cyrilzakka/clinical-trials huggingface dataset:
Compression Therapy Following Truncal Vein Endothermal Ablation And Distal Sclerotherapy

Study purpose is to research whether compression therapy is beneficial after truncal vein RF-ablation and distal sclerotherapy done in the same session when needed. Patients will be randomised to either no compression group (Group I) or compression group (Group II)

In this study two endpoints are anticipated, first endpoint is to assess safety and adverse effects between groups at 1 month endpoint. Also post-procedural pain and need for painkillers are monitored. Compliance and reasons for non-compliance is recorded in compression group.

Second endpoint is to assess mid-term (6 months) success of truncal vein occlusion as well as changes in Aberdeen score between groups compared to pre-operative stage.

Study design is non-inferiority trial where in 5% margin occlusion of truncal vein is expected to be equal in two groups at 6 six months. Power analysis showed need for 85 patients per group and taking into account possible dropouts anticipated n = 200.

Eligibility Criteria:
Inclusion Criteria:

* Duplex ultrasound verified GSV and/or SSV incompetence (0.5 seconds or more)
* Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
* Truncal vein insufficiency (GSV and/or SSV) treatable with Radiofrequency ablation

Exclusion Criteria:

* History of pulmonary embolism or deep venous thrombosis
* Large (\>12mm) truncal vein diameter
* CEAP C5-C6
* Patient unwilling to participate
Juice Preference in the Emergency Department

ED patients who are able to drink juice will be approached and asked their beverage preference.

Once per week for 26 weeks, patients will be enrolled during a randomly selected 1-hour block. The random blocks will be assigned using STATA. During these enrollment periods, all current ED patients will be screened by the treating physicians and research associates, excluding patients in the "Special Care" unit, where most patients are intoxicated with alcohol.

Eligibility for oral consumption of water and juice will be determined by treating physicians. Patients who are deemed eligible to drink water or juice will be approached and asked their beverage preferences. Their response will be recorded, and the beverage will be procured for them.

Eligibility Criteria:
Inclusion Criteria:

* All Emergency Department patients, of any age, who are cleared by their treating physician to drink juice, and are able to communicate a juice preference. Patients are only enrolled during randomly selected 1-hour blocks once per week for 26 weeks.

Exclusion Criteria:

* Previously enrolled in the study
* Patients who are placed in the "special care" unit of the Emergency Department, which generally cares for intoxicated patients.
Brain Cell Injury in Patients With A First Episode of Psychosis

Patients experiencing a first episode of psychosis may have brain cell damage due to a chemical process called oxidation. This study will compare patients with psychosis to healthy volunteers to determine if there are differences in their blood that reflect oxidative brain cell damage.

Preliminary research indicated that impaired antioxidant defense and increased lipid peroxidation is associated with brain changes during the onset of psychosis. Oxidative cell injury may contribute to poor outcomes in some patients. This study will define the extent and nature of oxidative cell injury that is associated with psychopathology at the onset of psychosis.

Participants in this study will be patients at the D. D. Eisenhower Army Medical Center who are experiencing a psychotic episode for the first time. Patients will be compared with 40 healthy volunteers (control group) matched with patients for age, gender, education, ethnic background, and occupational status. Patients and volunteers will have blood tests to determine the level of oxidative cell injury. Tests will be performed at onset of psychosis, and after 6 and 12 weeks of neuroleptic drug treatment. Medical histories and MRI scans will be used to examine the relationship of the laboratory tests to the clinical presentation.

Eligibility Criteria:
Inclusion Criteria

* Patients must meet clinical diagnostic criteria for psychosis
* Healthy (control) volunteers must not have any family history of mental illness
Efficacy of DLBS-32 in Subjects With Type-II Diabetes Mellitus

The purpose of this study is to investigate clinical efficacy and safety of DLBS 32 in the management of subjects with type-II-diabetes mellitus and to determine the minimal effective dose of DLBS 32 for subjects with type-II-diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Fasting capillary blood glucose of 127-249 mg/dL at screening
* BMI \>= 18.5 kg/m\^2 or waist circumference of \>= 90 cm (male) or \>= 80 cm (female)
* Normal liver function
* Normal renal function
* OHA-naive type-II-diabetic patients

Exclusion Criteria:

* Symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
* Uncontrolled hypertension
* History of or current treatment with insulin
* Current treatment with systemic corticosteroids or herbal (alternative) medicines
* History of renal and/or liver disease
* Pregnant or breast feeding females
Local Application of Vancomycin Powder in Grade I-IIIA Open Fractures

The purpose of this study is to determine if local administration of vancomycin powder at the site of Grade I-IIIA open fractures at the time of surgery will be an efficacious method to lower infection rates in open fracture treatment and to elucidate any detrimental effects of applying vancomycin powder at the site of open fractures.

