastrointestinal(GI) malignancy usually suffer from malnutrition and suppressed immune function, which might be worsened by major elective surgery.Enteral nutrition has been emphasized for patients with GI malignancy during the perioperative period to accelerate bowel function recovery, and improve nitrogen balance and immune response while reducing postoperative complications and hospitalization time.Early enteral nutrition(EEN) can promote the postoperative recovery of GI function and has been considered to have other advantages such as the reduction of medical cost and maintenance of intestinal barrier function. Immunonutrition containing special compounds like omega-3-unsaturated fatty acids has been put forward to modulate the immune response and improve the immune function in patients with cancer, which may have an better effect on the immune system than standard enteral nutrition. However, studies on immuno-enhanced early enteral nutrition after a resectable GI malignancy surgery are scarce.

The aim of this study was to determine whether immuno-enhanced early enteral nutrition(IEEN) is more effective than standard early enteral nutrition(SEEN) on nutritional status, immune function, surgical outcomes,time to adjuvant chemotherapy and days of hospitalization after laparoscopic GI surgery.


Eligibility Criteria:
Inclusion Criteria:

* Resectable gastric cancer by laparoscope
* Resectable colorectal cancer laparoscope
* Resectable gastrointestinal interstitialoma by laparoscope

Exclusion Criteria:

* Locally unresectable tumor
* Metastatic tumor
* Preoperative total parenteral or enteral nutrition
* Lack of the patient's consent for the trial participation
* Previous gastrointestinal resection
Antibiotics in Chronic Obstructive Pulmonary Disease (COPD)

It is not clear whether antibiotic therapy is needed in patients with mild to moderate exacerbation of chronic obstructive lung disease. The aim of the study is to compare the effect of 1 day of treatment with 6 days of treatment in patients who are admitted to hospital and being clinical stable (as judged by their physician) 24 hours after hospitalization


Eligibility Criteria:
Inclusion Criteria:

* Age above 50 years
* History of smoking
* History of COPD
* Antibiotics for 24 hours
* At least 2 of the following: dyspnoea, coughing with sputum, and sputum with purulence
* Informed consent

Exclusion Criteria:

* Pneumonia
* Antibiotics for more than 36 hours
* Antibiotics for other infection
* Prednisolone, more than 0.5 mg/kg body weight/24 hours for more than 3 days
* Malignancy
* Other pulmonary disease
* Immune deficiency
* Not able to tolerate doxycycline
* Severe heart, liver or kidney disease
* Epilepsia
* Not stable 24 hours after hospital admission
* Need for assisted ventilation
Evaluate the Effect of Dietary Supplement on Muscle Mass and Physical Performance for Over 50 Years Old People

To assess the ability and safety profile of dietary supplement to augment lean body mass, muscle strength, and physical performance among people aged 50 years and older

In light of the rapidly expanding aging population, sarcopenia and related disorders are emerging as a major public health problem of the 21st century.Sponsor has produced a dietary supplement, which has been on market in Taiwan. The proposed study is conducted to confirm whether the amino acid supplementation is able to enhance the magnitude of gain in lean body mass and muscle strength in middle-aged and older adults with muscle loss or sarcopenia undergoing exercise training.

Eligibility Criteria:
Main Inclusion Criteria:

1. Male or female aged 50 years or older.
2. Subjects who has muscle loss or at risk of muscle loss, with symptoms of reduced physical activities, reduced gait speed, exhaustion, or had tumbled/ fallen within past year
3. Willing to comply with study procedures and follow-ups
4. Provide written consent

Main Exclusion Criteria:

