cyrilzakka/clinical-trials huggingface dataset:
A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children

The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in healthy adults, adolescents, and children.

This study is a randomized, blind, single-center, controlled phase I clinical trial. The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The positive control is a commercialized live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP), and the negative control is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are healthy, and will be randomly assigned into experimental group, positive control group, or negative control group in the ratio 1:1:1.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer between 1 - 49 years old;
* Proven legal identity;
* Guardian(s) of the volunteer and/or volunteers themselves should be capable of understanding the written consent form, and such form should be signed before the infant being included into this study;

Exclusion Criteria:

* Prior vaccination with varicella vaccine or with history of varicella zoster virus (VZV) infection;
* Axillaty temperature \> 37.0 °C;
* Breast feeding, pregnant, or expected to conceive during the period of this trial;
* History of allergy to any vaccine or vaccine ingredient, or serious adverse reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic edema, abdominal pain, etc;
* History of epilepsy, seizures or convulsions, or a family history of mental illness;
* Autoimmune disease or immunodeficiency;
* Severe malnutrition, congenital malformation, developmental disorders, or serious chronic diseases;
* Acute disease or acute stage of chronic disease within 7 days prior to study entry;
* Receipt of any of the following products:

  1. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;
  2. Any live attenuated vaccine within 1 month prior to study entry;
  3. Any blood product, immunosuppressant, hormone, or other investigational medicine(s) within 30 days prior to study entry;
* Any significant abnormity of heart, lung, skin, or pharynx;
* Any of the pre-immune test results of the following indexes of laboratory tests showed clinically significant abnormity:

  1. Blood routine examinations: hemoglobin (Hb), white blood cells (WBC) count;
  2. Blood biochemistry detections: alanine transferase (ALT), total bilirubin, blood urea nitrogen (BUN), creatinine;
  3. Urine routine tests: urine protein, urine glucose, urine erythrocyte
* Any other factor that suggesting the volunteer is unsuitable for this study based on the opinions of investigators;
Evidence Based Dissemination for Mammography Adherence in Safety Net Communities

Breast cancer is the most common cancer and the second leading cause of cancer related death in American women. Regular screening, early diagnosis, and timely treatment initiation have been shown to reduce breast cancer morbidity and mortality. However, disparities continue to exist across the breast cancer continuum for underserved women, particularly minority women. The reduction of disparities in breast cancer outcomes is a major goal of Healthy People 2020 and the National Cancer Institute. However, the preventable burden of late stage breast cancer will continue until the investigators close the gap between what is known about prevention and what is implemented in the community. Although many sources of information exist about theory and \[theory-\] and evidence-based interventions (EBIs) to promote mammography screening, their adoption and use in the community has been limited and haphazard at best.

In order to effectively reach underserved women and reduce breast cancer disparities, D\&I efforts should target the healthcare delivery system where these women receive service - the so called "safety net". Within the safety net, federally qualified health centers (FQHCs), provide comprehensive primary health care services for underserved communities regardless of ability to pay, including mammography screening. Our team has successfully pilot tested a National Cancer Institute research tested intervention program (RTIP) with underserved women and were able to reduce no-show rates from 44% to 19%. In order to accelerate the adoption and implementation of our EBI within the safety net, the investigators will use a two-step approach based on the consolidated framework for implementation research (CFIR), and intervention mapping. The investigators will actively disseminate the EBI through a unique breast health collaborative with a wide membership of FQHCs, support implementation through training and evaluate the adoption, implementation, sustainment and effectiveness of the EBI. The investigators will use a clinic clustered stepped wedge design for implementation in FQHCs.

Eligibility Criteria:
Inclusion Criteria:

* Underserved as defined by income \<=200% of the federal poverty level for a family of four
* Uninsured
* In need of mammography screening; has received clinical breast exam and referral to screening
* Has upcoming screening appointment

Exclusion Criteria:

-
Evaluation of a Contraceptive Counseling Intervention in Deprived Neighborhoods: SIRIAN Randomized Controlled Trial

This study evaluates the effects of a community-based counseling intervention to improve contraception among residents in two deprived neighborhoods in Barcelona (Spain). Half of the participants received contraceptive counseling at the community setting, while the other half acted as a control group.

