cyrilzakka/clinical-trials huggingface dataset:
Effect of Spinal Manipulation on Experimental Pain in Asymptomatic Subjects.

Spinal manipulation is often used for its effect on pain, but more information is needed concerning its mechanisms of action.

The effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects should be challenged by a validated sham procedure, regionally and remotely over time. Further information is needed concerning its duration and its size.

Research questions:

1. What is the regional effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
2. What is the remote effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects, when compared to a valid sham procedure?
3. What is the duration of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects?
4. What is the size of the effect of spinal manipulation on the pressure pain threshold in asymptomatic subjects over time?

Eligibility Criteria:
Inclusion Criteria:

* The subjects must be young (18-30 years old)
* asymptomatic (no pain in the tested area, but the study accepts pain elsewhere, as long as it is less than 1/10 on the BOX-scale).
* Chiropractic students.

Exclusion Criteria:

* The subjects must not be reporting any spinal pain lasting more than a month
* and/or having taken painkillers 24h prior to the study.
* Contra-indications to the spinal manipulation (instability, fracture, malformation, bone or ligament fragility, and inflammations).
AZD2014 and Fulvestrant in Patients With ER+ Advanced Metastatic Breast Cancer

The purpose of this study is to assess safety and tolerability of AZD2014 when given in combination with Fulvestrant

A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination with Intramuscular (IM) Fulvestrant to Patients with Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated written informed consent prior to any study specific procedures, sampling analysis
* Aged at least 18
* At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (CT) magnetic resonance imaging (MRI) or plain X-ray and is suitable for repeated assessment
* Histological or cytological confirmation of an ER+ advanced metastatic breast cancer tumour that is eligible for treatment with fulvestrant
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patients must have evidence of non-child-bearing potential.

Exclusion Criteria:

* Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 14 days of starting study treatment (not including palliative radiotherapy at focal sites)
* Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study.
* Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions.
* Patients with diabetes type 1 or uncontrolled type II (HbA1c \> 8% assessed locally)
The Effect of American Ginseng Root and Its Components on Glycemia in Healthy Individuals

To determine the effect of polysaccharides from American ginseng root on postprandial glycemia in healthy individuals.

Glycemia-lowering effects of American ginseng root have been repeatedly observed in healthy individuals and in type 2 diabetes. It is unclear which components trigger these effects. Pre-clinical evidence suggests that, aside from ginseng saponins, ginseng polysaccharides may reduce glycemia. This assumption has not been investigated so far in humans.

We therefore undertook a double-blind randomized controlled clinical trial to determine the effect of American ginseng root polysaccharides, at escalating doses, on postprandial glycemia, in comparison to the American ginseng root and control in healthy individuals. We hypothesized that polysaccharides will reduce glycemia comparably to a dose of ginseng root that contains polysaccharides at an equivalent amount to the average polysaccharide dose. We therefore tested polysaccharide doses equivalent to 9, 12 and 15 g of rot, 12 go of ginseng root and a wheat bran control. Each subject received each treatment in random sequence, after a 12-hour overnight fast and 40 minutes prior to a 25-g oral glucose tolerance test. Capillary blood samples were collected at baseline, prior to glucose ingestion and at 15, 30, 45, 60, 90, 120 minutes after the start of glucose intake. Capillary blood glucose was measured.

Eligibility Criteria:
Inclusion Criteria:

* 16-65 years old
* normal renal and hepatic function
* fasting plasma glucose: 4-6 mmol/l
* clinically euthyroid
* normotensive

Exclusion Criteria:

* pregnant
* taking herbs, supplements or medication that affect glycemia
* major illnesses/ disease
* heavy alcohol use (\> 3 drinks/ day)
* heavy smoking (\> 10 cigarettes/ day)
Light Sedation or Intubated General Anesthesia in Patients With Brain Cancer Undergoing Craniotomy

This randomized clinical trial studies light sedation compared with intubated general anesthesia (a loss of feeling and a complete loss of awareness that feels like a very deep sleep) in reducing complications and length of hospital stay in patients with brain cancer undergoing craniotomy. Craniotomy is an operation in which a piece of the skull is removed so doctors can remove a brain tumor or abnormal brain tissue. Light sedation allows patients to remain awake during their surgery, while intubated general anesthesia puts patients to sleep. Surgery complication rates may be reduced if intubated general anesthesia is avoided. Additionally, patients not receiving intubated general anesthesia tend to recover more quickly after surgery. It is not yet known whether light sedation is better at reducing complications and length of hospital stay compared to intubated general anesthesia.

PRIMARY OBJECTIVES:

I. To compare the overall hospital length of stay (LOS) in patients undergoing craniotomy with light sedation vs. general anesthesia.