Hypothesis:

Local administration of 1 gram of vancomycin powder at the site of primarily closeable Gustilo-Anderson Grade I-IIIA open fractures at the time of surgery, in addition to clinically accepted open fracture management (intravenous antibiotics, surgical irrigation and debridement and stabilization), will significantly decrease the postoperative infection rate in comparison to the current treatment algorithm.

Methods:

Study subjects will be randomized to one of two groups prior to surgery (parallel group design): standard treatment (control group) versus vancomycin powder treatment (experimental group). Each group will have an equal number of subjects. Once randomized, the intervention is then un-blinded to facilitate treatment.

Post-operatively, all patients will receive intravenous antibiotics, such that all patients receive a total of 24 hours of intravenous antibiotics. The surgical drain will be removed at the patient's bedside approximately 24 hours after the surgical procedure. Patients will follow up with their surgeon for routine scheduled visits at approximately 2 weeks, 6 weeks, 12 weeks, and further until aseptic union or resolution of infection. There will be no additional appointments solely for the purpose of research follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature patients ≥18 years of age
* Acute Gustilo-Anderson Type I-IIIA open fracture
* Fracture is deemed primarily closable at initial surgery
* Likely to follow-up with surgeon until fracture is healed
* Ability to understand and agree to Informed Consent

Exclusion Criteria:

* Patients \<18 years of age
* Gustilo-Anderson Type IIIB and IIIC open fractures
* Open fractures requiring multiple operations (i.e. for repeat surgical debridement or staged bone grafting of critical segmental defects)
* Delayed presentation of open fracture
* Pre-existing systemic infection requiring antibiotic therapy
* Allergy to Vancomycin
* Open fracture at the site of a previous fracture or surgical site
* Current skin infection, chronic wounds or known systemic infection
* Unlikely to follow-up until fracture is healed
* Unable to understand or agree to Informed Consent
Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease

Sympathetic activation is a hallmark of end-stage renal disease and adversely affects cardiovascular prognosis. Hypertension is present in the vast majority of these patients and plays a key role in the progressive deterioration of renal function and in the exceedingly high rate of cardiovascular events. Selective catheter-based renal denervation has been shown to be safe and effective in attaining improved and sustained blood pressure control in patients with resistant hypertension and normal renal function. The investigators hypothesize that catheter-based renal denervation is a safe and effective intervention to achieve sustained reduction in sympathetic nerve activity, BP and target organ damage in hypertensive End-Stage Renal Disease (ESRD) patients, which will result in improved cardiovascular outcomes.


Eligibility Criteria:
Inclusion Criteria:

* end stage renal disease
* hypertension (BP≥140/90mmHg)

Exclusion Criteria:

* Individual has renal artery anatomy that is ineligible for treatment as assessed by the interventionalist.
* Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.
Clinical Efficacy of Erythropheresis in High Altitude Polycythemia

The clinical study is aimed to explore the efficacy and safety of erythropheresis in high altitude polycythemia.

The clinical study is aimed to explore the efficacy and safety of erythropheresis in high altitude polycythemia. People reside in highland diagnosed as high-altitude polycythemia were included and randomly divided into two groups. In one group, routine therapy including oxygen inspiration would be performed, while in another erythropheresis would be added. Symptom relief, blood oxygenation, and 6-minute walk test would be assessed and compared in the above two groups.

Eligibility Criteria:
Inclusion Criteria:

1. \>=18 years old;2.High altitude polycythemia; 3.Han nationality who have been in highland for over 12 months; 4. No other complications indicated by general examinations such as chest X-ray, electrocardiogram; 5. patients who are informed and informed consent form are acquired.

Exclusion Criteria:

1. Hypoxemia caused by other respiratory or cardiac diseases or polycythemia vera; 2. Acute or subacute mountain sickness ; 3. Acute or chronic infections and medication history ; 4. Psychiatric disorders or severe neurosis; 5. Malignant myeloproliferative disease; 6. Any contraindications to erythropheresis.
Effects of Tart Cherry Juice on the Body

Tart cherries are a rich source of antioxidants. Studies have shown that tart cherries exert anti-oxidative and anti-inflammatory properties. The purpose of this study is to learn about the effects of drinking tart cherry juice on cardiovascular and cognitive health.

Thirty-seven older adults were randomly assigned to drink 16 oz per day of either tart cherry juice or placebo drink for 12 weeks. Blood and urine samples were collected at baseline and 12 weeks to assess biomarkers. Physical activity and 3-day diet records were also collected throughout the study.