1. Gait speed ≤ 0.3 m/sec
2. Any disease that interferes with limb function, including:

   1. Limb fracture within past 6 months
   2. Severe knee, hip, or arm arthritis
   3. As judged by the investigator, disorder of nervous system (i.e., stroke, severe spinal stenosis, peripheral neuropathy, and Parkinson's disease) with poor control
   4. Intermittent claudication due to peripheral artery disease
3. As judged by the investigator, mental disorders (i.e., confirmed diagnosis of dementia) with poor control
4. Cardiopulmonary disease with poor control judged by the investigator
5. Malignancy with poor control judged by the investigator
6. Subjects claim to have chronic renal disease, defined as kidney damage or GFR \< 30 mL/min/1.73 m2 for at least 3 months
7. Severe visual and hearing impairment that becomes barrier to communication
8. Subjects have taken any hormone replacement therapy within 3 months prior to study enrollment, or plans to begin hormone replacement therapy at any time during the study
9. Subjects with known poorly controlled diabetes (HbA1c \> 9.0%), hyperthyroidism or thyroid insufficiency, Cushing's syndrome, or adrenal insufficiency
10. Subjects with known milk allergy or lactose intolerance
11. Other conditions that investigator considers subject is ineligible to participate in the study
Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese Patients

Clinical Study to Evaluate the Performance of Magna Ease Heart Valve in Chinese patients.


Eligibility Criteria:
Inclusion Criteria:

* The patients who implanted with Magna Ease Heart Valve (Type:7300TFX and 3300TFX) in Fuwai Hospital in China.
* The patients agree to sign the inform consent form (ICF).

Exclusion Criteria:

* No specific exclusion criteria.
Osteoporosis and Fragility Fractures Among SLE Patients. (FRAIL Trial)

The trial is designed to evaluate prevalence of fragility fracture, their impact on quality of life of SLE patients and disease or treatment variables such as steroids dosage or use of specific drugs like hydroxychloroquine, DMARDs or belimumab. Patients will perform DXA evaluation, blood tests and PROs questionnaires. Moreover, the investigators want to correlate those variables to bone turnover markers and bone metabolism modulators. A secondary aim is also to assess the fracture risk of those patients as described by FRAX and DEFRA tools.


Eligibility Criteria:
Inclusion Criteria:

* SLE fulfilling 2019 ACR/EULAR or 2012 SLICC criteria
* willing to perform DXA/ x-Ray investigation (common clinical practice)
* willing to donate blood sample
* willing to complete questionnaires
* the patients should be in a stable disease activity.

Exclusion Criteria:

* Uncontrolled endocrinological disease.
* metabolic bone disease other than osteoporosis ( e.g. Paget disease).
* celiac disease, inflammatory bowel disease or pancreatic exocrine deficiency resulting in malabsorption
* patients lacking medication history information (SLE and bone related medications).
* Have any other clinically significant abnormal laboratory value in the opinion of the investigator
* Have any intercurrent significant medical illness that the investigator considers would make the candidate unsuitable for the study.
* The patients shouldn't be enrolled during a moderate to severe flare of disease requiring an escalation of therapy ( especially glucocorticoid) - no new BILAG A or B in the last 3 months.
* Pregnant patients or during the first year after child birth.
LIdocaine veRsus Sufentanil Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass

Since the 90's the concept of morphine sparing and morphine free anaesthesia (OFA) has progressively developed in non-cardiac surgery. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic modifications does not translate into a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, the sympathetic reaction and the inflammatory reaction can be controlled by other therapeutic classes than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In this hypothesis, OFA is more and more practiced in various situations without the real impact in terms of clinical benefit being clearly demonstrated. In cardiac surgery, some centers practice OFA with various protocols.The purpose of this work is to retrospectively evaluate over a defined period the incidence of postoperative complications, length of stay in the ICU/hospital, and death rate between patients managed with/without OFA based on lidocaine.


Eligibility Criteria:
Inclusion Criteria:

age over 18 years Cardiac surgery with cardiopulmonary bypass performed between January 2019 and June 2021

Exclusion Criteria:

LVAD Heart transplantation Incomplete data in relation to outcomes
Matrix Metalloproteinases and Diabetic Nephropathy