SECONDARY OBJECTIVES:

I. To compare resource utilization between the two groups. II. To assess the frequency of post-operative delirium. III. To measure patient perceptions. IV. To track patient complications during hospital stay - nausea/vomiting, pain, hematology/lab stability, hemodynamic stability.

V. To track re-admission and extended hospital stay rates. VI. To compare cost of both approaches.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive light sedation (awake) and undergo craniotomy.

ARM II: Patients receive intubated general anesthesia and undergo craniotomy.

After completion of study, patients are followed up at 1month and 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant females
* Elective craniotomy for supratentorial brain tumors
* Primary brain cancer (presumed gliomas with no radiographic or clinical evidence of metastatic disease to the brain)
* First craniotomy
* American Society of Anesthesiologists (ASA) I-III
* Body mass index (BMI) \< 35

Exclusion Criteria:

* Posterior fossa tumor/approach for tumor resection requiring the prone position
* Traumatic lesions/hematomas
* Emergency case
* Systemic disease burden with metastatic tumor to the brain
* Presence of medical co-morbidities, which, in the opinion of the investigator complicates the surgical procedure or would require additional hospital stay
* Necessity of awake procedure requiring intraoperative participation of patient due to the presence of the lesion in eloquent brain areas
* Prisoners
* Pregnant women
Eliminating Hepatitis C Virus

Initially, HCV Informatics (C-IT) will be used to filter the EMR data of the one million people who receive care at Mount Sinai and identify candidates for HCV testing (baby boomers, patients with HIV infection) and candidates for HCV treatment (patients with positive test results for HCV RNA and no record of treatment).once treatment candidates have been identified through this proactive approach, their providers will be directly notified. HCV champions and patient navigators will be used to further lower barriers to the delivery of HCV care. They will be co-located at non-hepatology care sites and will help deliver open-label HCV treatment as part of standard medical care to 500 HIV/HCV co-infected patients and 200 patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for HCV treatment in patients with HIV/HCV co-infection

* 18 years of age or older
* HCV RNA positive
* Any HCV genotype
* Documented infection with HIV, with the following additional criteria: - Patients on HAART should be on a stable regimen for 4 weeks, with a CD4 count \> 100, and an HIV viral load \< 50 prior to initiation of HCV therapy Patients not on HAART should have a CD4 count \> 350
* Expected life expectancy sufficient to receive a benefit from HCV cure
* No conditions that are contraindications for the use of HCV medications

Inclusion criteria for HCV treatment in patients with type 2 diabetes

* 18 years of age or older
* HCV RNA positive
* Any HCV genotype
* Documented diagnosis of type 2 diabetes, confirmed by medical record review by the study endocrinologist, Dr. Sherley Abraham
* Expected life expectancy sufficient to receive a benefit from HCV cure

Exclusion Criteria:

* No conditions that are contraindications for the use of HCV medications
Anti-shivering Effect of Ondansetron

Shivering is one of the most frequent complications occurring during or after spinal anesthesia with many side effects. The aim of the present study was to compare between two different doses of ondansetron for anti-shivering effect

Shivering is one of the most frequent complications occurring during or after spinal anesthesia, it affects about 40%-60 % of patients under spinal anesthesia. Intra and Post spinal shivering is distressing for the patients and anesthetist. Shivering may aggravate medical conditions in patients with limited cardiac or respiratory functions. It increases tissue oxygen demand many folds which in turn leads to increase the load on respiratory and cardiac systems to cope with increased aerobic metabolism. Shivering interferes with good patient monitoring by causing artifacts of electrocardiography, invasive and non-invasive blood pressure, pulse oximetry, etc... . Postoperatively shivering may cause discomfort to the patient, increases wound pain by stretching incision, increase the incidence of bleeding and infection.

We aim to compare the prophylactic use of two different doses of ondansetron on the incidence of shivering after spinal anesthesia in patients scheduled for lower limb surgery.

The primary outcome was percentage of patients suffering from shivering after spinal anesthesia, secondary outcomes include any side effects related to both doses.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-65 years
* Both sexes
* American Society of Anesthesiologists
* physical status I and II
* scheduled for lower limb surgery under spinal anesthesia

Exclusion Criteria:

* Uncooperative patients
* psychologically unstable patients
* obese patients with BMI \>30 preoperative use of ondansetron, or opioids Fever Patients with some clinical conditions like hypo- or hyperthyroidism, Parkinson's disease.
Assessment of Serum and Tissue Tryptase Levels in Acne Vulgaris Patients

Acne vulgaris is an inflammatory disorder of pilosebaceous glands. Acne is a highly prevalent inflammatory disease affecting approximately 9.4% of the world's population , and estimated up to 90% among adolescents. By natural course acne starts at 7-12 ages and mostly resolves by the third decade of individuals life .

