cyrilzakka/clinical-trials huggingface dataset:
Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes

This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in subjects with insulin requiring diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Duration of diabetes mellitus for at least 2 years
* Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
* HbA1C below 11.0%

Exclusion Criteria:

* Impaired renal function
* Impaired hepatic function
* Serious heart diseases
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia
* Proliferative retinopathy or maculopathy requiring acute treatment
* Uncontrolled treated/untreated hypertension
* Current treatment with total insulin dose of more than 100 IU/day
* Current treatment or expected at the screening to start treatment with systemic corticosteroids
Treatment Response to Xiaflex for Men With Peyronie's Disease

The purpose of this research study is to develop a database of patients with Peyronie's disease who are treated at the University of Miami. The collected data will help the researchers to better understand Peyronie's disease and its response to therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Able to provide informed consent
* A stable relationship for ≥3 months
* PD symptoms with evidence of stable disease as determined by the investigator
* Penile curvature deformity of \>30° to \<90°
* Has not had previous surgery for PD
* Has not had previous therapy with Xiaflex for PD

Exclusion Criteria:

* Ventral plaque
* Active phase PD
* Actively on anticoagulation during time frame of injections
* Aspirin 81mg will be eligible for therapy
* Hour glass deformity
* Previous allergic reaction to Xiaflex
* Unwilling to participate
* Medically unfit for sexual intercourse as deemed by the principal investigator
* Patients scheduled to undergo an elective medical procedure during the investigation timeframe that will interfere with Xiaflex injection cycles as deemed by the PI
Traumeel for Post-Tonsillectomy Pain

Tonsillectomy is one the most common procedures in ear, nose and throat (ENT) medicine. Following surgery patients suffer from severe pain and difficulty on swallowing, while analgesic treatment has limited efficacy and potential adverse effects such as increased bleeding with NSAIDs. Traumeel S is a homeopathic complex remedy used primarily in Europe for the treatment of pain and inflammation. It contains a number of plants and minerals at high dilutions (between 1x10-2 to 1x10-8), and has been shown to exhibit anti-inflammatory properties such as cytokine inhibition in human T cells, monocytes and gut epithelial cells. Clinical studies have found Traumeel S reduces post-chemotherapy stomatitis, as well as post-surgical inflammation and pain following orthopedic procedures.

The purpose of this study is to examine the effect of Traumeel S on post-tonsillectomy pain in adult patients. The study group will consist of 20 patients age 18 years of age and older following elective tonsillectomy. These patients will be randomly assigned to receive treatment with either true Traumeel S remedies or placebo. One ampule of Traumeel S (or placebo) will be sprayed over the resected area immediately following surgery. Two Traumeel S (or placebo) tablets will be taken subsequently 4 times daily (Total: 8 tablets per day)until no analgesics are required for 2 consecutive days, or until Day 14 (whichever comes first). Patients will be allowed to take dipyrone (Optalgin) 500mg tablets on an as-needed basis, for up to 14 days postoperatively. At the end of this period, a thorough ENT examination will be done.

The primary parameter to be evaluated in the study will be postoperative pain, as registered on a numerical pain rating scale (NRS), to be filled prior to surgery. In the post-anesthesia care unit (PACA) the NRS will be filled out again, this time for pain at rest and then again for pain upon swallowing - at 1, 2, 3,4 and 24 hours postoperatively. Secondary parameters to be evaluated are: analgesic use (dipyrone); post-operative bleeding (quantified on a scale of 1-4); nocturnal awakenings; time to resumption of eating and return to normal activity; cytokine levels (CRP, IL-6) at 36 hours postoperative; and side effects of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Recurrent tonsillitis or obstructive tonsillar hypertrophy requiring tonsillectomy.

