cyrilzakka/clinical-trials huggingface dataset:
Proleukin in Combination With Rituxan in Patients With Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments

The purpose of this study is to determine the safety and effectiveness of combination therapy with Proleukin and Rituxan on patients with low-grade Non-Hodgkin's Lymphoma who have previously failed Rituxan treatments.


Eligibility Criteria:
Diagnosis and disease status:

* Subjects with CD20+, B-cell, Non-Hodgkin's lymphoma of low-grade or follicular histology with measurable relapsed or unresponsive disease after prior therapy; mantle cell and chronic lymphocytic leukemia subtypes are excluded.
* Subjects who previously received a single-agent course of rituximab and showed no tumor response, or had a response lasting \< 6 months. The previously administered rituximab must have included at least 75% of the standard 4-week regimen (4 x 375 mg/m2). A record of the previous rituximab treatment and response must be available as a source document at the site.

Exclusion:

* Subjects who showed no tumor response or a response lasting \<6 months to treatment with Rituximab in combination with Chemotherapy or another therapeutic modality (radiation or radioimmunoconjugates).
* HIV positive.
* Symptomatic thyroid disease requiring medical intervention other than replacement treatment for hypothyroidism.
* Clinically significant cardiac, pulmonary, and /or hepatic dysfunction (if subject has history of congestive heart failure or myocardial infarction, must have been stable for at least 6 months, and have no current symptoms
* If cardiac ejection fraction has been measured, it must be greater than 50%.
Hepatitis B Vaccine Predialysis/Dialysis Study (V232-060)

To describe the immunogenicity and safety of modified process hepatitis B vaccine administered to renal predialysis and dialysis patients


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects at least 18 years of age
* Laboratory confirmed negative serology result to HbsAg (hepatitis b virus), anti-HBs (antibody to hepatitis B surface antigen), and anti HBc (antibody to hepatitis B core antigen) within 6 weeks of the initial dose of study vaccine
* Patient on renal dialysis or a pre-dialysis patient with a creatinine clearance of \<=30 ml/min

Exclusion Criteria:

* Previous hepatitis B infection, vaccination with any hepatitis B vaccine
* Recent febrile illness; hypersensitivity to any component of licensed hepatitis B vaccines
* Recent administration of immune globulin, licensed inactivated vaccine within 14 days or licensed live vaccine within 30 days prior to receipt of first study vaccine
* Receipt of investigational drugs or investigational vaccines within 3 months prior
* Impairment of immunologic function
* Recent use of systemic immunomodulatory medications
* Pregnant women, nursing mothers or women planning to become pregnant
Fenugreek: an Emergent Allergen

Fenugreek or Trigonella foenum greacum is an ancient medicinal plant native to the eastern Mediterranean, later spread to Asia (especially in India); it belongs to Rosaceae order, Leguminosae family, subfamily of Papilonaceae and it is used as a medicinal herb, spice or food. It is a component of spice mix, such as curry, and it is also used as a supplement in wheat and corn flour for bread-making. Fenugreek appears to have many health benefits and potential medicinal properties (antioxidant, antidiabetic, hepatoprotective, hypocholesterolemic, antimicrobial, anti-inflammatory, neuroprotective, anticarcinogenic, antiulcer, and antilithigenic) both in vitro and in vivo studies; for this reason it may be increasingly being used as nutraceutical formulations (powder, herbal teas, tablets and various combinations).This study aims to describe patients who came to our operating unit for suspected adverse reaction after ingestion of fenugreek and to highlight possible cross-reactivity between fenugreek and other legumes or other foods. Given the increasing use of novel spices in Mediterranean cuisine and the possible spread of fenugreek-based nutraceuticals, it is relevant to draw attention to possible allergic reactions.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 yo
* history of allergic reactions to spices
* history of allergic reactions to phytotherapics containing fenugreek

Exclusion Criteria:

* age \< 18 yo
* non suggestive history of allergic reactions to spices
Effect of CPP-ACP Paste on Dental Caries in Primary Teeth

The purpose of this study is to determine if adding daily application of CPP-ACP containing paste for one year is superior to regular fluoride tooth brushing in preventing dental caries in high caries risk Thai preschool children.

The 6th National Oral Health Survey in Thailand 2006-2007 reported that 3-year-old children who resided in central part have the highest dental caries prevalence of 69.8 percent with dmft affecting 3.63 teeth on average. Fluoride is widely accepted as the most effective tool to caries prevention for initial caries lesions. Current best practice recommends twice-daily tooth brushing with fluoride toothpaste for dentate children.