To evaluate the effects of a community-based counseling intervention to improve contraception among residents in deprived neighborhoods a randomized controlled trial is performed. Women aged 14-49 years and men aged 14-39 years from two low income neighborhoods in Barcelona (Catalonia, Spain) who had not undergone an irreversible contraceptive method and aren't planning a pregnancy have been recruited in 2011-13. The intervention consists of a culturally developed and theoretically-based brief counseling in community settings. The primary outcome is the consistent use of very effective contraceptive methods (optimal use). Secondary outcomes analyzed are the incorrect use of very effective contraceptive methods and use of less effective methods stratified by sex and migrant status. Differences within subgroups from baseline to 3 months - follow up are analyzed and intervention effects are assessed with adjusted robust Poisson regressions.

Eligibility Criteria:
Inclusion Criteria:

* Women living in the selected neighbourhoods aged 14-49 years
* Men living in the selected neighbourhoods aged 14-39 years

Exclusion Criteria:

* Having undergone an irreversible contraceptive method
* Whishing or planning a pregnancy in the next year
TD-6450 SAD and MAD in Healthy Subjects

This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening. Females are considered to be of non childbearing potential if they have had a hysterectomy or tubal ligation (documentation required) or are postmenopausal (amenorrheic for at least 2 years) with a follicle stimulating hormone (FSH) level \>40 IU/L
* Subject has a body mass index 18 to 30 kg/m2, inclusive, and weighs at least 50 kg.

Exclusion Criteria:

* Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Subject has an estimated creatinine clearance of \<90 mL/min at Screening or Day -1, calculated using the Cockcroft-Gault equation.
* Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).
Endostar Combined With mFOLFOX6 for First-line Treatment of Metastatic Colorectal Cancer

This study is to assess the efficacy and safety of Endostar combined with mFOLFOX6 in untreated metastatic colorectal cancer patients, and to find the markers that may predict the efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic colorectal cancer (adenocarcinoma)
* At least one measurable lesion (RECIST criteria)
* Life expectancy ≥ 3 months
* ECOG performance status 0-2
* Adequate hematologic function: ANC ≥ 1.5×109 /L，Hb ≥ 90 g/L，PLT ≥ 100×109 /L
* Adequate renal function: Cr ≤ 1.25×ULN or Creatinine clearance ≥ 60 ml/min
* Adequate hepatic function: BIL ≤ 1.5×ULN, ALT/AST ≤ 2.5×ULN, Alkaline phosphatase ≤ 5×ULN
* Patients have not previously received palliative chemotherapy, immunological/ biological treatment
* No adjuvant chemotherapy in last six months
* Target lesion has not received local radiotherapy
* Written informed consent

Exclusion Criteria:

* Diagnosis of colorectal neuroendocrine tumor, undifferentiated carcinoma, adenosquamous carcinoma, squamous cell carcinoma
* Evidence of serious or uncontrolled infection
* Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension)
* Pregnant or lactating women
* Women of childbearing potential refused to practice acceptable methods of birth control to prevent pregnancy
* Allergic to any of the study drug
* Intestinal obstruction, intestinal perforation, or stroke within 3 months
* Participation in other clinical studies
PINS Stimulator System for Deep Brain Stimulation to Treat Obesity

The purpose of this clinical study is to verify the long term effecacy and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with obesity.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is aged 18 to 65.
2. Body Mass Index \[BMI\] \>40 kg/m2.

Exclusion Criteria:

1. Medical contraindications for general anesthesia, craniotomy, or DBS surgery
2. Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
3. Participate in other clinical trial;
4. Has a life expectancy of \< 1 year.
5. The investigator and/or enrollment review committee, would preclude participation in the study.
Coronary Revascularization in Patients With Dialysis in China

China patients in end stage renal disease receiving maintenance dialysis have a high risk of cardiovascular disease (CVD), with a prevalence of 45.5% approximately, and coronary artery disease (CAD) has been identified as the most common one. It remains unclear that what their treatment status is and whether this group of patients can benefit from revascularization in China. The investigators plan to recruit around 30 hospitals from 7 regions as study centers, which represent different levels of economic development in Mainland China. The detailed information includes demographics, medical history, coronary angiogram, in-hospital treatment and procedures, short-term and long-term outcomes. The aim of the study is to provide the real world knowledge about current status of coronary revascularization and prognosis in patients with CAD and dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above and 85 or below.
* Receives peritoneal dialysis or hemodialysis more than 1-time weekly and for more than 3 months.
* Diagnosed with coronary artery disease, including STEMI, NST-ACD, stable coronary artery disease.

Exclusion Criteria:

* Pregnancy or lactation.
* Can't be cooperative because of a mental illness or other reasons.
* Malignant tumor or severe hepatic disease.
* Life expectancy is less than 1 year.
Evaluation of Chronotype and Central Sensitization in Patients With Fibromyalgia Syndrome

The aim of study is to examine the chronotype preferences of patients with fibromyalgia syndrome and the relationship between central sensitization and chronotype, and to examine its relationship with pain intensity, disability and quality of life.

Fibromyalgia Syndrome (FMS); It is a syndrome characterized by chronic pain occurring in more than one part of the body and accompanied by fatigue, sleep disturbance, impairment in quality of life and daily functionality. Although FMS is seen in different age groups, it is most common in middle-aged women. FMS is classified as central sensitization syndrome, in which there is an abnormal response to painful stimuli and the processing of nociceptive stimuli in the central nervous system. In patients with FMS, pain may cause sleep disturbances such as non-restorative sleep or difficulty initiating or maintaining sleep. It is estimated that 65-99% of patients with FMS experience sleep disorders. Circadian rhythms reflect 24-hour physiological and behavioral cycles within each individual. Based on individual differences in the timing of these innate rhythms, individuals can be divided into 3 phenotypes (i.e., chronotypes): morning type (M-highest level of alertness in the morning), evening type (E most active in the evening), and intermediate type (I-neither M nor E). Chronotype is explained by both genetic and environmental factors and can be considered a fairly robust trait throughout adulthood. A study assessing 1548 people with FMS with an online survey including questions about sleep quality, well-being, pain, chronotype and FMS impact shows that late chronotypes are more affected by fibromyalgia. In another study conducted in 2019, patients with FMS were grouped according to chronotype preferences and showed that there was a strong relationship between FMS severity and poor quality of life in evening individuals.

The aim of study is to examine the chronotype preferences of patients with fibromyalgia syndrome and the relationship between central sensitization and chronotype, and to examine its relationship with pain intensity, disability and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed according to ACR 2016 Fibromyalgia Syndrome Diagnostic criteria Continuing complaints for at least 3 months

Exclusion Criteria:

* Neurological and Inflammatory diseases Pregnancy Malignancy
The "SPARCOL" Study

Mortality following elective colorectal cancer surgery range between 2.5-6% and increase for the elderly and frail patient regardless of T-stage. Around 80% of the patients who present with a colon cancer and is in a condition where surgery is possible will be offered resection of the tumor. A part of the colon is always removed together with the lymph nodes in order to ensure that cancer cells are not left behind. The risk of lymph node metastasis is dependent on several histopathological characteristics of the tumor. The overall risk of lymph node metastases is less than 20 % in patients with early colon cancer. This indicates that the majority of patients with early colon cancer have no benefit of additional resection besides local tumor excision. The alternative to resecting a larger part of the bowel is to make more focused surgery only resecting a small part of the bowel part through a combination of laparoscopic and endoscopic techniques. This new organ sparing approach is called Combined Endoscopic Laparoscopic Surgery (CELS). The investigators aimed to examinate the hypothesis that organ preserving approach (CELS) provides superior quality of recovery in elderly frail patients with small colon cancers when compared with standard surgery in RCT.


Eligibility Criteria:
Inclusion Criteria:

* Male and Female participants providing written informed consent aged 75 years and older
* PS score ≥1 and /or ASA score ≥3
* Macroscopically or pathological colonic adenocarcinoma
* Clinical TNM classification T1/T2 N0 M0
* Eligible and suitable for CELS resection according to MDT
* Tumor must be located in colon, and not involving the ileac valve or taking up more than 50% of the lumen in an air-distended bowel wall

Exclusion Criteria:

* Unable to give informed consent
* Histological high-risk features in biopsy material from tumor (mucin, signet cells, de- differentiation)
* Suspected other malignancy than adenocarcinoma (e.g. neuroendocrine tumors)
* Preoperative chemo/radiotherapy
* Creation of stoma perioperative
* Non-Danish speakers
The Effects of Bolus, Intermittent and Continuous Enteral Feeding on Blood Glucose and Feeding Intolerance in ICU Patients With Sepsis

Comparison of the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level and enteral feeding intolerance in adult intensive care unit patients with sepsis.

