cyrilzakka/clinical-trials huggingface dataset:
Phase II Clinical Study of Pegylated Liposomal Doxorubicin Hydrochloride Injection as 2nd-line or Later Therapy in Patients With Mullerian Carcinoma (Epithelial Ovarian Carcinoma, Primary Carcinoma of Fallopian Tube, Peritoneal Carcinoma) Having Prior Platinum-Based Chemotherapy

The purpose of this study is to assess the effectiveness and safety of pegylated liposomal doxorubicin hydrochloride injection in Japanese patients with Mullerian carcinoma. This clinical study is a multi-center, non-randomized, open-label study in Japanese patients with Mullerian carcinoma (including epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma) with a prior history of platinum-based chemotherapy. Eighty patients will be administered intravenously at least two cycles of 50 mg/m2 of pegylated liposomal doxorubicin hydrochloride every 4 weeks to investigate the effectiveness and safety of the treatment.

Pegylated liposomal Doxorubicin hydrochloride is intended to change the pharmacokinetics of conventional doxorubicin in the blood and to improve the safety and effectiveness of the drug. Pegylated liposomal doxorubicin hydrochloride has been approved in many countries including US and EU, becoming a standard drug for 2nd-line therapy in ovarian cancer and AIDS-related Kaposi's Sarcoma. This clinical study was planned to assess effectiveness and safety for Japanese patients with Müllerian carcinoma (including epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma), who had a prior history of receiving platinum-based chemotherapy such as Cisplatin (which is considered to be the standard chemotherapy for ovarian carcinoma). In this study, at least two cycles of pegylated liposomal doxorubicin hydrochloride 50 mg/m2 will be intravenously administered to 80 patients every 4 weeks. These patients include twenty 2nd-line "platinum-sensitive" and sixty "platinum-resistant" 2nd-line or 3rd-line patients. Pegylated liposomal doxorubicin hydrochloride 50 mg/m2 will be given by intravenous drip infusion on day 1. After this, a 27-day drug-free period will be followed as one cycle. At least two cycles will be given as long as the patient does not meet the discontinuation criteria.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ovarian cancer who had a response to initial treatment but then relapsed within 12 months are eligible
* Patients with ovarian cancer who have received one or two prior chemotherapy treatment are eligible
* Patients must have measurable disease, good performance status and adequate major organ function

Exclusion Criteria:

* Patients with concomitant disease that may affect the conduct of the study and the evaluation of pegylated liposomal doxorubicin hydrochloride
* Patients with systemic infection
* Patients with active second cancer besides the ovarian cancer
* Patients with pleural effusion or ascites requiring continuous drainage at the time of enrollment
* Patients with pericardial fluid requiring drainage
* Patients with myocardial infarction and/or angina attack within 90 days prior to enrollment.
Efficacy Assessment of Two Antibiotic Prophylaxis Regimens in Oral and Maxillofacial Trauma Surgery

The study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients with facial fractures admitted to the Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital attached to the Federal University of Rio Grande do Norte.

The study set out to evaluate the efficacy of two antibiotic prophylaxis regimens in patients with facial fractures admitted to the Oral and Maxillofacial Surgery and Traumatology services of the Onofre Lopes University Hospital attached to the Federal University of Rio Grande do Norte.This clinical study was prospective, randomized and controlled. Patients underwent surgery for facial fracture reduction and fixation under general anesthetic. Prior to surgery, patients were randomly divided into two groups. Group 1 patients each received 2g of Cefazolin (Cefazolin Sodium - Ampoule- 1g - Genéricos Brasil), administered intravenously but none was administered in the post-operative period. Group II patients received the same dose prior to the operation but in the post-operative period they also received 4 additional 1 g doses of Cefazolin intravenously, completing a 24 period of antibiotic prophylaxis. In the case of operations that lasted for more than 4 hours, an additional 1g dose was given.

The surgical operations involved intra and extra-oral interventions and when required internal rigid fixation was undertaken using titanium plates and screws. Patients were given advice on oral hygiene procedures to be followed in the post-operative period that included chlorhexidine (0.12%) oral rinses and care to be taken with the surgical wounds.

