cyrilzakka/clinical-trials huggingface dataset:
Radiation Therapy in Treating Patients With Progressive or Recurrent Malignant Brain Tumors

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who are undergoing surgical removal of progressive or recurrent malignant brain tumors.

OBJECTIVES: I. Evaluate the safety of the GliaSite RTS in patients with progressive or recurrent malignant brain tumors undergoing surgical resection. II. Evaluate the performance of the GliaSite RTS in these patients.

OUTLINE: This is an open label, multicenter study. Patients undergo surgical resection of the tumor followed by surgical placement of the GliaSite device in the resection cavity. One to 2 weeks after surgery, patients receive brachytherapy consisting of an infusion of iodine I-125. The I-125 solution is removed and collected 5-7 days later. The device is surgically removed within 24 hours. Patients are followed at 24 hours, 14 days, and 1 year post device removal.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma: Anaplastic astrocytoma Anaplastic oligodendroglioma Glioblastoma multiforme Unifocal disease Progressive or recurrent disease following radiation therapy and/or chemotherapy Must be eligible for surgical resection of the tumor mass No unresectable leptomeningeal spread or ventricular invasion outside the radiation treatment volume No exophytic ventricular tumors Must have a maximal cross-sectional diameter enhancing tumor greater than 2.0 cm but not greater than 5.0 cm by preoperative MRI Ratio of major axes of the tumor should not exceed 1.5 No marked edema by preoperative MRI or CT that cannot be corrected by tumor resection

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No uncontrolled hypertension, angina pectoris, or uncontrolled cardiac dysrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No serious concurrent infection or other medical illness No prior or concurrent malignancy within 5 years except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: See Disease Characteristics No concurrent chemotherapy At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 months since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: At least 4 weeks since prior use of medical device No concurrent investigational agents
A Closer Look at the Effect of Dextrose on Postoperative Nausea and Vomiting

"The purpose of this investigator-initiated study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood surgery level. The reason for this study is that IV dextrose has been shown to decrease the incidence of PONV and the use of medications to treat PONV, while leading to sooner discharge after surgery. This can decrease overall healthcare cost and improving patient satisfaction."


Eligibility Criteria:
Inclusion Criteria:

1. ASA I or II
2. female urologic, gynecologic and breast surgery patients undergoing scheduled same day procedures at LLUMC Heart and Surgical Hospital

Exclusion Criteria:

1. age \<18 or \>65;
2. severe hypertension,diabetes mellitus, significant hepatic or renal disease
3. excessive blood loss
4. sustained (\>10 min)\>20% from baseline drop in BP after treatment
5. inability to follow protocol
6. refusal to sign consent
Effect of Acupuncture on Mild to Moderate Active Crohn's Disease

To observe the clinical effect of acupuncture on Crohn's disease (CD) and its influence on brain function activity and the TRY-KYN metabolism level, and to screen the brain image markers of acupuncture on CD

1. Effect of acupuncture on symptoms of CD
2. Effect of acupuncture on brain functional activity of CD
3. Effect of acupuncture on intestinal and plasma TRP-KYN metabolism level of CD
4. Screen the brain image markers of acupuncture in the treatment of CD

Eligibility Criteria:
Inclusion Criteria:

1. aged 16-70;
2. patients with mild or moderate active disease (150 ≤ CDAI \< 450);
3. patients who are not responsive, intolerant, dependent or refused to use at least mesalazine, glucocorticoid, immunomodulator (azathioprine, methotrexate), anti TNF alpha preparation;
4. patients were not taking medication or were only taking one or more of the following drugs: \[prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)\] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months;
5. those who did not use anti-TNF alpha and other agents within 3 months before entering the study;
6. those who have never experienced acupuncture;
7. patients signing informed consent.

Exclusion Criteria:

1. patients who are recently pregnant or in pregnancy or lactation;
2. patients with serious organic diseases;
3. patients diagnosed as psychosis;
4. patients who take antibiotics, probiotics, traditional Chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial;
5. severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations;
6. there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications;
7. patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year;
8. there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.
Effect of B.Bifidum 900791 Intake in Adult With Hypolactasia and Lactose Intolerance

Lactase is high in the newborn intestine, allowing him to digest the high amounts of lactose present in breastmilk. From weaning, lactase is genetically programmed to decrease, reaching residual levels in the adult. This situation occurs in 75% of the world population and is known as "adult primary hypolactasia" while the remaining 25% is "lactase persistent" i.e. maintains in adulthood lactase values similar to these of newborns. In subjects with hypolactasia, the intake of milk products can produce digestive symptoms, making that the affected individuals spontaneously reduce the consumption of these products and, therefore, their intake of calcium and proteins.

In addition to lactose-free milk and exogenous lactase, a strategy for the intolerant subjects to continue consuming dairy products is, for example, to consume yogurt, due to the fact that the lactase of the yogurt bacteria continues to function in the intestine of the consumer, hydrolyzing lactose and decreasing the development of digestive symptoms. Similarly, many probiotic strains, such as L. acidophilus NCFM, L. casei CRL431, B. longum 401 and B. bifidum Orla Jensen 1424, express β-galactosidases that hydrolyze lactose, preventing its fermentation and the production of gases. The acute administration of these strains improves lactose tolerance. In addition, a recent study reported that dietary supplementation of intolerant subjects for 4 weeks with L. casei Shirota and B. breve Yakult reduced digestive symptoms and breath hydrogen excretion not only at the end of the period of administration of the probiotics but also 3 months after having discontinued the use of probiotics.

Based on this background, the aim of this study is to determine whether the regular consumption of an ice cream with the strain B. bifidum 900791 improves lactose intolerance in hypolactasic subjects, even after the suspension of the consumption of the product. To determine if this effect is due to the adaptation of the microbiota, the investigators will also evaluate changes in the composition of the microbiota and the generation of volatile fatty acids.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hypolactasia and lactose intolerance

Exclusion Criteria:

* Diarrhea
* Previous gastrointestinal pathologies
* Current or recent intake of antibiotics, anti-inflammatory drugs, laxatives or drugs interfering with intestinal transit
* Alterations of intestinal anatomy or function
* Pregnancy
* Chronic diseases of different etiologies (auto-immune, inflammatory, tumor, etc.).
Pro-calcitonin for Early Detection of Septic Arthritis

Background:

Children presenting with non-traumatic joint pain require different treatment depending on the cause of pain. Septic arthritis, which results from a bacterial infection in the joint, often requires a surgical procedure as well as a long course of antibiotics. In contrast, non-septic arthritis is typically treated by management of symptoms and observation. Current diagnostic standards involve microbiologic examination of fluid taken from the affected joint. This procedure can require the patient to be sedated, and the fluid culture analysis can take up to 72 hours. A single laboratory measure that could be easily obtained and quickly analyzed would aid in faster diagnosis, fewer diagnostic tests and lower cost of the diagnostic work-up for this condition.

Recent research on septic arthritis has identified procalcitonin as a potential septic arthritis diagnostic indicator. Procalcitonin (PCT) is secreted by cells in the thyroid at higher levels when the body is facing infection. Procalcitonin levels rise slowly over the first two hours and peak at 24 hours. Levels rise 100-fold in the peripheral blood stream during this time frame. Several studies have indicated PCT is promising potential diagnostic indicator for septic arthritis. Unfortunately, many of these studies have relatively small sample sizes and very few involve pediatric populations. Additional study of PCT and septic arthritis in children will help evaluate the viability of PCT as a diagnostic indicator.

Research Question:

Can serum procalcitonin assist in clinical differentiation between bacterial (septic) and non-bacterial arthritis?

Methods:

Patients presenting with possible septic arthritis in the emergency department will be recruited for this study. Patients who consent to participate will receive the current standard for care, including IV placement, laboratory tests for Erythrocyte sedimentation rate (ESR),white blood cell count (WBC), and C-reactive protein (CRP), x-rays and consultation with pediatric orthopedics. Patients participating in the study will have a portion of the serum collected for typical diagnostic tests analyzed for PCT. Research assistants will collect data from medical records of participants, including lab and imaging results. Patients who do not undergo surgery will be contacted by phone within 7 days of their ED visit to confirm diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. Are 0 - 16 years of age (inclusive)
2. Have a painful, swollen, monoarticular joint
3. Are suspected of having a septic joint
4. Are able to provide assent and parents provide informed consent

Exclusion Criteria:

1. Have reached anatomical maturity indicated by a closed physis in the joint of interest
2. Have neuromuscular and/or metabolic disease
3. Have a chromosomal disorder affecting chromosome 11 in the region of the CALC-1 gene
4. Have received antibiotics within 7 days of the ED visit
5. Are immune deficient
6. Have had surgery in within the last 7 days
Inhibitory Receptors in Eosinophils of Atopic Subjects

The purpose of this study is to analyze the expression and activity of inhibitory molecules on eosinophils obtained from allergic subjects.


Eligibility Criteria:
Inclusion Criteria:

* age 20-60 years
* a physician-diagnosed atopic disease

Exclusion Criteria:

* atopic disease not active
* steroid treatment
* active non-atopic inflammatory disease, including infections
* pregnancy
Investigation of the Effect of E.-Coli-Nissle as Supporting Therapy to Standard Care of Diabetes Mellitus Type II

This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to antidiabetic standard care in patients with diabetes mellitus type II


Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus type 2;
* HbA1c \>7 % (stable für 6 months, max. variation of 0,5%)
* stable oral antidiabetic therapy for 6 months with Metformin, Vildagliptin, