cyrilzakka/clinical-trials huggingface dataset:
A 1-Year Study On The Effects Of CP-945,598 For The Treatment Of Obesity In Overweight Type 2 Diabetic Patients

The purpose of this study is to determine if CP-945,598 is effective in the treatment of obesity in type 2 diabetic patients.

The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be overweight (BMI 27- 50 kg/m2)
* Subjects must have type 2 diabetes mellitus

Exclusion Criteria:

* Pregnancy
* Serious or unstable current or past medical conditions
PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE

The primary goal of the PRAISE study is to develop a diagnostic algorithm that allows the prediction of acute coronary syndrome in stroke patients with elevated levels of cardiac troponin.

Elevation of cardiac troponin can be found in about 30% of patients with acute ischemic stroke (depending on the assay used). Elevated troponin indicates increased mortality in stroke patients. There is currently little evidence regarding the ideal care of these patients. The investigators know from previous studies that approximately 25% of acute stroke patients with elevated levels of cardiac troponin have culprit lesions on coronary angiogram.

The primary goal of the PRAISE study is to develop a diagnostic algorithm that allows the prediction of acute coronary syndrome in stroke patients. To achieve this, clinical symptoms, troponin levels as well as findings on EKG, echocardiography and coronary angiography will be systematically evaluated. The PRAISE study is a multicenter study with more than 20 sites in Germany. Joint funding will be provided by DZHK (German center of cardiovascular research) und DZNE (German center of neurodegenerative diseases). Acute ischaemic stroke patients with elevated troponin are eligible for participation in the study. The primary endpoint is the diagnosis of acute coronary syndrome as established by an independent endpoint committee.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of ischemic stroke based on clinical and imaging information (CT or MRI)
* diagnosis of transient ischemic attack if the initial focal neurological deficit has been examined by a neurologist and if the ABCD2-score is ≥ 4
* Elevation of high-sensitive cardiac troponins according to the rule-in/rule-out algorithm of the 2015 ESC guidelines for NSTE-ACS, i.e. highly abnormal troponin at 0 hours (\> 52ng/l if hs-cTnT, Elecsys-Assay, or \> 52ng/l, if hs-cTnI; Architect-Assay, or \> 107 ng/l, if hs-cTnI. Dimension Vista Assay) or dynamic change \> 20% of the initial value at re-test after 3 hours with at least one value above the 99th percentile of a healthy reference population
* ability to give informed consent
* onset of symptoms \< 72 hours prior to hospital admission

Exclusion Criteria:

* renal insufficiency (GFR \< 30 ml/min/m²)
* contraindications for coronary angiography (e.g. manifest hyperthyroidism, allergy to contrast agent)
* lesion size \> 100 ml (either on Diffusion Weighted Imaging on cMRI or on CT if CT is performed \> 24 hours after onset) or ASPECTS score \< 7 (on CT if CT is performed \< 24 hours after onset)
* Premorbid degree of dependence (mRS \> 3)
* pregnancy or breast-feeding
* limited life expectancy \< 1 year
* consent to participate in the study given \> 72 hours after hospital admission
Influence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial

the study was to evaluate the effect of intra-canal cryotherapy on post-endodontic pain and interleukin-6 expression in teeth with symptomatic apical periodontitis using different irrigation protocols.


Eligibility Criteria:
Inclusion Criteria:

* Anterior or premolar single canal in single rooted teeth.
* Patients aged 20 to 50 years.

Exclusion Criteria:

* Patients under anti-inflammatory medication, immune-suppressive chemotherapy or any antibiotic medication for the last 2 months.
* Pregnant or lactating females.
* Teeth with endo-perio lesions.
Study of an Implantable Device for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery

The purpose of this study is to evaluate the safety and efficacy of the CyPass Implant for lowering intraocular pressure (IOP) in patients with glaucoma who undergo cataract surgery.

This study is a modified and expanded protocol based on acceptable safety results from an earlier feasibility study. The trial is conducted using a 3:1 randomization (treatment to control) in which patients are screened for eligibility, randomized at time of surgery and followed for 24 months postoperatively.