Post-operative follow up was conducted in the 1st, 2nd, 4th and 6th weeks. The criteria used to determine the presence of infection were: a) pus drainage at the fracture site or in the vicinity of the surgical intervention site; b) increased swelling 7 days after the operation; c) presence of a fistula in the area of the surgical intervention or at the site of the fracture, with active drainage; d) other clinical features observed by the evaluator including typical signs of infection such as fever, edema, and localized redness.

Descriptive analysis was made of the independent variables, namely, age, sex, presence of systemic diseases, trauma cause, drug use (tobacco, alcohol, marijuana, crack, cocaine , etc.), the time lapse between the trauma event and the surgical operation, length of the operation, and the measures adopted when infections were detected.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* ASA I, II, III
* have facial fractures, that request surgical treatement, and whitout infection

Exclusion Criteria:

* Patients with pan-facial fractures
* Or requiring surgery longer than six hours
Use of Airtime Amounts to Improve Interactive Voice Response Surveys in Colombia and Tanzania

This study evaluates the effect of three different airtime incentive amounts on interactive voice response (IVR) survey cooperation, response, refusal and contact rates, as compared to control group, in Colombia and Tanzania.

Using random digit dialing (RDD) sampling technique, participants were randomized one of four airtime incentive amounts contingent on them completing the noncommunicable disease risk factor survey. This mobile phone survey will be sent as an interactive voice response (IVR). In IVR surveys, participants use their touch tone key pad to answer pre-recorded questions. (i.e. If you are male, pres 1; If you are female, press 2). This study will be conducted in both Colombia and Tanzania.

Eligibility Criteria:
Inclusion Criteria:

* Access to a mobile phone
* Greater or equal to 18 years of age
* In Colombia, conversant in the Spanish language. In Tanzania, conversant in the Swahili language.

Exclusion Criteria:

* Less than 18 years of age
Effects of "Vitamin N" Nature Immersion Therapy on Stress Levels in Health Care Workers in the City of Bogotá

Recent studies on health personnel in Colombia have evidenced the considerable increase in the levels of stress and anxiety, among other psychological disorders, as a product of the COVID-19 pandemic that is being experienced since 2019 and that implies a greater demand for attention from the affected citizens, with the consequent work overload and tension due to the risk of contagion.

Thus, the present work will allow the generation of new knowledge in relation to the benefits of Vitamin N therapy in Colombia; which can contribute quickly and effectively to the reduction of stress levels, anxiety, insomnia, and depression in individuals, when compared with conventional interventions and result in possible benefits such as the reduction of health problems such as obesity, diabetes, high blood pressure, and diseases associated with the immune system.


Eligibility Criteria:
Inclusion Criteria:

* Persons over 18 years of age
* Health care workers
* Prioritized by the psychosocial risk program
* Complete vaccination schedule for COVID-19

Exclusion Criteria:

* Undergraduate students in the area of health sciences
* Pregnant women
* Allergies or sensitivity to the intervention
* Workers who consume immunosuppressants or corticosteroids
* Workers diagnosed with any type of disease or who have undergone chemotherapy or radiotherapy treatment during the last year
* Persons who have had exposure to X-rays in the last 6 months
Activated Charcoal Use in Chronic Kidney Disease Patients

Hyperphosphatemia management is initially based on restricting dietary phosphorus intake. Hyperphosphatemia is almost always seen in patients on dialysis and may contribute to progressive vascular calcification. Considering that activated charcoal is generally well-tolerated and may have a favorable side effect profile compared to conventional phosphate binders, it presents a promising alternative. Until now, no clinical trial has primarily investigated the effect of activated charcoal on hyperphosphatemia in dialysis patients.


Eligibility Criteria:
Inclusion Criteria:

1. Adult aged ≥18 years with ESRD.
2. Patients who had been on stable maintenance hemodialysis (3 times weekly) for at least 6 months.
3. Patients receiving phosphate binders according to standard protocols established by kidney disease: Improving Global Outcomes (KDIGO).