CPP-ACP can bolster the effects of fluoridated toothpaste alone to prevent caries.Currently, almost all clinical trials have investigated the effectiveness of CPP-ACP containing products in dental caries prevention and enhancing remineralization of initial carious lesion in the permanent dentition of young adolescents. There are no clinical studies of the effect of a CPP-ACP containing product to prevent dental caries in the primary dentition of young children.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Thai boys and girl aged between 2 1/2 - 3 1/2
* Normal development of dentition
* Diagnosed as high caries risk by using the Caries-risk Assessment Tool(CAT)

Exclusion Criteria:

* Chronic use of medications or antibiotics.
* Lack of cooperation in oral examination
* Milk protein allergy and/or benzoate preservatives
* Presence at baseline oral soft tissue lesion and enamel hypoplasia.
* Receive fluoride supplement and professional topical fluoride application at least three months before the beginning of study or during study period
rTMS for Depression

This is a longitudinal observational study, where we will track outcomes in patients undergoing 5 weeks of FDA approved right DLPFC rTMS treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects 18 to 80 years of age
2. DSM V diagnosis of a major depressive episode Subjects must have an initial score of at least 20 on the HAMD at screen
3. rTMS is clinically indicated
4. Patient is competent to provide informed consent

Exclusion Criteria:

1. Lifetime DSM-V diagnosis of schizophrenia, schizoaffective disorder, psychotic depression or any other psychotic disorder as defined in the DSM-V
2. Current (within the last year) diagnosis of anxiety disorder, obsessive- compulsive disorder, or eating disorder that precedes the onset of the current episode of depression and is the primary diagnosis
3. Current diagnosis of delirium, dementia, or amnestic amnesiac disorder
4. Diagnosis of mental retardation
5. Baseline Mini Mental State Exam (MMSE) score \< 21 or a total score falling two standard deviations below the age- and education-adjusted mean, whichever is less
6. Any active general medical condition or CNS disease which can affect cognition or response to treatment
7. Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week as indicated by self-report.
8. ECT or rTMS within three months
9. Pregnancy as indicated by self-report
10. MRI contraindications
11. Implanted electronic device or metal implant in the head and neck region (DBS, cochlear implant, etc)
12. Change in the dose of psychotropic medications within the past week

Inclusion Criteria for healthy volunteers:

1. Male or female between age 18 and 80
2. Patient is competent to provide informed consent

Exclusion Criteria for healthy volunteers:

1. Lifetime history of major chronic mental illness, such as schizophrenia, major depression, or bipolar disorder
2. Lifetime history of psychiatric hospitalization because of any mental illness Mental illness, other than depression, that needed psychological or pharmacological treatment in the past
3. Any neurodevelopmental or neurodegenerative disease, or stroke or positive findings on past head CT or brain MRI
4. Pregnancy
5. Hamilton Rating Scale for Depression (HRSD-17) is more than 7
6. MRI contraindications
Evaluation of Patient Functionality and Utility of Web-Based Personal Health History and Risk Assess

The purpose of this research study is to find out what Moffitt and Lifetime patients think of the electronic medical records process.

Patient will complete a questionnaire about their knowledge of computers and how long they think it will take them to finish the patient health history using a computer.

Patient will complete the electronic record carefully and tell us if they had any difficulties, questions or comments about the format.

Patient will answer a questionnaire about how well they liked or did not like using the electronic system to give their health history.

Participation in this study will take approximately 30 minutes to 1 hour.

Eligibility Criteria:
Inclusion Criteria:

* The breakdown of patients recruited by stratified dimensional sampling. Overall, we will attempt to equally recruit patients from the unique strata for each domain evaluation in this study. Patients health status will be determined by the ECOG Performance status . We assume that all patients being seen at the Lifetime Cancer Screening and Prevention center will be of good to fair health, while patients seen at the Cancer hospital will range from good- to- fair to poor health status. Gender is also used as a sampling factor because there are modules within this web-based health history forms that are specific for each gender.

Exclusion Criteria:

* Respondents who refuse to participate or who become too ill at any point in the assessment, will be excluded. Non-English speaking patients will be excluded. Names and other identifying information will not be collected and all data will be reported in aggregate form. Due to the nature of our stratified samples strategy, some patients will be excluded if they meet the criteria for a recruitment stata, but that stata is full.
Pain Therapy After Elective Cardiac Surgery

The purpose of this study is to determine generation of a target controlled infusion model for the patient controlled analgesia with the strong analgesic, hydromorphone, after planned open heart surgery, during which the strong analgesic, sufentanil, was used.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent,
* Ability to understand the nature of patient-controlled analgesia and other study-specific procedures,
* Elective cardiac surgery with thoracotomy and subsequent stay in the intensive care unit

Exclusion Criteria:

* Use of MAO inhibitors in the last 14 days,
* Chronic alcoholism or drug addiction in medical history,
* Severe obstructive or restrictive pulmonal disorders in medical history,
* Severe hepatic and renal disorders in medical history,
* Hypothyroidism, pancreatitis in medical history,
* ASA IV,
* Pregnant or nursing females
Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis

An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.


