cyrilzakka/clinical-trials huggingface dataset:
Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection

Primary objective: To compare the event rate of CDI in groups assigned to ACAM-CDIFF™ vaccine versus placebo in the 9 week period after the third dose of the study vaccine in subjects with first episode of CDI receiving antibiotics standard of care.

Secondary objective: To evaluate the safety of all dose groups of ACAM-CDIFF™ vaccine versus placebo in subjects with first episode of CDI receiving antibiotics standard of care.

This study is designed primarily to obtain information on the preliminary efficacy, safety and immunogenicity of ACAM-CDIFF™ vaccine, as compared to placebo in subjects who are experiencing their first event of CDI and are being treated with the antibiotic standard of care. This study will be conducted in the United States and United Kingdom. Adult subjects with limited chronic disease, who are currently receiving treatment for their first episode of CDI will be enrolled in this trial. Subjects will be required to be able to take oral antibiotics.

Eligibility Criteria:
Inclusion Criteria:

1. Adult subjects, 18 - 85 years old, who understand the risks and benefits of participation and have provided written informed consent for the study.
2. Subjects who are experiencing a first event of CDI diagnosed within the last 10 days.
3. Subjects who are medically stable.
4. Subjects who are willing and able to comply with the study procedures and visit schedules outlined.

Exclusion Criteria:

1. Subjects who are currently on treatment for a recurrence of CDI.
2. Subjects who are currently or have recently been treated with immunoglobulin therapy.
3. Pregnant or breast feeding females.
4. Concurrent, acutely life-threatening diseases.
Prospective Investigation of Oxidative Stress in West Nile Virus Infection

The investigator hypothesizes that oxidative stress responses to West Nile virus infection in the central nervous system determine the severity of infection and the long-term neurological, neuropsychological and functional sequelae of West Nile Neuroinvasive Disease.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent. If the clinical condition of the patient does not permit giving consent, informed consent will be obtained from the next of kin.
* Age 18 years or older
* for active cases: positive anti-WNV IGM antibodies in serum (or IgG in CSF if applicable)
* for active cases: presentation within (maximum) 7days of symptom onset
* for healthy controls: anti-WNV antibody naive (IgM and IgG in serum). The group of healthy controls will be selected to have an age similar distribution to the cases.

Exclusion Criteria:

* Evidence of active systemic infection in 3 months prior to recruitment
* Evidence of systemic inflammatory illness
* Clinical signs of neurodegenerative or neurologic disease other than WNND
* Pregnancy
* Active malignancy
* History of drug abuse
Effect of Manual Therapy on Obese Individuals With Low Back Pain

This study will investigate the effectiveness of Mulligan mobilisation techniques Sustained Natural Apophyseal Glides (SNAGS) and Natural Apophyseal Glides (NAGs) on pain, disability, and range of motion (ROM) in obese individuals with mechanical low back pain (LBP).

One of the most important methods in the treatment of LBP in recent years is manual therapy; manipulation, mobilisation and soft tissue techniques. With the manual techniques applied to the spine, the position and placement of the anatomical structures are changed and the tight and tense tissues are loosened. It has been observed that Mulligan techniques can correct the faults that cause pain in the spine and that the structures that cause pain return to their normal functions when released. In the literature, it has recently been observed that the number of studies examining manual therapy and Mulligan Concept methods has increased. Studies examining the effect of SNAG method on the lumbar region (12) and the effect of mobilisation and taping on chronic low back pain were found. However, no study was found in which SNAG and NAGS applications were applied on obese patients diagnosed with mechanical low back pain. Therefore, in this study, SNAG and NAGS in obese patients with LBP to investigate the effectiveness of the practices

Eligibility Criteria:
Inclusion Criteria:

diagnosed with mechanical low back pain, Body Mass Index (BMI) was between 30.00-39.99, 1.-2. Forty-six patients, aged 20-50 years, who were extremely obese and had pain radiating to the lower back and hips for at least 3 months,

Exclusion Criteria:

-
A Study of Disease Progression and Anti-HIV Treatments

To determine the influence of virus load, CD4 count, biologic phenotype, and presence of symptomatic disease on the response of HIV-infected patients to a new therapeutic regimen. PER AMENDMENT 8/27/96: To extend the availability of currently assigned ACTG 303 treatment for 6 months.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Prior participation on protocol ACTG 175.