Exclusion Criteria:

1. Severely malnourished (as diagnosed by the department's dietitian).
2. Treated with overnight dialysis.
3. Primary hyperparathyroidism or persistent serum levels of intact parathyroid hormone greater than 800 pg/mL.
Efficacy of Low-residue Full Nutritive Formula Powder in Bowel Preparation for Colonoscopy

Previously, our team compared the effects of a low-residue full nutrition formula podwer (FNFP) combined with 3 liters of polyethylene glycol(PEG) solution and the self-prepared low-residue diet combined with 3 liters of PEG solution on the quality of bowel preparation for colonoscopy, and the results showed that the adequate bowel preparation rate was significantly improved in low-residue full nutrition formula podwer group. However, there are still a considerable number of patients in the process of taking 3L PEG appeared bloating, abdominal pain, nausea, vomiting and other adverse reactions, indicating some subjects can not tolerate the dosage of 3L PEG. In order to reduce adverse reactions and provide more options for people with low PEG tolerance, this study intends to compare the effects of low-residue FNFP combined with 2L PEG and self-provided low-residue diet combined with 3L PEG on the quality bowel preparation, colonoscopy lesions detection, adverse reactions, and tolerance, compliance and satisfaction of subjects.


Eligibility Criteria:
Inclusion Criteria:

* adult subjects between the ages of 18 and 75 who were scheduled for screening, monitoring, and diagnostic colonoscopy.

Exclusion Criteria:

* severe heart, brain, lung, kidney complications or a history of acute myocardial infarction within six months.
* a history of abdominal or pelvic surgery, BMI \> 28 or BMI \< 18.5, inflammatory bowel disease, constipation (less than 3 bowel movements in the past week, with strenuous bowel movements, hard stool, small volume), or intestinal obstruction.
* imaging and laboratory tests are highly suspicious of colorectal cancer or warning signs and symptoms of colorectal cancer: blood in the stool, black stool, unexplained anemia and significant weight loss, abdominal mass, and positive digital rectal examination.
Acupuncture Combined With Pulmonary Rehabilitation: Are There Additional Benefits?

The hypothesis of this study was that acupuncture in conjunction with standard care of pulmonary rehabilitation improves outcome measures compared to pulmonary rehabilitation alone.

Pulmonary Rehabilitation is recognized as a pivotal component in International Guidelines for the management of chronic obstructive pulmonary disease (COPD). In patients with COPD, clinical research using acupuncture has reported a significant reduction in the use of medications, decrease breathlessness and increased functional capacity. To our knowledge, this is the first time that these two treatments were combined to compare functional, physiological, biological and emotional/QOL outcomes in this cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of COPD based on the GOLD staging of the disease
* Medical Research Council Score of 3 or Above
* Ability of mobilize independently
* Motivated to exercise independently

Exclusion Criteria:

* No evidence of COPD on spirometry
* Acute exacerbation within 4-6 weeks
* Evidence of Ischemic Heat Disease/acute changes on ECG
* Uncontrolled hypertension
* Insulin dependent diabetic
* Inability to exercise independently or musculoskeletal/neurological conditions which would prevent completion of the course
* Fear of needles
* Lung Cancer
* Previous attendance at pulmonary rehabilitation
Non-invasive Brain Stimulation in Subjects with Major Depressive Disorder

Introduction The study involves the recruitment of outpatients suffering from Major Depressive Disorder (MDD), diagnosed according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Patients are on selective serotonin reuptake inhibitors (SSRIs) for at least 4 weeks and present residual depressive symptoms, defined by a score greater than 7 on the Hamilton Depression Rating Scale (HDRS-17).

Study Objectives

Primary Objective To investigate the effects of transcranial direct current stimulation (tDCS) on depressive symptoms in patients with depression, randomized into a "test" group and a "sham" group.

Secondary Objectives

To investigate the effects of tDCS on cognitive function in patients with depression, randomized into a "test" group and a "sham" group.

To evaluate changes in blood biomarkers, neurophysiological, and neurosonological variables after tDCS treatment in the same group of patients.