Mast cells may play important role in maintenance of physiological functions of our body; they also have a role in pathological and inflammatory mechanisms of many diseases. Tryptase is suggested to be important for survival as no tryptase-deficient human subject has yet been reported. Tryptase is mainly synthesized by mast cells but a very low amount may originate in basophil with no interference with total levels of the enzyme. Tryptase is currently considered as a metabolic signaling and effector mediator for acute mast cell degranulation and late phase of allergy and inflammation .


Eligibility Criteria:
Inclusion Criteria:

* Patients with acne vulgaris ≥ 18 years old, both male and female patients will be included.

Exclusion Criteria:

* Patients with the following criteria will be excluded from our study: 1- Pregnancy and breast feeding women. 2- Women on hormonal contraceptions. 3- Patients on topical/systemic treatment for AV during the last 6 months prior to the study. 4- Patients with other dermatological diseases e.g. psoriasis, vitiligo, DLE, etc. 5- Patients suffering from chronic medical illness such as; diabetes mellitus, thyroid disease, and cancer.
A Study to Evaluate Psoriasis Outcomes and Safety Events in Patients With Chronic Moderate to Severe Plaque Psoriasis (RESPONSE)

This was a multicenter, prospective, 5-year surveillance study of approximately 5000 Raptiva-treated patients and approximately 500 non-Raptiva treated patients (formerly 2500 comparison patients who were treated with a biologic therapy other than Raptiva) with chronic moderate to severe plaque psoriasis who were candidates for treatment with Raptiva.


Eligibility Criteria:
Inclusion Criteria:

* Have ever had a physician's diagnosis of chronic moderate to severe plaque psoriasis and be a candidate for treatment with Raptiva
* Are being treated with or initiating Raptiva therapy at the time of enrollment
* Be able to provide written informed consent
* Be willing and able to fully to participate for the duration of patient follow-up (5 years)

Exclusion Criterion:

* Have previously received at least one dose of Raptiva and are not currently using or restarting treatment with Raptiva at the time of enrollment
Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).

This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month cross-over, dispensing study comparing the test lens against the stenfilcon A control lens with a study duration of approximately two months.

Each subject will be randomized to wear either the test or control as a matched pair first and subjects will be randomized based on the order in which the subject is enrolled and qualified into the study.

Eligibility Criteria:
Inclusion Criteria:

* A person is eligible for inclusion in the study if he/she:

  * Has had a self-reported oculo-visual examination in the last two years.
  * Is at least 18 years of age and has full legal capacity to volunteer.
  * Has read and understood the information consent letter.
  * Is willing and able to follow instructions and maintain the appointment schedule.
  * Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
  * Must achieve 20/30 or better (in each eye) with study lenses
  * Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps).
  * Has no more than 0.75 diopters of refractive astigmatism.
  * Currently wears soft contact lenses.
  * Have clear corneas and no active ocular disease.
  * Has not worn lenses for at least 12 hours before the examination

Exclusion Criteria:

* A person will be excluded from the study if he/she:

  * Has never worn contact lenses before.
  * Has any systemic disease affecting ocular health.
  * Is using any systemic or topical medications that will affect ocular health.
  * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  * Is aphakic.
  * Has undergone corneal refractive surgery.
  * Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
  * Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.
Hypertension in Management of Military Medicine

This study is a retrospective database review of primary care appointments of patients' charts with new diagnoses of hypertension.

Compare the degree of blood pressure control of patients with stage 1 (BP \< 130/80 mmHg) and stage 2 hypertension (BP \> 20/10 mm Hg above goal BP) before and after the release of the Seventh report of Joint Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7) recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed hypertension
Clinical Study of Patients Treated With PuraBond Haemostatic Agent During Abdominal Aorta Open Repair

Purabond Study is a physician-initiated, observational, monocentric prospective Trial.