Eligibility Criteria:
Inclusion Criteria:

• Age 65-80

Exclusion Criteria:

* Allergic to tart cherries
* Heavy smoker
* Taking medications that affect cognitive function
* History of neurological disorders
* History of traumatic brain injury
* History of stroke
* Clinical diagnosis of diabetes
* Clinical diagnosis of Alzheimer's Disease/Dementia
* GI disease
* Kidney disease
* Liver disease
* Cancer
Implementation Study of Dementia Guidelines in Primary Care

The purpose of this study is to determine whether a specially developed Dementia Training Program for duos of general practitioners and primary care nurses is able to increase the number dementia diagnoses in elderly people living in the community and increase the adherence to clinical dementia guidelines

Background Early diagnosis of dementia benefits both patient and caregiver. Nevertheless, dementia in primary care is currently under-diagnosed in developed countries. In several countries educational interventions were developed to improve dementia diagnosis and management in primary care. Some of these interventions were successful in increasing the number of dementia diagnoses and in changing attitudes and knowledge of health care staff. However, none of these interventions focussed on collaboration between GPs and nurses in dementia care. We developed a Dementia Training Program (DTP) aimed at stimulating collaboration in dementia primary care. We expect it to increase the number of cognitive assessments and dementia diagnoses, as well as to improve attitudes and knowledge of GPs and nurses.

Methods/Design The DTP is a complex educational intervention and consists of 2 workshops, a coaching program, and case-based consultations either face-to-face or by phone or e-mail, access to an internet forum, and a Computerized Clinical Decision Support System on dementia diagnostics and management. 100 duos of GPs and nurses will be recruited, from which 2/3 will be allocated to the intervention group and 1/3 to the control group. The effects of implementation of the DTP will be studied in an assessor blinded cluster-randomised controlled trial. Primary outcomes are the number of cognitive assessments and dementia diagnosis in a period of 9 months, starting after workshop participation of the duos. Secondary outcomes are measured on GP and nurse level: rate of adherence to national guidelines for dementia diagnosis, attitude, confidence and knowledge regarding dementia diagnosis and management; on patient level: number of emergency calls, visits and consultations and patient satisfaction; and on caregiver level: informal caregiver burden and satisfaction. Data will be collected from GPs' electronic medical dossiers, self registration forms and questionnaires. Statistical analysis will be performed by using MANOVA-method. Also, exploratory analyses will be performed, in order to gain insight into barriers and facilitators for implementation and the causal relations between the rate of success of the intervention components and the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* GP and practice or district nurse must participate as a duo

Exclusion Criteria:

* None
Left Ventricular Torsional Hysteresis: A Global Parameter for Diastolic Function

Diastolic dysfunction refers to abnormal mechanical properties of the myocardium and includes abnormal LV diastolic distensibility, impaired filling and slow or delayed relaxation- regardless of whether the ejection fraction is normal or depressed and whether the patient is asymptomatic or symptomatic. Epidemiologic studies have demonstrated high prevalence of diastolic heart failure (DHF). The quality of life of these patients is impaired and the clinical outcomes are similar to those with heart failure with systolic dysfunction. Therefore diastolic dysfunction has significant adverse economic impact that is expected to grow further with time. Clinical characteristics alone may not be sufficient to diagnose diastolic dysfunction. A number of invasive and non-invasive parameters have been proposed to diagnose diastolic dysfunction. Most of the presently used non-invasive parameters have a number of limitations. High fidelity measurement of the left ventricular pressures is needed to accurately diagnose diastolic dysfunction. Obtaining it in routine clinical practice is impractical.

In this protocol the investigators have proposed a novel non-invasive parameter called 'Torsional Hysteresis' as a measure of diastolic function. This will be measured using non-invasive cardiac MRI technique. During left ventricular contraction and relaxation, myocardium deforms. During cardiac cycle the myocardium goes back to baseline state prior to beginning of each contraction. However the rate with which it returns to the baseline state is variable. Torsion indicates relative wringing motion of the ventricle around a left ventricular axis and is a global parameter of left ventricular deformation. The parameters have defined a new parameter called torsional hysteresis based on non invasive cardiac MRI assessment. The parameters have hypothesized that for diastolic dysfunction, the torsional hysteresis area is increased as compared to no diastolic dysfunction group.


Eligibility Criteria:
Inclusion Criteria:

Major inclusion criteria: Normal screening LV ejection fraction.

Exclusion Criteria:

1. Atrial fibrillation or other significant cardiac arrhythmia on ECG
2. Presence of pacemaker or defibrillator
3. Angioplasty or primary coronary intervention PCI/PTCA during index cardiac catheterization.
4. Patient is unable to undergo cardiac MRI due to contraindication to MRI (MRI incompatible metal prosthesis or implants or significant claustrophobia).
5. Patient taking phosphodiesterase 5 inhibitor (eg. sildenafil) will be excluded due to potential interaction with nitroglycerin.
A Phase I Clinical Study of VSA012 in Healthy Volunteers

The complement system is an important component of the innate immune system. Abnormal activation, inadequate regulation and control of the complement system, as well as impaired and dysfunctional effector functions, underlie complement mediated diseases. VSA012 targeting complement system has the potential to treat a variety of diseases associated with abnormal activation of the complement system (e.g. PNH) .The purpose of VSA012-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VSA012 Injection in adult healthy volunteers (HVs). HVs will receive a single dose of VSA012 or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Willing to provide written informed consent and to comply with study requirements
* Participants must be non-pregnant/non-lactating
* Healthy volunteers must be willing to be vaccinated with a meningococcal and pneumococcal vaccine.
* Body Mass Index (BMI) between 18.0 and 30.0 kg/m2
* No abnormal finding of clinical relevance at the Screening evaluation that, in the opinion of the Investigator, could adversely impact participant safety or adversely impact study results.