PER AMENDMENT 8/27/96:

* Patients must be on study/on treatment at the time the protocol study treatment is extended.
Interaction Effect of Asthma and Aeroallergen Category on the Psychological Status in Allergic Rhinitis Patients

Allergic rhinitis (AR) and asthma are considered as "one airway, one disease". Although there is increasing evidence for an association between allergy and depression, it remains unknown if the relationship between AR and asthma has extra influence on the psychological status of the patients. The aim of our study was to investigate the influence pattern of asthma on the psychological status in AR patients. The Symptom Checklist-90 (SCL-90) was employed to analyze the psychological status of 524 individuals with AR. Independent sample T-tests, one-way ANOVA and multivariate ANOVA were used for data analyses.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffered from rhinitis symptoms such as nasal itching, sneezing, nasal obstruction and running nose, all patients had not undergone any medicine therapy in the past one week; nasal endoscopy showed a pale and edematous nasal mucosa, nasal discharge and swollen inferior turbinates. Every nasal symptom was scored on Visual analog scale (VAS, 0-3 score) respectively. A score of 0 indicated no nasal symptom, 1 indicated slight nasal symptoms, 2 indicated obvious nasal symptom, but which could still be endured, and 3 indicated obvious nasal symptoms that could not be endured;
* Age between 16 to 60 years;
* A positive skin prick test (SPT)to at least one allergen, the level of response equal to or exceeding ++. The following inhalant allergens were tested: Der p; Der f; Animal hair; Trees; Grasses; Cereals; Mugwort; Dandelion; Giant ragweed; Chenopodium album; Humulus; Locust; Blatella germanica; Pine; Plantain; Curvularia lunata; Candida albicans; Penicillium notatum; Alternaria tenuis and Aspergillus fumigatu. The reactions were evaluated based on the mean wheal diameter at 15 minutes after application of the extracts. The mean diameters of each allergen wheals were calculated from the sum of the largest measurement across the wheal and the largest wheal measurement perpendicular to this divided by two. In addition, we calculated the skin index (SI) as the ratio of allergen weal diameter divided by the histamine weal size. The SPT result for each allergen was defined in terms of the SI value as follows: +: SI≤0.5; ++: 0.5\<SI≤1.0; +++: 1.0\<SI≤2.0; ++++: SI\>2.0.

Exclusion Criteria:

* AR combined with hypertension, diabetes or other chronic diseases;
* AR combined with tumor in the nasal cavity;
* AR combined with eczema;
* Acute infection in the past one week;
* Failure to complete the questionnaires;
* AR patients undergoing negative life events.
Supported Employment for Refugees

Humanitarian crises related to the Syrian conflict have led to a large increase in refugees in Europe in the recent years. There is need for effective approaches to increase labor market participation among refugees, and to reduce the impact of unfavorable exclusion mechanisms among this group. The Supported Employment for Refugees (the SER-trial) is a randomized controlled trial investigating the effectiveness of Supported Employment (SE) for newly arrived refugees who are involved in the mandatory introduction program provided for all refugees in Norway. SE is an intervention that has proved effective in promoting competitive employment among patients with severe mental illness in over twenty international randomized controlled trials, and is currently being evaluated for various new patient groups in ongoing trials. The SER-trial is however the first trial to evaluate the effect of SE for the target group of refugees (who may or may not have mental illness).


Eligibility Criteria:
Inclusion Criteria:

* Refugees in the city of Bergen, Norway
* Expressed desire to work
* Able to have a simple conversation in Norwegian or English

Exclusion Criteria:

* No expressed desire to work
* Unable to have a simple conversation in Norwegian or English
Systematic Assessment of Self-help Tools for the Management of Chronic Tinnitus

With this study we want to investigate the impact of self-help tools on the subjective tinnitus distress in chronic tinnitus patients.

Furthermore, we want to investigate the influence of personal characteristics on the individual tinnitus improvement.

A smart-phone app running on iOS devices will be used to give self-help tips to the chronic tinnitus patients.

Eligibility Criteria:
Inclusion Criteria:

* chronic tinnitus, duration at least 6 monhts

Exclusion Criteria:

* acute psychosis, depression, substance abuse
* psychopharmaca
* epilepsy or other disease of the central nervous system
* other tinnitus treatments in the last 3 months
* drug, medication or alcohol abuse in the last 12 weeks
Secondary Intervention and Surveillance After EVAR

This is a retrospective cohort study of consecutive patients submitted to elective EVAR, between February/2009 and May/2019 in a single institution. Symptomatic or ruptured AAA, mycotic aneurysms, isolated iliac aneurysms and complex abdominal aortic repairs were excluded. The primary outcomes were freedom from secondary intervention and compliance with follow-up, defined as surveillance imaging performed within a periodicity no longer than 18 months.


Eligibility Criteria:
Inclusion Criteria:

* This is a retrospective cohort study of consecutive patients submitted to elective EVAR, between February/2009 and May/2019 in a single institution.