The aim of the study is to investigate the hemostatic efficacy of PuraBond for aortic anastomoses and suture lines in patients with abdominal aortic pathology (aneurysmal or steno occlusive disease) candidate to open repair at Vascular Surgery Departement - San Raffaele Hospital (Milan, Italy). The Study will include 100 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ≥ 18 years of age, presenting with an abdominal aortic aneurysm (pararenal, juxtarenal, infrarenal, aorto-iliac mono/bilateral)
* Use of the Purabond hemostatic agent in patients who, in the opinion of the Physician, don't have a satisfactory surgical haemostasis
* Patients ≥ 18 years of age with steno-occlusive abdominal aortic or iliac disease
* Patients that will treated by open repair , encompassing elective, urgent and emergency presentation, hospitalized and enrolled in Vascular Surgery Unit, San Raffaele Hospital (Milan, Italy)
* Patients able to sign specific informed consent for the study

Exclusion Criteria:

* Patients whom exhibited preoperative derangements in haematological and coagulation profiles, and baseline derangements in liver function
* Patients with abdominal aortic and/or iliac arteries disease candidate for endovascular treatment
* Pregnant, breastfeeding, or planning on becoming pregnant within 24 months
* Systemic infection (for example: sepsis)
* Impossibility or refusal to give informed consent
Effects of Probiotics on Streptococcus Mutans ve Lactobacillus Spp

To evaluate the change of S. mutans and Lactobacillus spp. counts after all dental treatments were completed under general anesthesia and compare the groups in case of using probiotics and not using probiotics with the time for 6-months follow-up period.

Fifthy-eight pediatric patients without any systemical diseases whose dental treatments were completed under general anesthesia were included in the study. The study was carried out as two-groups; Group A: Patients who started using probiotics after general anesthesia and Group B: Patients who did not use probiotics after general anesthesia. The counts of S. mutans and Lactobacillus spp. were determined by quantitative polymerase chain reaction (qPCR) by analysis of saliva samples taken from all patients on the day before the general anesthesia (T0), at 1-month (T1), 3-month (T2) and 6-month (T3) follow-up periods. The statistical significance level was accepted as p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Every included child had at least 8 tooth with caries.

Exclusion Criteria:

* Patients who would not be able to give saliva samples due to high anxiety or lack of saliva were not included in this study.
Bile Usefulness for Detecting IgG4-related Sclerosing Cholangitis

Immunoglobulin G4-related disease (IgG4-RD) is an uncommon inflammatory disorder that may affect multiple organ systems, including the biliary tree. IgG4-sclerosing cholangitis (IgG4-SC) can be difficult to distinguish from primary sclerosing cholangitis (PSC) or cholangiocarcinoma (CCA). The investigators aim to evaluate the sensitivity and specificity of bile for the diagnosis of IgG4-SC. Bile samples of patients with biliary strictures of various causes, including IgG4-SC, PSC, and CCA, will be collected during clinical cholangiography procedures. IgG4 will be measured in bile specimens and bile IgG4 concentrations compared between IgG4-SC, PSC, CCA, and other types of biliary strictures.

This study will recruit cases from Mayo Clinic Rochester and Japanese institutions such as Nagoya City University Hospital, Nagoya Daini Red Cross Hospital, and Kurashiki Central hospital. Participants will be individuals who will receive endoscopic retrograde cholangiography (ERC), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) or percutaneous transhepatic cholangiography (PTC). Bile samples collected from the target cases will be assayed for IgG4 concentration.

Eligibility Criteria:
Inclusion Criteria:

* The presence of a biliary stricture
* 18 years and older
* Consented to IRB 707-03

Exclusion Criteria:

* Younger than 18 years of age
* Unable to collect a bile sample
* Abnormal postsurgical anatomy preventing collection of a bile sample
Respiratory Health Study of Children in Kiryat Tivon

Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon.

The health status will be evaluated using health questionnaires and spirometry.

Kiryat Tivon is located close to a major industrial zone. The aim of the study is to evaluate the health status of children living in K. Tivon.

The health status will be evaluated while using health questionnaires and spirometry.

Objective: To evaluate the respiratory health of K. Tivon children with comparatives, with respect to local air pollution levels.

Material and Methods: All the school children from K. Tivon (1800 children) will be included in the study, after both parents and the children (above 12 years of age) will sign an informed consent form.

First step: A health questionnaire (based on Hebrew version of ISAAC questionnaire) will be filled in by the parents.

Second step: Spirometry checking of the children.

In parallel, air pollution levels will be measured and provided by a network of ground monitoring stations maintained by the Haifa District Municipality Association for the Environment (HDMAE). The station provides half-hourly measurement of mean concentrations of gaseous (NOX, SO2, O3) and particular (PM 10) pollutants over the entire investigation window. Additional meteorological data are also collected.

Risk maps: Using a GIS platform, we are developing a multi-layer risk mapping procedure which accounts for ambient concentrations of selected pollutants and the heterogenic spatial distribution of several demographic and socio-economic indexes in the region.

The prevalence of pulmonary disease will be evaluated according to the risk maps.

Eligibility Criteria:
Inclusion Criteria:

* All school children

Exclusion Criteria:

* Children that their parents did not signed the informed consent