Eligibility Criteria:
Preoperative Inclusion Criteria:

* Diagnosis of primary open angle glaucoma (POAG)
* Mean diurnal unmedicated IOP of 21 - 33 mmHg
* Normal anterior chamber angle anatomy at site of implantation
* Operable age-related cataract

Exclusion Criteria:

* Use of more than 3 ocular hypotensive medications (combination medications count as 2 medications)
* Significant risk associated with washout of ocular hypotensive medication
* Previous glaucoma surgery (with exception of laser treatments to the trabecular meshwork)
* Previous corneal surgery
* Clinically significant ocular pathology, other than cataract and glaucoma
* Diagnosis of acute angle closure, traumatic, congenital, malignant, uveitic, pseudoexfoliative, pigmentary or neovascular glaucoma
Pilot Introduction of Oral Cholera Vaccine in Orissa, India

The purpose of this study is to provide evidence for policymakers and key opinion leaders on the pilot implementation of cholera vaccination using the newly licensed Oral Cholera Vaccine (OCV) in India. The pilot introduction will provide the evidence for the feasibility, costs and population acceptance of large-scale cholera vaccination using the Indian vaccine (using vaccination coverage rates and other measures).

Severe diarrhoeal disease caused by Vibrio cholerae O1 and O139 has long been an important cause of mortality and morbidity in India. The availability and recent licensure of the modified bivalent killed whole cell OCV in India provides hope that the disease may be controlled in areas where the disease is a problem. On April 10, 2009, a meeting was organized by the Indian Council of Medical Research (ICMR), the Department of Biotechnology and the IVI. The recommendations from the meeting are as follows:

* As the modified WC vaccine is safe, effective, and cost-effective, it was suggested that the National Technical Advisory Group on Immunization (NTAGI) should consider recommending introduction of the vaccine in public health programs targeted to appropriate populations in India.
* Vaccination should be initiated in selected highly endemic and/or slum areas such as known areas in West Bengal or Orissa. The pilot vaccination programs will be monitored and evaluated. Further expansion to other areas and wider policy changes will be made in a step-by-step fashion based on the pilot programs. Logistical and operational issues need to be defined.

The aim of the study is to conduct a pilot introduction of the modified killed oral cholera vaccine in a public health setting in a population of \~50,000 before implementing in a larger scale.

Primary objective:

To determine the feasibility, acceptability and costs associated with pilot introduction of the modified killed whole cell oral cholera vaccine in India when given in a public health setting.

Secondary objective:

To identify challenges to mass oral cholera vaccine implementation.

Eligibility Criteria:
Inclusion Criteria:

* aged 12 months and older
* non-pregnant

Exclusion Criteria:

* age less than 12 months
* pregnant
* too ill/old to get out of bed
Effect of Cervical Traction on Balance in Cervical Radiculopathy Patients

A cross-over randomized trial aiming to assess the immediate effect of cervical traction on balance disorders among patients with common cervical neuropathy. Authors hypothesized that as cervical traction alleviate radicular pain it may also improve patient balance disorders. Effective traction is compared to sham traction.

Main outcome measures are balance parameters (force platform).

A cross-over randomized trial was designed to assess the immediate effect of cervical intermittent traction on balance disorders among patients diagnosed with common cervical neuropathy. The diagnosis is confirmed or made by a physical medicine and rehabilitation physician with 15 Y of experience treating musculoskeletal disorders especially cervical neuropathy. Enrolled patients are randomly assigned to one of two arms (1 or 2). Patients in arm 1 (Effective Traction/Sham Traction) are treated firstly with effective traction than one week later with sham traction. Patients in arm 2 (Sham Traction/Effective Traction) are treated firstly with sham traction than one week later with effective traction. At baseline the epidemiological parameters, the pain intensity (VAS), the grip strength, the functional status (NDI), the psychological distress (HAD), the Brief Best Test and the balance parameters (force platform) are assessed. The pain intensity, the grip strength and the balance parameters are assessed before and immediately after cervical traction for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral cervical radiculopathy of greater than three months

Exclusion Criteria:

* History of surgery or bone-ligament damage to the cervical spine
* Neurological and/or rheumatic diseases involving the cervical spine or which may result in impaired balance
* Inner ear and vestibular pathology
* Worsening of pain or intolerance in the manual cervical traction test
Short Term Outcomes of Fracture Odontoid Management

The aim of this study is to evaluate and assess the short-term outcomes of odontoid fracture cases admitted to trauma unit of Assiut university hospital.

patients with completed records, CTs, and Plain radiographs. Sufficient clinical records with documented NDI, The patient will be evaluated in 2 weeks, 6 weeks , and 3 , 6 months post operative .

Eligibility Criteria:
Inclusion Criteria:

* all patients with odontoid fractures admitted to Assiut University Hospital - Department of Orthopedics and Trauma between October 2021 and June 2023

Exclusion Criteria:

* patients who are not available for 6 months follow-up and those with insufficient documentation or records
Anrotinib in Combination With Capecitabine in Advanced Triple Negative Breast Cancer

The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.

It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer

It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer.

The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.