Exclusion Criteria:

* Symptomatic or ruptured AAA, mycotic aneurysms, isolated iliac aneurysms and complex abdominal aortic repairs were excluded.
Preferences of Israeli New Physiotherapists in Choosing Their Future Workplace

This study aim to create a multidimensional body of knowledge on the factors influencing physiotherapy graduates in Israel in choosing a workplace, satisfaction with the chosen framework, and intergenerational differences in these factors. In addition, to examine the relationship between the factors for choosing a professional career in physiotherapy and choosing a workplace

The study will be mixed methods and will include: focus groups for the accuracy of the content of the questionnaires (5 students, 5 physiotherapists), a preliminary study to examine the clarity and understanding of the questionnaires (10 students,20 physiotherapists), and a cross-sectional study using online questionnaires to examine workplace preferences and the factors influencing choosing a career in physiotherapy among fourth-year students, young physiotherapists and experienced physiotherapists.

Eligibility Criteria:
Inclusion Criteria:

* physiotherapists

Exclusion Criteria:

-
Diagnosis of Epithelial Ovarian Cancer Using Ovarian Cancer Score (OCS) Test

The study is designed to confirm the performance of the 3D Medicines Corporation OCS test in diagnosis of epithelial ovarian cancer in patients with adnexal mass. To this end, blood samples from female patients with adnexal mass required surgical resection from four centers are obtained and analysis in the study.


Eligibility Criteria:
Inclusion Criteria:

* a) ≥ 18 years of age;
* b) Patients with adnexal masses;
* c) Sign the informed consent form;
* d) Adnexal mass that requires excision;

Exclusion Criteria:

* a) history of chemoradiotherapy;
* b) history of malignancy;
* c) pregnancy;
* d) Adnexal mass not require surgical excision;
* e) The adnexal mass has been diagnosed as malignant before surgery, and the number of cases enrolled in a single institution exceeds 50;
* f) Blood CA125 value greater than 1000 U/ml at initial treatment.
IL-11 in Adults With Von Willebrand Disease Undergoing Surgery

The purpose of this study is to determine the efficacy and safety of rhIL-11 when given subcutaneously in adults with type 1 von Willebrand disease undergoing elective surgery or major dental procedure. Efficacy will be measured by estimated blood loss, and frequency and severity of bleeding and transfusion requirement during and after surgery. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.

This study is a prospective, single-center Phase II trial of Neumega (rhIL-11) in adults with type 1 VWD undergoing elective surgery or major dental procedure. It is anticipated that 10 subjects who meet eligibility criteria will enroll and complete the study. The specific objectives are to determine the efficacy and safety or rhIL-11 during and after elective surgery, and to determine the mechanism of the hemostatic response of rhIL-11.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years of age and older
* Confirmed type 1 VWD, as defined by low VWF:RCoF or low VWF:Ag and qualitatively normal VWF multimers
* A past bleeding history
* Responsive to DDAVP
* Scheduled elective major surgery or major dental surgery at MUH or PUH
* Willingness to have blood drawn

Exclusion Criteria:

* Presence of other bleeding disorders, acquired Von Willebrand disease, primary thrombocytopenia
* Use of immunomodulatory or experimental drugs, or diuretics
* Pregnant or lactating women or those unwilling to use contraception during study
* Previous cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation, atrial flutter), hypertension, MI, stroke, or thrombosis
* Past allergic reaction to Neumega or DDAVP
* Surgery within the past 8 weeks
* Inability to comply with study protocol requirements
* Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs
* Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or VWF within five days of study
* Past allergic reaction to Neumega or DDAVP
* Surgery within the past 8 weeks
* Inability to comply with study protocol requirements
* Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs
* Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing substantial quantities of FVIII and/or VWF within five days of study
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1

This trial investigates the effects of FE 999049 compared to GONAL-F.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent Documents signed prior to screening evaluations
* In good physical and mental health
* Pre-menopausal females between the ages of 18 and 40 years
* Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor
* Infertility for at least one year before randomisation for subjects ≤37 years or for at least 6 months for subjects ≥38 years (not applicable in case of tubal or severe male factor infertility)
* The trial cycle will be the subject's first controlled ovarian stimulation cycle for IVF/ICSI
* Hysterosalpingography, hysteroscopy, saline infusion sonography, or transvaginal ultrasound documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) within 1 year prior to randomisation
* Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality (e.g. no endometrioma greater than 3 cm or enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) within 1 year prior to randomisation. Both ovaries must be accessible for oocyte retrieval.
* Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to randomisation)
* Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening

Exclusion Criteria:

* Known endometriosis stage III-IV
* One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to randomisation on stimulation day 1
* Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy (excl. ectopic pregnancy) and before week 24 of pregnancy)
* Known abnormal karyotype of subject or of her partner/sperm donor, as applicable, depending on source of sperm used for insemination in this trial.
* Any known clinically significant systemic disease (e.g. insulin-dependent diabetes)
* Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial with the exception of controlled thyroid function disease
* Known tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
Epidural Neuroplasty for the Treatment of Herniated Lumbar Disk

The purpose of this study is to determine whether epidural neuroplasty has better efficacy than epidural steroid injection for the treatment of lumbar disc herniation.