Eligibility Criteria:
Inclusion criteria:

* Patients with Major Depressive Disorder (MDD), as defined by the DSM-5-TR criteria;
* Presence of residual symptoms, defined by a Hamilton Depression Rating Scale score over 7;
* Age over 18 years.

Exclusion criteria:

* MMSE under 18 and/or CDR over 2;
* Other neurological diseases (stroke, multiple sclerosis, major head trauma, epilepsy) or psychiatric disorders other than those included (schizophrenia, bipolar disorder, etc.);
* Patients with severe clinical conditions, acute or uncontrolled chronic medical diseases;
* Endocrine diseases, vitamin deficiencies, or exposure to drugs associated with cognitive impairment and/or mood deflection;
* Alcohol abuse or recreational drug use;
* Contraindications to MRI and TMS (carriers of implanted devices, patients who have undergone craniotomy, presence of metal fragments or prostheses, history of epilepsy);
* Pregnant or breastfeeding women.
Evaluation of Probiotics in the Treatment of Portal Hypertension

This study is to evaluate the role of probiotics in the treatment of portal hypertension. In particular the role of probiotics on gut microbiota in liver cirrhosis patients will be studied and compared with cytokines and other substances implicated in the pathogenesis of portal hypertension. The hypothesis whether probiotics may change the prognosis of patients with portal hypertension will be studied. The hypothesis whether probiotics may halt the pathologic cascade of events leading to various complications (e.g. hepato-renal syndrome, spontaneous bacterial peritonitis, bleeding varices) will be reviewed.

Studied probiotics: VSL3

Eligibility Criteria:
Inclusion Criteria:

* Confirmed liver cirrhosis (liver biopsy or typical imaging studies)
* Confirmed portal hypertension
* 18 years and older
* compliant patients

Exclusion Criteria:

* Antibiotic treatment in last 3 months
* Lactulose treatment in last 3 months
* Patients taking NSAIDS in lat 3 months
* Steroid treatment in last 3 months
* Ongoing and active infection
* Pregnant woman
* Cancer diagnosis
* decompensated diabetes mellitus
* active or past treatment with recombinant cytokines (e.g. anty TNF, interferon etc)
* medication altering function of CNS, suffering from neurological or ophthalmological conditions
* initiating the therapy with beta blockers within the prior 12 weeks
* mental disease
Phase I Study of Palomid 529 a Dual TORC1/2 Inhibitor of the PI3K/Akt/mTOR Pathway for Advanced Neovascular Age-Related Macular Degeneration

Palomid 529 is a dual TORC1/2 inhibitor of the PI3K/Akt/mTOR pathway having broad activity in angiogenesis and cellular proliferation. Palomid 529 will be examined to determine if the safety, tolerability and pharmacokinetic profile of single ascending doses when administered intravitreally or subconjunctivally.


Eligibility Criteria:
Inclusion Criteria:

* Best corrected visual acuity in the study eye between 20/100 and 20/800 (between 53 and 4 ETDRS letters read), and better or equal to 20/200 (minimum of 34 letters read) in the fellow eye.
* Subfoveal choroidal neovascularization (CNV) due to AMD
* Total area of the lesion (including blood, neovascularization and scar/atrophy) must be \< 12 DA.
* Only 1 eye will be treated in the study. If both eyes are eligible, the investigator will select the eye with the most active CNV
* Clear ocular media and adequate pupillary dilatation to permit good stereo fundus photography for screening
* Intraocular pressure of 21 mm Hg or less
* Retinal thickness ≥ 250 μm by OCT, with presence of intraretinal or subretinal fluid

Exclusion Criteria:

* Any retinovascular disease or retinal degeneration other than AMD
* Serous pigment epithelial detachment without the presence of neovascularization
* Previous posterior vitrectomy or retinal surgery
* Any periocular infection in the past 4 weeks
* Concomitant therapy with anti-VEGF therapies, e.g. Avastin, Lucentis or Macugen, or previous use of these agents within 60 days of screening
* Concomitant therapy with intravenous or intravitreous corticosteroids or use within 90 days of screening
* Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography
* Cataract surgery in the study eye within 3 months of screening
* Intraocular surgery in the study eye within 3 months of screening
* Presence of ocular infection in the study eye
* Presence of severe myopia (-8 diopters or greater) in the study eye
Gene Expression Monitoring of Mononuclear Cells (MNC) Subpopulations and Immunological Status and Metabolome Defining of Healthy Population

Study on healthy volunteers is focusing on analysis of transcriptome profile fluctuations in healthy population in three mononuclear cell types (CD4+ cells, CD56+ cells and CD4+CD25+ cells)and should provide a reference for comparison with transcriptomic data of any disease state.Furthermore, metabolome and immunological status are defined on same samples.