Exclusion Criteria:

* Elective or emergency tonsillectomy for a reason other than those listed above.
* History of peritonsillar abscess, or need for additional ENT procedures (adenoidectomy, uvulectomy)
* Pregnancy, breastfeeding
* Asthma, Epilepsy
* Concurrent illness with impairment of wound-healing (diabetes, vascular disease)
* allergy or contraindication to use of protocol medication (dipyrone)
* inability to comply with the protocol conditions.
Nociceptors, Neurotrophic Factors and Cytokine Expression in Gastroesophageal Reflux Disease

Transient receptor potential vanilloid-1 (TRPV1) receptor and proteinase-activated receptor 2 (PAR2) have been implicated in the mechanism of acid induced inflammation in gastroesophageal reflux disease (GERD). We aimed to evaluate TRPV1 and PAR2 mRNA expression levels in the GERD patients and their relationship with endoscopic findings and reflux symptoms.

All the subjects receive upper GI endoscopy and completed questionnaires about GERD symptoms under the supervision of a well-trained interviewer. Subjects are excluded if there was a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and if he or she had any history of systemic disease requiring chronic medication (except for hypertension and diabetes mellitus).

The subjects are classified into 3 groups after upper GI endoscopy and completing questionnaires about GERDsymptoms ; ERD(erosive reflux disease), NERD(nonerosive reflux disease) and control group.

Eligibility Criteria:
Inclusion Criteria:

* subjects who completed upper GI endoscopy and questionnaires about GERD symptoms

Exclusion Criteria:

* a history of gastrointestinal surgery
* Barrett's esophagus
* esophageal motility disorder
* duodenal ulcer
* benign gastric ulcer
* gastroduodenal cancer
* if he or she had any history of systemic disease requiring chronic medication (except for hypertension and diabetes mellitus).
Improving Health and Wellness for People with Serious Mental Illness in Puerto Rico

This study evaluates the effectiveness of a culturally tailored intervention, Bridges to Better Health and Wellness (BRIDGES), aimed at reducing chronic disease disparities among Puerto Ricans with serious mental illness (SMI). Participants receive monthly sessions with health care managers to address patient-provider stigma and care coordination.

BRIDGES is a multi-level Healthcare Manager Intervention (HMI) that addresses both patient and provider barriers to healthcare. It includes culturally adapted modules to reduce stigma and promote chronic disease prevention. The study uses a hybrid type 1 effectiveness-implementation randomised controlled trial to test its impact on primary care service use, chronic disease outcomes and stigma reduction over 12 months.

Eligibility Criteria:
Inclusion criteria:

Adults receiving psychiatric or psychological services at the Wellness Center or the Mayaguez Medical Center - Primary Care Diagnosed with at least one serious mental illness SMI (e.g., schizophrenia, bipolar disorder, major depression, etc.) Have at least one risk factor or a diagnosis of a chronic health condition (e.g., diabetes, overweight, hypertension, etc.).

Be willing to receive or continue preventive medical care with a primary care physician.

Exclusion criteria:

Have started psychiatric or mental health services at least one month before Have been diagnosed with a general mental health condition (e.g., Depression or Anxiety).
Knowledge and Perception of Smoking Risks/Consequences

This proposed 2-year questionnaire study examines views and attitudes regarding health risks of cigarette smoking, smoking patterns and motivators for cessation in smokers who suffer from schizophrenia compared to a sample of smokers without a major psychotic disorder.

This proposed 2-year questionnaire study examines views and attitudes regarding health risks of cigarette smoking, smoking patterns and motivators for cessation in smokers who suffer from schizophrenia compared to a sample of smokers without a major psychotic disorder. The specific goals of this study are to 1) examine differences in the perceived consequences of smoking, smoking habits, and motivation to quit between adults with and without schizophrenia and 2) identify clinical and demographic variables (e.g., age, race, sex, age of smoking onset, knowledge of smoking consequences, insurance status, family support, co-occurring substance abuse, education level, current health status) associated with motivation to quit smoking among individuals with and without schizophrenia. This secondary goal is exploratory in nature. We will identify potential predictors in each group separately and also assess if these potential predictors differ between groups.