Eligibility Criteria:
Inclusion Criteria:

1. Female aged between 18 and 70;
2. Recurrence or metastasis OF TNBC confirmed by histological or cytological methods, TNBC definitions of ER, PR and HER-2 are negative, if there is metastasis pathology, the histological pathology of metastasis shall prevail.ER and PR negative were defined as ER \< 10% positive and PR \< 10% positive.
3. Disease progression after at least one prior systemic treatment and anthracycline and/or taxane use;Note: For neoadjuvant/adjuvant therapy, recurrence or disease progression during treatment or within 6 months of discontinuation of treatment should be counted as first-line systemic treatment failure;
4. There should be at least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1)

Exclusion Criteria:

1. The number of previous treatment lines (including postoperative adjuvant therapy) \>4 lines
2. symptomatic central system metastases.Patients with stable asymptomatic BMS who have received brain radiation and who have at least one other evaluable target in addition to the BMS can be enrolled (evaluable target should be at least 4 weeks away from the last radiotherapy).
3. New bisphosphonate or dinoselmer treatment for bone metastases was initiated within 28 days prior to study initiation.(Subjects are permitted if they have already been treated with bisphosphonate or dinoselmer for at least 4 weeks of optimal stable administration prior to study initiation.)Subjects already enrolled in this study may begin treatment with bisphosphonate or dinoselmer for bone metastases after the first post-treatment evaluation
Serology and Other Immunologic Response Tests in the Diagnosis of COVID-19 in Pediatrics

Despite the SARS-CoV-2 virus being present worldwide, and although it is now clear that children are affected by the disease with milder symptoms than adults, many immunological questions, which are very relevant for Public Health reasons and for the organization of services, remain unsolved. The role of serology for the diagnosis of COVID-19, particularly in the pediatric age, is still very uncertain. Preliminary evidence suggests that not all children with SARS-Cov-2 infection develop antibody levels that can be detected by currently employed methods. This makes it crucial to identify other methodologies that are able to evaluate the true prevalence of prior SARS-CoV-2 infection in the pediatric population. Many other aspects of the immunological mechanisms of response to SARS-CoV-2 are also uncertain, such as the role of cellular immunity, and generally the role of immunity (cellular and antibody) in protecting against the disease in the medium and long term. Finally, questions remain open regarding cross-immunity with other previously circulating coronaviruses and their impact on the pediatric population in terms of protection against COVID-19 infection, disease development, or reinfection. This study aims to help clarify the role of serology and other immune response tests in the diagnosis of COVID-19 in the pediatric population. Specifically, it aims to assess: the prevalence of SARS-CoV-2 seroconversion cases among the pediatric population accessing the National Health System (NHS), at different moments in time and in different regions of Italy; whether cellular immunity tests can help to identify children who have had SARS-CoV-2 infection, particularly children with low antibody levels, and thus to better estimate the prevalence of prior SARS-CoV-2 infection; the prevalence of cross-reactivity with other coronaviruses; whether immunity (antibody and cellular) is protective in the medium/long term; and if there are healthy carriers, i.e. individuals who have had prior SARS-CoV-2 infection, who are asymptomatic but may harbor SARS-CoV-2 in the pharynx, with the risk of transmitting it.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-17 years
* Access to National Health System facilities for blood collection.

Exclusion Criteria:

* Immunodepression (primary or secondary)
* Refusal to participate in the study
Can Combination of Low-Level Laser and Light-Emitting Diodes Enhance Stability of Dental Implants?

Subjects were assigned in two groups: In group 1, subjects received LLL and LED 20 min/day for 10 days after implant insertion, subjects in group 2did not undergo LLL and LED. implant stability quotients(ISQs) were measured in 0,10,21,42 and 63 days after implant placement.

Subjects eligible for study inclusion had an edentulous area at the first molar of the mandible and needed a dental implant. Subjects were excluded from study enrollment if they had any diseases that affect bone, smoking, insufficient bone in the edentulous area which needs bone augmentation, failed to return for follow-up, or refused study enrollment.

All implants were placed at least 3 months after tooth removal. The size of implants was 4.8X 10 mm (Zimmer, USA) Subjects were aligned based on computer randomization in two groups: In group 1(intervention), subjects received LLL and LED after implant placement and in group 2 (control) the same device was used while device was off.

A portable device was applied for irradiation of the intervention group with combination of 810nm laser and 632nm LED.

Subjects in group 1 underwent LLL 15 mw/cm2 and LED 10 mw/cm2 20 min every day for 10 days.

The mesiodistal and buccolingual directions were measured and the mean implant stability quotients (ISQs) were determined. The RFA measurements were performed in immediate after insertion (time0) 10 days (time1), 3 weeks (time2), 6 weeks(time3) and 9(time 4) weeks after implant placement.