One hundred patients diagnosed as herniated lumbar disc will be recruited and divided into two groups. One group will be treated with Transforaminal steroid injection, the other with epidural neuroplasty. The VAS and ODI scores obtained at one month, three months and six months post-treatment will be analysed statistically.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of herniated lumbar disc
* written informed consent obtained

Exclusion Criteria:

* Lumbar instability
* Piriformis syndrome
* Diabetes mellitus with uncontrolled blood glucose
* Severe osteoporosis
* Impaired function of cauda equina
* Severe sacral hiatus variation
* Interspinous ligament inflammation
* Myofascitis on lumbar and legs
* The third lumbar transverse process syndrome
Anti-CTLA-4 Human Monoclonal Antibody CP-675,206 in Patients With Advanced Hepatocellular Carcinoma

CP-675,206 (tremelimumab) is a fully humanized monoclonal antibody that binds to activated T lymphocytes and by enhancing their activation may produce a stimulation of the immune response against tumoral or viral antigens. In this clinical trial, the ability of tremelimumab to produce tumor responses among hepatitis C virus-infected patients with hepatocellular carcinoma not amenable to other therapies will be explored. Besides, the effect on the replication of the virus will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* Unequivocal diagnosis of HCC
* unresectable disease not amenable to locoregional treatment.
* a 4-week washout period after sorafenib or any other systemic agent
* a 2-month washout period after internal or external radiation
* HCV chronic infection
* Child-Pugh stage A or B
* Measurable disease according to RECIST criteria
* ECOG \< 2
* expected survival \> 3 months
* Adequate liver, renal and blood functions
* ability to sign informed consent

Exclusion Criteria:

* previous treatment with an anti-CTL-4 agent
* serious infections or disease compromising general health status
* autoimmune disease that requires therapy
* treatment with immunosuppressors
* treatment with investigational agents
* other neoplasms except skin and bladder superficial tumors
* pregnancy or lactation
* SNC metastasis
* HIV infection
* relevant heart disease (NYHA class III or IV)
Intensive Monitoring Scheme of Lidocaine Cataplasms

In this center, retrospective research methods are used to collect data. Patients who had used Lidocaine Cataplasms at least once were included consecutively. Taking the time when the patient first used Lidocaine Cataplasms as the starting time (the study baseline), collect the demographic characteristics of the patient, the medication scheme of Lidocaine Cataplasms and other information, as well as the medication safety and other information from the first medication to the end of medication or discharge (whichever occurs first).


Eligibility Criteria:
Inclusion Criteria:

* All patients receiving Lidocaine Cataplasms from January 1, 2021 to April 1, 2022.

Exclusion Criteria:

* Unable to obtain complete medication information.
Clevidipine in the Postoperative Treatment of Hypertension (ECLIPSE-NIC)

The purpose of this study is to establish the safety of clevidipine in the treatment of postoperative hypertension. Approximately 250-500 patients with postoperative hypertension after undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or nicardipine.

The primary objective was to establish the safety of clevidipine in the treatment of postoperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and nicardipine treatment groups from the initiation of study drug infusion through postoperative Day 30. Secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (BP) lowering effect, and additional safety variables.

Eligibility Criteria:
Prerandomization Inclusion Criteria:

* Provide written informed consent before initiation of any study related procedures.
* Be at least 18 years of age
* Be scheduled for Coronary Artery Bypass Grafting (CABG), Off Pump Coronary Artery Bypass (OPCAB), Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) surgery, and/or valve replacement/repair surgery

Prerandomization Exclusion Criteria:

* Women of child-bearing potential (unless they have a negative pregnancy test)
* Recent cerebrovascular accident (within 3 months before randomization)
* Known intolerance to calcium channel blockers
* Known or suspected hypersensitivity to nicardipine
* Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
* Pre-existing permanent ventricular pacing
* Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial
* Participation in another therapeutic drug or therapeutic device trial within 30 days of starting study

Postrandomization Inclusion Criteria:

* Expected to survive beyond 24 hours post-surgical procedure
* No surgical complications or conditions, present or anticipated, that preclude them from inclusion in the study
* Determined to be hypertensive postoperatively as determined by the investigator