Eligibility Criteria:
Inclusion Criteria:

* Must have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR,
* Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not participate in any part of C99-717, including interim visits, must have prior sponsor approval before admission into C-728

Exclusion Criteria:

* Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. Female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study
* Clinically significant abnormal hematology values or history of an immunosuppressive disorder
* Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
* A significant change in the subject's medical history from their previous alefacept study
* Any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study C99-712 or C99-717
* Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed)
Comparison of Conservative Treatment and Graston and Cup Applications in Patients With Cervical Disc Herniation

The aim of the study is to examine the effects of graston and dry cupping techniques applied in addition to the conservative treatment program on neck awareness, grip strength, balance and sleep quality in patients with cervical disc herniation between the ages of 18-65.

The research will be carried out on 30 cases diagnosed with cervical disc herniation between the ages of 18-65. The patients will be divided into 2 groups as control and experimental groups by simple randomization method. While the conservative physical therapy program is applied to the control group, the patients in the experimental group will be applied 1 day graston and 1 day dry cup technique in addition to the ones in the experimental group. All patients will be treated for 20 sessions, 5 days / 4 weeks. Fremantle Neck Awareness Questionnaire to assess neck awareness, hand dynamometer to assess grip strength, Berg Balance Scale to assess balance and Jenkins Sleep Scale to assess sleep quality will be used. All tests will be measured at the start of treatment and after 4 weeks of intervention. Pre- and post-intervention data were statistically analyzed and compared.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65
* Being diagnosed with cervical disc herniation
* Being diagnosed with cervical disc herniation at the level of bulging or protrusion according to MRI results

Exclusion Criteria:

* Presence of cervical spine surgery history
* Presence of primary or spinal metastatic malignancy
* Having vascular problems
* Individuals with sleep apnea
* Those who use psychiatric drugs
* Presence of various pathologies in the upper extremity (fracture, ganglion cyst, etc.)
OXN PR vs Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome (BPS)

The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects suffering from severe pain due to Bladder Pain Syndrome.

The study consists of a screening period followed by randomisation of the patients in a 1:1 ratio to OXN PR treatment or placebo treatment in a double blind fashion. The double blind phase will last for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* History of severe pain due to Bladder Pain Syndrome (BPS) for at least 6 months
* Subject's treatment of pain due to BPS is insufficient
* Subjects must not have received opioid containing medication in the last 6 months

Exclusion Criteria:

* Females who are pregnant or lactating
* Subjects with any contraindication/history of hypersensitivity to oxycodone, naloxone, paracetamol, related products or other ingredients
* Subjects with any situation in which opioids are contraindicated like severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma or paralytic ileus
* Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results
* Abnormal aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatise levels (\> 3 times the upper limit of normal), gamma glutamyl transpeptidase \> 3 times the upper limit of normal
* Abnormal total bilirubin and/or creatinine level(s)
Interaction Between Chlorhexidine and Fluoride

The aim of the present study was to study if there are interactions and reduced clinical effect between chlorhexidine and fluoride when they are combined in the same mouthrinse.

The investigation assessed the clinical effect of a mouthrinse containing chlorhexidine (CHX) and sodium fluoride (NaF) during a 4-day period of non-brushing and a 6-week period of brushing. Two studies were designed as double-blind, randomized, cross-over clinical trials. In study I, 16 healthy subjects rinsed twice daily for 1 min during 4 days of no tooth brushing with four mouthrinse solutions: 1) 0.12% CHX + 0.2% NaF, 2) 0.2% NaF, 3) 0.12% CHX, and 4) placebo. In study 2, 16 healthy subjects rinsed with the same four solutions twice daily after tooth brushing during a 6-week period. Primary outcomes were plaque formation and gingivitis. Secondary outcomes were fluoride retention and microbiological parameters in plaque and saliva (total bacterial counts and mutans streptococci, lactobacilli and streptococci sanguinis counts). One way analyses of variance with post hoc Student-Newman-Keul´s statistical test was performed for comparisons between mouthrinses. Intragroup changes over time were analyzed with a paired t-test.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects, age 18-35 years
* Good general health
* No signs of periodontitis and caries
* A minimum of 24 teeth with no extensive restorations
* No current or planned dental treatment during the trial periods.