Matrix metalloproteinases (MMPs) are a family of protein-degrading enzymes that are involved in the breakdown and remodeling of many tissues and organs. Abnormal activity of these enzymes has been implicated in many disease processes including rheumatoid arthritis, dental disease and metastatic cancer. Recent studies also suggest that elevations in blood sugar may abnormally effect MMP enzyme activity. Decreased activity of some of these MMP enzymes may be a partial cause of the abnormal enlargement of the kidney (renal hypertrophy) seen at the start of diabetic kidney disease (nephropathy). Preliminary clinical data from our laboratory confirm that children with newly diagnosed type 1 diabetes mellitus (DM) have lower blood levels of some of these enzymes at the time of very high blood sugar readings. However, these enzyme levels become normal again as blood sugar levels improve with insulin treatment. In the present study, we propose to investigate the hypothesis that MMPs are involved in the cause of diabetic kidney disease by measuring concentrations of specific MMPs and some related proteins in the blood and urine of patients with type 1 DM who are between the ages of 14-40 years. We will enroll some patients who are recently diagnosed with diabetes, some who have had diabetes for several years, but without signs of kidney disease, and some with long-term diabetes and various degrees of kidney disease. Continuous Subcutaneous Glucose Monitoring, conducted for 3-4 days, will also be provided as a part of this study, to determine how different levels of blood sugar control might relate to different levels of MMP enzyme activity in the blood. We anticipate that this study will help to establish a link between abnormal MMP activity and the cause of nephropathy in type 1 DM, allowing scientists to design better therapies for the prevention and treatment of diabetes-related kidney problems.


Eligibility Criteria:
Type 1 Diabetes with or without kidney disease and past puberty.
Effects of Hypertonic Saline Solution (NACL 3%+NAHCO3) on Nasal Inflammation in Children With AR. RinASol- Pilot Study

The main objective of RinASol project is to assess in patients with seasonal Allergic Rhinitis the effect of hypertonic saline solution NACL 3%+NAHCO3 vs the effect of standard saline solution on nasal inflammation by means of nasal cytology.

The secondary objective is the symptom score assessment by T5SS Questionnaire (Total Symptom Score 5)


Eligibility Criteria:
Inclusion Criteria:

* Clinical history of Allergic Rhinitis (for at least 1 year)
* 6 years old ≤ children age ≤ 14 years old
* Total Symptom Score 5: \>5 in the last 4 days before screening. Exclusion Criteria
* Signs of acute infections of upper and lower respiratory tract.
* Metabolic, immunological, systemic diseases
* Respiratory tract deformity
* Systemic/Topical therapies with antibiotics or corticosteroids in the previous 30 days.
* Active smoker.
Decitabine Versus Supportive Care in Adults With Advanced-stage MDS

To compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (MDS)

This experimental (investigational) study is intended to answer the question of whether decitabine is any better than supportive care alone in delaying progression (worsening) of the disease, prolonging survival or improving the overall quality of life for MDS patients who are not candidates for bone marrow transplant (BMT).

Eligibility Criteria:
Inclusion:

* MDS (de novo or secondary) fitting any of the recognized French-American-British, FAB, classifications or chronic myelomonocytic leukemia (CMML) with WBC \< 12,000/mm3, AND International Prognostic Scoring System (IPSS) \>/= 0.5 as determined by CBC, bone marrow assessment and bone marrow cytogenetics within 30 days of randomization
* 18 years or older
* Female patients of child-bearing potential must have a negative serum hCG within 24 hours prior to randomization, must practice a medically approved method of birth control for the past 30 days, and agree to continue this practice for the trial duration and must not be breast-feeding
* ECOG or WHO performance status of 0-2
* Written informed consent
* Normal renal and hepatic function (creatinine \</= 2 mg/dL, bilirubin \</= 1.5 mg/dL, SGPT \</= 2 times the upper limit of normal range)

Exclusion:

* Acute Myeloid Leukemia (AML) (\>/=30% bone marrow blasts) or other progressive malignant disease
* Patients must have recovered from the toxic effects of prior therapy and must be off all chemotherapy for a minimum of 4 weeks prior to study entry to the protocol (a minimum of six weeks for prior nitrosoureas and bone marrow transplantation)
* Ongoing treatment with androgenic hormones, danazol, colony-stimulating factors, or other agents used to treat MDS within 7 days of study initiation.
* Administration of any investigational agent within the 30 days preceding study initiation.
* Uncontrolled cardiac disease or congestive heart failure
* Uncontrolled restrictive or obstructive pulmonary disease
* Active viral or bacterial infection
* Superimposed autoimmune hemolytic anemia or thrombocytopenia
* Known positive serology for HIV
* Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study.
Small Bowel Endoscopic Evaluation in Familial Adenomatous Polyposis (FAP)

Background and study aim The relative risks of duodenal adenocarcinoma and ampullary carcinoma in Familial Adenomatous Polyposis (FAP) have been estimated 100 to 330 times higher than in general population. However risk factors, including a genotype-phenotype association for duodenal cancer in FAP has not been fully understood. The aim of this study is to determine risk factors associated with the development of advanced duodenal polyposis and ampullary adenomas in colectomized patients with FAP.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Familial Adenomatous Polyposis with colectomy, or scheduled for surgery.