The study will consist of one 2-hour visit, where each subject, after signing consent, will participate in a semi-structured interview as well as answer clinical and demographic information. Patient volunteers will be recruited from the MPRC Outpatient and Inpatient Programs and through NIDA. Control subjects will be recruited by MPRC and NIDA via newspaper advertisements from the Baltimore metropolitan area. We anticipate recruiting up to 110 schizophrenia patients for a total of 100 completers and up to 110 normal controls for a total of 100 completers. All participants will be 18-65 years old, will smoke cigarettes daily, and must not be interested in reducing or quitting tobacco use.

Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18-65 years
* Minimum of 5 cigarettes daily.
* Expired CO measurement of \> 8 ppm to confirm cigarette smoking
* For the schizophrenia group, must have a DSM-IV diagnosis of schizophrenia or schizoaffective disorder.

Exclusion Criteria:

* For the normal control group, must be free from Axis I psychotic disorder. (other psychiatric comorbidity will not be excluded)
* For all subjects, anyone actively trying to quit smoking at the time of the interview.
Study of Nucel for One and Two Level Lumbar Interbody Fusion

The study is a prospective non-randomized multi-center feasibility clinical trial to establish the safety and efficacy of the Nucel® allograft tissue for use in lumbar interbody fusion procedures.

Two hundred non-randomized subjects will participate in the study at up to ten clinical sites in the United States. Participants will be between 18 and 75 years of age. All subjects will have been established with lumbar spine disease at one or two levels of the lumbar spine that requires lumbar interbody fusion procedure as per the opinion of the treating surgeon. The diseases included in the study are spondylosis, degenerative disc disease and spondylolisthesis. All subjects who meet the inclusion criteria and do not meet the exclusion criteria and who elect to participate and sign the informed consent will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Be between 18 and 75 years of age
2. Have clinical and/or radiological evidence of stenosis, spondylolisthesis, spondylosis or degenerative disc disease, or at either one or two levels of lumbar spine.
3. In the opinion of the treating surgeon, must already be a qualified candidate for interbody lumbar fusion surgery with supplemental fixation.
4. Be likely to return for regular follow-ups until the end of the study period.
5. Be willing and able to provide Informed Consent for study participation.

Exclusion Criteria:

1. Previous lumbar spine fusion surgery at operative level.
2. Back pain due to acute trauma.
3. Clinical, laboratory and/or radiological evidence of back pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.)
4. No chronic steroid or chronic prescription NSAID use within three (3) months prior to surgery.
5. Any active malignancy, infectious process, or documented chronic autoimmune disease.
6. Any other concurrent medical disease or treatment that might impair normal healing process.
7. Recent history (within past 6 months) of any chemical or alcohol dependence.
8. Morbid obesity (BMI \> 40).
9. Currently a prisoner.
10. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
11. Pregnancy at the time of enrollment or planned pregnancy, which would interfere with follow-up imaging.
Evaluating Patient and Physician Cost Knowledge in the Emergency Department

The purpose of this study is to identify existing cost knowledge of Emergency Medicine (EM) physicians and patients and investigates its reported impacts on medical compliance. A cross-sectional survey will be administered electronically to Emergency Medicine physicians at the University of Utah Hospital and the Emergency Physician Integrated Care, LLC (EPIC) who staff ten-community hospital Emergency Departments (ED) in order to investigate physician knowledge and attitudes regarding cost and perceived patient compliance. In addition, a cross-sectional survey will be administered to a convenience sample of patients presenting to the University of Utah Emergency Department to obtain information about their cost knowledge and reported compliance. All ED patients will complete a follow-up phone survey to measure compliance with recommendations made during the ED visits. Following administration of the baseline survey physicians will be provided the prices of the test and procedures and will be re-surveyed 30-days later as a post intervention test to measure changes in knowledge and attitudes.


Eligibility Criteria:
Inclusion Criteria Patient Population:

* 18 years old or older
* Deemed psychologically and medically stable by the ED care provide
* Speak English

Exclusion Criteria Patient Population:

* Prisoner
* Brought to Emergency Department by Emergency Medical Service

Inclusion Criteria Physician Population:

* Employed in target medical practices

Exclusion Criteria Physician Population:

* none
Burden of Disease in Myasthenia Gravis

Questionnaire-based survey addressed to german patients with the chronic autoimmune muscle disease called myasthenia gravis regarding quality of life, socioeconomic impact, social support, course of disease, complications of therapy and psychological comorbidities.