Eligibility Criteria:
Inclusion Criteria:

* subjects eligible for study inclusion had an edentulous area at the first molar of the mandible and needed a dental implant

Exclusion Criteria:

* . Subjects were excluded from study enrollment if they had any diseases that affect bone, smoking, insufficient bone in the edentulous area which needs bone augmentation, failed to return for follow-up, or refused study enrollment.
Care Transitions Innovation (C-TraIn)

The purpose of this protocol is to evaluate the Care Transitons Innovation, a quality improvement project being implemented at OHSU to improve the transition from hospital to home for uninsured and Medicaid patients admitted to general medicine and cardiology wards at OHSU. The evaluation includes a baseline in-person survey and a 30 day post-discharge phone follow-up survey. Prior to C-TraIn, the local healthcare delivery model lacked an effective way to assure timely, safe, and effective follow-up care for uninsured and underinsured hospitalized patients. Most uninsured patients have no source for primary care, and many have limited social support, complex medical problems, and are prescribed many medications. Patients are frequently discharged without any coordinated plan for follow up. Based on a needs assessment performed in 2009 (OHSU eIRB 5514) investigators developed a quality improvement program that will include three major components: 1) a care transitions RN advocate who will see patients in the hospital and after discharge, 2) a pharmacy consultation and 30 days of medications post-discharge, 3) linkages with primary care medical homes, including payment for primary care for uninsured patients who lack a usual source of care, and 4) monthly meetings that serve as a platform for continuous quality improvement. In order to measure the success of our program, investigators will track patient utilization, sociodemographic factors, and patient factors including satisfaction, activation, and self-reported health status. To be included patients must be uninsured, have Oregon Medicaid, or be low income (200% or less of federal poverty level) Medicare recipients, and live within Multnomah, Washington and Clackamas Counties in Oregon.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized on one of seven inpatient treatment teams
* uninsured or low-income publicly insured (Medicaid; Medicare/Medicaid; or Medicare without supplemental insurance and ≤200% poverty level)
* reside in one of three metro-area counties (Multnomah, Washington, Clackamas)

Exclusion Criteria:

* not community dwelling (ie not from a long-term care facility or with plans to discharge to skilled nursing facility)
* no access to a working telephone (participants could list a friend or shelter phone)
* non-English speakding
* HIV positive (HIV+ patients were eligible for overlapping transitional care resources)
* disabling mental illness (as characterized by active psychosis or active suicidal ideation) or severe cognitive deficits
* plans to enter hospice.
Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System

Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System

The objective of this study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.

Eligibility Criteria:
Inclusion Criteria:

* Ages 2 or older
* Diagnosis of Type 1 diabetes or Type 2 diabetes
* Willing to wear the required number of Systems for the total duration of study wear
* Willing to participate in Clinic Session(s) during study wear

Exclusion Criteria:

* Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
* Known allergy to medical-grade adhesives
* Pregnancy
* Hematocrit outside specification
* ≥ 18 years of age:

  * Male: 36.0%;
  * Female: 33.0%;
* 13-17 years of age: 35.0%;
* 7 years - 12 years of age: 32.0%;
* End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
* Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period
Learning Small Bowel Capsule Endoscopy

This project is a prospective study investigating the education of medical doctors in gastroenterology with no prior experience to evaluate small bowel capsule endoscopies with a diagnostic sensitivity \>90%


Eligibility Criteria:
Inclusion Criteria:

* Medical Doctors in medical gastroenterology or surgery

Exclusion Criteria:

* Prior experience with evaluation of small bowel capsule endoscopy.
Observational Study to Observe the Safety of NovoMix® 30 Treatment in Patients With Type 2 Diabetes

This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.


Eligibility Criteria:
Inclusion Criteria:

* Any patient with diabetes type 2 diabetes
* Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin
* Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products
* Pregnancy, breast-feeding or intention of becoming pregnant within the next 6 months
A Precision Medicine Approach to Target Engagement for Emotion Regulation

The proposed study is designed to first test whether teaching people personalized or standardized emotion regulation skills leads to greater decreases in daily negative emotion intensity. Second, using data from an initial sample, the investigators will prospectively assign an independent sample of participants to receive their predicted optimal or non-optimal skills to determine if it is feasible and efficacious to match participants to the most appropriate training condition. Results of these studies may identify the mechanisms by which emotion regulation interventions impact emotional functioning and allow for the development of personalized, evidence-based, and scalable emotion regulation interventions.


Eligibility Criteria:
Inclusion Criteria:

* Elevated emotion dysregulation

Exclusion Criteria:

* Lack of proficiency in English
* No access to smartphone
* Conditions requiring greater than outpatient care