Exclusion Criteria:

* Pregnancy, lactation
Preventing Depression Relapse With Mindfulness-Based Cognitive Therapy

This study will determine the effectiveness of mindfulness-based cognitive therapy (MBCT) in preventing depression relapse.

Depression is a serious condition that can cause significant social and emotional problems and reduce the overall quality of life. Relapses in depressive episodes are common and may result in a patient's reluctance to follow a treatment regimen, thus making the episode more severe. Safe and effective therapies to prevent depression relapse are needed. This study will compare three different approaches to determine which is most effective in preventing relapses in depressive episodes.

This study will comprise 2 parts. In Part 1, all participants will receive antidepressant medication for 6 months. Participants whose depression symptoms do not improve will complete their study participation at the end of Part 1. Participants who respond to their regimen will be enrolled in Part 2. This part will last 18 months. During Part 2, participants will be randomly assigned to one of three groups. Participants in Group 1 will continue the drug regimen they began in Part 1. Participants in Group 2 will discontinue their antidepressants and attend an 8-week relapse prevention program. This MBCT program is designed to help participants learn skills that can increase their awareness and change their reaction to stressful events. Participants in Group 3 will have their antidepressant medication from Phase 1 switched to a placebo without their knowledge. Self-report scales will be used to assess the depressive symptoms of participants at the beginning of the study, at the end of Phase 1, and at the end of the study, after Phase 2.

Eligibility Criteria:
Inclusion Criteria:

* Meet DSM criteria for recurrent major depressive disorder, defined as at least one major depressive episode within 3 years prior to study entry AND at least 2 months of normal functioning following the episode

Exclusion Criteria:

* Depression secondary to a concurrent medical disorder
* Current use of medication that could cause depressive symptoms
* A rating of level 2 or higher on the Index of Treatment Refractory Depression
* Current diagnosis of any of the following psychiatric disorders: psychotic or organic mental, bipolar, primary obsessive compulsive, borderline personality, antisocial personality, or eating
* Current diagnosis of comorbid chronic depression that is disabling
* Current substance abuse
* Score less than 14 on the Hamilton Rating Scale for Depression-17 (HRSD-17)
* At risk for suicide
* Pregnancy or plan to become pregnant during the study
* Practice meditation more than once a week or yoga more than twice a week at study entry
Benefit of Elevation of HDL-C in Women

The combination of HDL-C elevation, lowering of triglycerides and further LDL-C reduction accomplished by the addition of niacin to statin medication would improve endothelial function as compared to LDL-C reduction alone in patients with and without coronary artery disease and the combination of low HDL-C/high triglycerides.

The combination of lipid lowering therapy would have beneficial effects on markers of inflammation. These benefits would be particularly evident in women.


Eligibility Criteria:
Inclusion Criteria:

* Stable CAD(coronary artery disease) patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl
* Well-controlled diabetes with HbA1C \< 7.5 currently on statin therapy, able to tolerate Niacin without unstable blood glucose levels with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl
* Stable patients on statin therapy with LDL-C between 90-135mg/dl and triglycerides \> 150mg/dl

Exclusion Criteria:

* History of MI(myocardial infarction), PTCA(percutaneous transluminal coronary angiography) or surgery within previous 3 months
* Currently on Niaspan and unwilling to withdraw Niaspan therapy or known intolerance to niacin
* Active or known gall bladder disease
* Pregnant or nursing women
* Significant comorbidity that precludes participation
* Significant liver disease, active alcoholism, or LFT(liver function test) \>1.5x's ULN( upper limit of normal) at screening
* Diabetes with Hg A1C(hemoglobin A1c) \< 7.5
* PI perceived inability to comply with protocol