in this prospective, controlled trial the main aim is to evaluate the effects of bolus, intermittent and continuous enteral feeding techniques on plasma glucose level in intensive care patients with sepsis diagnosis and to determine whether they are superior to each other in providing norma-glycemia. The secondary aim is to determine the effect of these 3 different enteral feeding techniques on enteral feeding intolerance.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized in ICU for more than 3 days
* Ages between 18-70 years
* APACHI II is in the range of 8-25
* BMI in the range of 18.5-30
* Able to receive enteral nutrition from N/G
* Intubated on ventilator support
* No previous diagnosis of Diabetes Mellitus,
* Those who have not had Gastro intestinal System surgery in the last 6 months
* Patients not receiving inotropic support
* not receiving hemodiafiltration
* No history of allergy to the food used
* Patients with a focus of infection and/or culture-positive patients diagnosed with sepsis according to Q SOFA (cultures were taken from all patients)

Exclusion Criteria:

* patient's death during the study
* Taking more than 40 mg of IV steroids daily
* Increased baseline APACHI II score
* Development of the patient's need for inotropes
* Elimination of inclusion criteria
* negative culture
The Queens Library HealthLink Project

To determine whether community based participatory action research leads to more effective cancer prevention and control in underserved communities compared to traditional, "topdown" programs.

To examine how communities engage in the participatory research process, in order to develop locally tailored initiatives for cancer education, prevention and control.

To examine whether and how long program effects are sustained after completion of the intensive collaborative program planning intervention.

Eligibility Criteria:
Inclusion Criteria:

* This project is intended to reach participants over the age of 18 within each sampled neighborhood, inclusive of both women and men of all ethnic and language groups. As such, our outcomes assessment strategy is similarly inclusive. Specific sources of data and sampling strategies for different measures are detailed in Section 7, as part of our assessment plan.

Exclusion Criteria:

* Individuals younger than 18 years of age will not be included in this study.
Combined Drug Therapy in Lateral Fragility Fractures of the Femur

It was conducted a prospective study with a series of 50 patients treated by intramedullary nail using Clodronic acid and Vitamin D (study group including 25 patients) and patients with the same fractures treated with Vitamin D alone (control group including 25 patients).

One independent observer performed clinical, biochemical and functional evaluations at T0 (1st day post-surgery) and at T1 (12 months later) Biochemical markers (serum calcium level, serum phosphate level, PTH (parathormone), Vitamin D, serum C-terminal telopeptide), VAS (Visual Analogic Scale) and HHS (Harris Hip Score) score, and femur densitometric views were administered at each evaluation.


Eligibility Criteria:
Inclusion Criteria:

* femur fractures type 31-A1, A2, (Muller ME, Nazarian S, Kock P et al.);
* age 60 - 85 years;
* co-operative patients;
* Body Mass Index (BMI) \< 30 Kg/m²;
* patients treated by intramedullary nailing surgery (PFNA Synthes®);
* patients with osteoporosis disease if T-Score\< -2,5;

Exclusion Criteria:

* patients with heart, kidney, neurological diseases;
* patients with metabolic and systemic disease (rheumatoid arthritis, diabetes mellitus);
* previous surgery or severe osteoarthritis of lower limbs;
* specific drugs treatments such as anticoagulants or psychiatric drugs.
Cognitive Effects of Citicoline in Men and Women With Age-Associated Memory Impairment

The objective of this trial is to determine the effects of citicoline on cognitive performance in healthy Men and Women with Age-Associated Memory Impairment compared to a placebo.

This study is a 12-week, randomized, double-blind, placebo-controlled trial of citicoline in healthy men and women with Age-Associated Memory Impairment. Cognitive assessments will be performed to determine whether citicoline administration with supportive memory, compared to placebo administration.

Eligibility Criteria:
Inclusion Criteria:

* male or female, 50-85 years of age
* at least a high school diploma or the equivalent
* self-reported memory loss
* scores ≥24 on the Mini-Mental State Examination, ≥85 on the Kaufman Brief Intelligence Test, Second Edition, ≤5 on the Geriatric Depression Scale, and 4, 3, or 2 on the Spatial Span Test
* no health conditions that would prevent him or her from fulfilling the study requirements on the basis of medical history and routine laboratory test results

Exclusion Criteria:

* color blind
* abnormal laboratory test results
* major medical or neurological illness
* female who is pregnant, planning to be pregnant during the study period
* requiring treatment with a drug which might obscure the action of the study treatment