Exclusion Criteria:

* History of recurrent or chronic infections including infections caused by encapsulated bacterial organisms or viruses
* History of active bacterial, viral, or fungal infection within 14 days prior to treatment administrations
* Seropositive for Human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
* History of meningococcal infection
Physical Therapy for Temporomandibular Joint (TMJ) Closed Lock

The aim of the present study was to investigate the effect of Physical Therapy (PT) on pain and mandibular function in patients with anterior disc displacement without reduction (ADD-R) or "closed lock" of the TMJ and this in a randomized controlled trial design.

The study evaluated the effect of extra, technical PT over the traditional information on the benign nature of the disease and the advice to refrain from overuse or misuse of the masticatory system as in parafunctions.

Eligibility Criteria:
Inclusion Criteria:

* All patients were recruited from the Oral Pain and Dysfunction Clinic and strictly satisfied the RDC-TMD criteria for .for disc displacement without reduction with (group IIb) or without (group IIc) limitation of mouth opening, based upon history and clinical examination. Additionally, pain experienced during the first examination had to be ≥ 35mm on a visual analog scale (VAS) of 100mm.

Exclusion Criteria:

* Patients were excluded if their medical history mentioned orofacial traumata (contusion or fracture), systemic disorders (e.g. rheumatoid arthritis, fibromyalgia), cervical disorders (operationalized as complaints, pain or referral patterns of pain provoked during movements of the cervical spine), neurologic disorders (e.g. trigeminal neuralgia, migraine or tension type headache), drug or alcohol abuse, use of antidepressant or hormonal medication. Participants did not receive therapy for symptoms of TMD within the last 2 months.
Probiotics in the Reduction of Antibiotic Associated Diarrhea

The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in pneumonia patients.

The study will include patients admitted to Good Samariatan Hospital and placed on the pneumonia order set. After obtaining consent, subjects will be randomized to the proboiotic or placebo group. Subjects will be followed for 21 days after starting the study treatment to determine critical outcomes such as incidence of antibiotic-associated diarrhea and C-Diff. Other outcomes include length of stay, healthcare costs, and death.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to Good Samaritan Hospital
* Placed on pneumonia order set
* Age 18+

Exclusion Criteria:

* Patient with inadequate coherency to understand consent
* Active Diarrhea at admission
* Non-controlled intestinal disease
* Documented positive C. difficile infection within the 3 months before enrollment
* Antibiotic use at hospital admission
* Immunosuppressive therapy
* Pregnancy
* Allergic to ingredients in Florajen-3
* Allergic to ingredients in placebo
* Immunocompromised state including:
* HIV with a low CD4 count
* Active malignancy receiving chemotherapy
* Medications including long-term steroids (\>2 weeks), and disease modifying biologic agents
* Acquired immune deficiency
* Unable to take oral medication
* Less than 4 doses of probiotic or placebo
* Taking probiotic in the past 30 days
The Effect of Chemotherapy on Regulatory T Cells

The investigators aimed to study the effect of chemotherapy on regulatory T cells (Tregs) in children with precursor B (PreB) acute lymphoblastic leukemia (ALL) at 15 and 33 days of malignity directed therapy. The investigators will analyze peripheral and bone marrow blood samples of the participants, obtained at diagnosis, 15 and 33 days of treatment, about Treg / non Treg cells and interleukin (IL)-2, IL-6, IL-10, and transforming growth factor (TGF) beta levels. By this means, investigators will search response to chemotherapy. Also, investigators will analyze correlation between Treg population-Treg related cytokines with demographic, clinical and laboratory findings of the participants with ALL at these certain time points. Additionally, the investigators will compare Treg population and minimal residual disease at 15-33 days of malignity directed therapy. Also investigators will compare these Treg-Treg related cytokines obtained from the participants with ALL and a healthy children control group whom are voluntary donors for bone marrow transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Children between 1-18 years
* Recent PreB ALL diagnosis

Exclusion Criteria:

* Children under 1 or over 18 years
* Underlying disease e.g. immune deficiency, germline mutations or diseases
* Tcell ALL or acute myeloid leukemia (AML) patients