Background:

Myasthenia gravis is a rare, chronic, antibody-mediated autoimmune disease that results in muscular weakness. The patients suffer from symptoms such as visual disturbances (especially double vision), weakness in the arms and legs, chewing and swallowing disorders and respiratory disorders, as well as crisis-related worsening of ventilation. This is often accompanied by pronounced fatigue (physical) and mental fatigue (depression).

Despite drug therapies that are on one hand symptomatic improving muscle strength, and on the other hand modulating the immune system, as well as specific procedures and drugs used in crises (plasmapheresis, immunoglobins) or refractory patients, patients are often severely limited, affecting everyday activities of self-care, family, social and professional life, thus affecting the mood and quality of life of patients. There is a lack of data measuring quality of life adequately.

Aim:

The aim of the data collection is to record the quality of life of myasthenia patients. By clinical information on the disease (including symptoms, course and therapy) and recording the social and occupational situation, the data should be contextualized. The following hypotheses are to be confirmed:

Primary hypotheses

* Myasthenia gravis affects the quality of life of patients comparable to neurological diseases such as multiple sclerosis
* Patients are limited in their participation in their private and professional life
* The severity of the disease is associated with the quality of life. Secondary hypotheses
* Myasthenia is associated with income busses and other economic disadvantages of the night
* Quality of life in myasthenia patients is related to fatigue and depression
* Quality of life in myasthenia patients depends on different therapy methods
* Myasthenia gravis has an impact on family planning and care for children.

Methods:

In cooperation with the German Myasthenia Gravis Society, a questionnaire prepared by the Charité will be sent to its members with a request for completion and an anonymous return. Similar projects have already been implemented in the past (response rate\> 30%). About 3,300 patients should be contacted.

The returned questionnaires are then statistically evaluated and presented as part of a publication. For the evaluation of the hypotheses suitable descriptive, univariate analysis methods are used. Furthermore, with sufficient case numbers, multivariate analyzes (e.g., logistic regression) are also planned.

The questionnaire contains general information and questions about:

* Education and employment
* Social situation
* Social Support
* Economic aspects
* Symptoms and severity, course, treatment of myasthenia
* Quality of life
* Fatigue and depression

Eligibility Criteria:
Inclusion Criteria:

* Patients with Myasthenia Gravis
* Age ≥18 years

Exclusion Criteria:

* none
Lamivudine Plus Adefovir Versus Telbivudine Plus Adefovir in Lamivudine Resistant Chronic Hepatitis B

No study has reported on the comparative effect of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir in HBeAg-positive lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir. The goal of this study is to compare the efficacy of continuing lamivudine plus adefovir versus switching to telbivudine plus adefovir directly in patients with lamivudine-refractory chronic hepatitis B patients who have suboptimal response to lamivudine plus adefovir for at least 12 months.


Eligibility Criteria:
Inclusion Criteria:

* HBeAg positive
* lamivudine and adefovir at least 12 months over 6 months lamivudine treatment for YMDD positive patients
* HBV DNA over 300 copies/ml

Exclusion Criteria:

* decompensated cirrhosis
* renal failure
* prior interferon usage
* evidence of HCC or prior organ transplantation
Investigating the Relationship Between Physical Function, Comorbidity and Cytogenetic Risk Group in Older Adults With Acute Myelogenous Leukemia (AML)

AML is a disease of older adults, with a median age at diagnosis of 67 years . An estimated 13,410 new cases of AML will be diagnosed in 2007. Survival for AML is age-dependent, with significantly lower survival rates reported for older adults. SEER statistics from 1996-2003 show a 5 year relative survival rate of 34.4% for adults younger than 65 and 4.3% for those ≥65 years of age 1. Clinical trials have demonstrated worse survival outcomes in older adults with AML using age cutoffs of 55, 60 and 65 years. Older adults have also experienced increased toxicity to standard therapies in clinical trials. Chronologic age cutoffs have therefore been used in research and clinical practice due to concerns regarding toxicity associated with treatment. The reasons for the increased toxicity and decreased survival in older adults with AML is incompletely understood and likely multifactorial including both tumor specific and host specific factors. Improving understanding of which measurable clinical characteristics predict vulnerability to toxicity will help refine the research and clinical approach to older adults with AML.


Eligibility Criteria:
Inclusion Criteria:

* Capacity to provide signed protocol specific informed consent
* Age ≥ 60 years
* Pathologically confirmed newly diagnosed AML or undergoing workup for suspected AML
* Planned induction chemotherapy
* Inpatient status

Exclusion Criteria:

* Requiring intensive care unit support during initial evaluation
* Prior therapy for AML
* ECOG score \>3
Tolerance of an Oral Nutritional Supplement(ONS)

The objective of this study is to capture information on gastrointestinal tolerance (GI) of an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to ≤ 10 years.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 3 and ≤ 10 years of age
* Healthy and not suffering from any physical disability.
* Height-for-age and BMI-for-age between the 5th and the 95th percentile as well as a weight-for-age between the 5th and the 85th percentile
* Consumption of 2 servings/day of the investigational product for 7 consecutive days
* Willingness to follow the study procedures and record the data in the diary and complete any forms or assessment as needed throughout the study
* Agreement to not consume a nutritional product that is not study product during the study period

Exclusion Criteria:

* History of an acute or chronic condition that may affect feeding habits or nutritional status
* Medications or nutritional supplements, taken on a daily basis for more than 2 weeks during the past month prior to screening visit that may profoundly affect feeding habits or nutritional status
* Clinically significant nutritional deficiency requiring specific treatment
* Acute/chronic condition requiring medical treatment which may include hospitalization such as diabetes or stress induced hyperglycemia, dialysis treatment, inflammatory bowel disease, pancreatitis, autoimmune disease or immunodeficiency, celiac disease, cystic fibrosis, active tuberculosis, malformation of the gastrointestinal tract or gastroesophageal reflux disease
* History of constipation
* Allergy or intolerance to any ingredient in the study product
* Gastrointestinal infection or acute diarrhea at the time of study start
* Hepatitis B or C, or HIV, or malignancy
* Congenital cardiac defects
* Antibiotic therapy within last 2 weeks of start of study
* Dysphagia, aspiration risk, difficulty in swallowing due to acquired/congenital abnormalities
Combination Bisphosphonate and Anti-Angiogenesis Therapy With Pamidronate and Thalidomide

The purpose of this research is to study how helpful the combination of thalidomide and Pamidronate or thalidomide and Zometa is in controlling the myeloma disease and to study any side effects.

Recently laboratory research found that thalidomide can inhibit the formation of new blood vessels that are necessary for the growth and spread of cancer. In order to grow and increase in size tumors require new blood vessels to supply them with the necessary blood to grow. If we can prevent these new blood vessels feeding the tumor from being formed by using thalidomide we might slow or stop the growth of the tumor. This concept is called "anti-angiogenesis" It is hoped that thalidomide will slow or stop the growth myeloma. However, it cannot be guaranteed that you will benefit if you take part in this study. The treatment you receive may even be harmful.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of Smoldering or Indolent myeloma
* All patients must be informed of the investigational nature of this study and must sign a written informed consent in accordance with UAMS Human Research Advisory Committee and federal guidelines.

Exclusion Criteria:

* Prior bisphosphonate therapy within 30 days prior to study entry.
* Serum creatinine \> 5 mg/dl, ascites, or serum direct bilirubin \> 2.5 mg/dl.
* Prior plicamycin or calcitonin within 2 weeks of study entry.
* Severe cardiac disease, unstable thyroid disease, or epilepsy.
* Prior radiation therapy to \> 20% of the skeleton.