Eligibility Criteria:
Inclusion Criteria:

* age: 20-70 years
* healthy

Exclusion Criteria:

* acute or chronic diseases
* pregnancy
Results From a Health System-wide Implementation of a Quality of Life Questionnaire

The purpose of this retrospective chart review pilot study is to research the results and scores of the QOL questionnaire implemented across Allina Health clinics. This study will investigate average QOL scores by clinical population and demographic group, the change in scores over time, and the effect of clinical interventions on QOL scores. The results will provide insight into QOL trends within different patient populations and provide guidance regarding optimal treatment plans so that Allina caregivers can positively impact patients' QOL.

Quality measures, including quality of life (QOL), have become an increasingly important area of interest for health systems across the country. Systematic approaches to collect patient QOL data are needed to properly understand and act on this information. At Allina Health, the process of systematically collecting this information began in July, 2012. The information is not only collected by providers, but used to enhance the patient experience and provide patients with an active voice in their care. By considering QOL as another vital sign, Allina caregivers have an instantaneous understanding of the patient's health status and can utilize the data in real time. Additionally, by collecting this information at each visit, providers also have a longitudinal perspective of the patient's QOL and the health of the population of individuals under their care. Consequently, they can provide patients with resources and support that can have a positive impact on their health and well-being.

The purpose of this retrospective chart review pilot study is to research the results and scores of the QOL questionnaire implemented across Allina Health clinics. This study will investigate average QOL scores by clinical population and demographic group, the change in scores over time, and the effect of clinical interventions on QOL scores. The results will provide insight into QOL trends within different patient populations and provide guidance regarding optimal treatment plans so that Allina caregivers can positively impact patients' QOL.

Eligibility Criteria:
Inclusion Criteria:

* patients seen at an Allina Health outpatient facility who complete a PROMIS-10 questionnaire between July 1, 2012 and December 31, 2016.

Exclusion Criteria:

* patients who did not allow their records to be used for research purposes are not included in the study
Comprehensive Police Fatigue Management Program

Police officers work some of the most demanding schedules known, which increases their risk of sleep deprivation and sleep disorders. The need to work frequent overnight shifts and long work weeks leads to acute and chronic partial sleep deprivation as well as misalignment of circadian phase. The public expects officers to perform flawlessly, but sleep deprivation and unrecognized sleep disorders significantly degrade cognition, alertness, reaction time and performance. In addition, both acute and chronic sleep deprivation adversely affect personal health, increasing the risk of gastrointestinal and heart disease, impairing glucose metabolism, and substantially increasing the risk of injury due to motor vehicle crashes.

We propose to conduct a randomized, prospective study of the effect on the safety, health, and performance of a police department of a Comprehensive Police Fatigue Management Program (CPFMP) consisting of the following interventions:

1. identification and treatment of police with sleep disorders;
2. caffeine re-education; and
3. initiation of a sleep, health and safety educational program.

These interventions were chosen because we believe them most likely to lead to measurable improvements on work hours, health, safety, and job performance, and because they are cost effective. The success of the CPFMP will be assessed through an experimental comparison with a standard treatment group that will receive sleep education in the absence of any accompanying interventions. The overall goal of our team will be sleep health detection and treatment program that can be disseminated to practitioners, policymakers and researchers nationwide to reduce police officer fatigue and stress; enhance the ability of officers to cope with shift schedules; improve the health, safety and performance of law enforcement officers; and thereby improve public safety.


Eligibility Criteria:
Inclusion Criteria:

* Active Sworn Police Officers

Exclusion Criteria:

* None