Exclusion Criteria:

* Antibiotic treatment within 1 month prior to the start of the trial
* Current medication with anti-inflammatory drugs
* Use of antiseptic mouthrinses
* Smokers and snuff user
* Use of chewing gums
Costs of the Patient's Stay Under ExtraCorporeal Membrane Oxygenation From the Hospital Point of View: a Pilot Study at the Rennes University Hospital Center

The objective of this study is to determine the average cost of stay of a patient supported by ExtraCorporeal Membrane Oxygenation from the point of view of the hospital facility, during the hospitalization in which the ECMO was implanted.


Eligibility Criteria:
Inclusion Criteria:

All patients ≥18 years old who have benefited from an ECMO (no type, no indication) between 2004 and 2016 at the Rennes University Hospital, identified in the database of the Rennes University Hospital Center will be included in this study.

Exclusion Criteria:

Neither
Relaxin, Matrix Metalloproteinase-2 and Interleukin-6 in Women With Chronic Pelvic Pain

In our study, by evaluating the serum and vaginal-peritoneal fluid levels of Relaxin, Matrix Metalloproteinase-2 and Interleukin-6 in women over 35 years of age with chronic pelvic pain, the investigators aimed to reveal their potential to be an important marker in the diagnosis of Deep Infiltrative Endometriosis, thus enabling early diagnosis with lower cost and results that can be obtained in a short time.The investigators aim to reveal its relationship with follow-up.

In our study, the values of Relaxin, MMP-2 or IL-6 from vaginal fluids were found to be significantly higher than the control group in the prediction and follow-up of deep infiltrative endometriosis. This supports the role of Relaxin and MMP-2 as well as IL-6 in the pathophysiology of deep infiltrative endometriosis.

Histologically based and multicenter randomized controlled studies with more patients are needed to elucidate the etiology and pathophysiology of endometriosis.

10 cc of vaginal washing fluid, serum samples on the day of operation and 20 cc of pelvic washing fluid during laparoscopy were taken from all patients before the operation. Patients were included in the FA group according to the ENZIAN Classification. Patients' age, BMI, gravida, parity, obstetric history such as pregnancy, ethnic origin, educational status, preoperative and postoperative evaluation for chronic pelvic pain, laboratory tests (routine tests such as Ca125, CRP, FSH, LH, E2, P), Preoperative and postoperative hormonal values were recorded. Relaxin, MMP-2 and IL-6 values from vaginal washing fluid, peritoneal washing fluid and serum samples of the patients in the control and study groups were compared.

Eligibility Criteria:
Inclusion Criteria:

Endometriosis patients Adenomyosis patients

Exclusion Criteria:

Ovarian endometriosis Chronic pelvic pain with another reason
Testing an Herbal Pain Relief Patch to Reduce Pain in Cancer Survivors

The purpose of this study is to find out whether Tibetree Pain Relieving Plaster, an herbal pain relief patch, may be able to reduce this pain. Tibetree Pain Relieving Plaster is available as an over-the-counter (non-prescription) treatment for the temporary relief of minor aches and pains in muscles and joints. This study is the first to test this treatment in people who have had cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years or older
* A diagnosis of cancer with no restrictions placed on type of cancer or stage. Eligibility criteria will not be restricted to MSK confirmed biopsy/diagnosis. Participating institution's testing is sufficient for other study sites
* Completed active treatment (surgery, chemotherapy, and/or radiotherapy) at least one month prior to study initiation (patients on continued hormone treatment or maintenance targeted therapies will not be excluded).
* Patients currently have no evidence of disease
* Ambulatory (Karnofsky functional score of ≥ 60)
* Having a focused location of regional musculoskeletal pain (e.g. joints, extremities, back, neck) that can be covered by one patch of PRP
* Worst pain score (numeric pain rating scale) 5 or above in the preceding week
* Pain for at least 3 months and at least 15 days with pain in the preceding 30 days; and willingness to adhere to and understanding of all study-related procedures, including randomization to one of the two possible choices
* Able to understand informed consent and provide signed informed consent form

Exclusion Criteria:

* Patients with non-musculoskeletal pain syndromes (headache, facial pain, chest pain, visceral abdominal pain) will be excluded if these are the sole source of pain but can be present as co-morbid conditions as long as a patient has a primary musculoskeletal pain condition defined as above.
* Patients have generalized musculoskeletal pain such as fibromyalgia
* Use of corticosteroid drugs by any route of administration within 30 days
* Patients with significant self-reported skin disorders
* Patients with open wounds, infections, skin trauma at skin overlying area of pain
* Patients with documented history of skin sensitivity to adhesive or allergic reaction to other patches or topical analgesics
* Patients with documented skin allergic reaction to plants or herbs
* Patients who are in active treatment (chemotherapy, surgery, radiotherapy)
* Plan to change or initiate other pain medications or interventions (e.g. physical therapy, acupuncture, injection). Patients may remain on their current pain regimen.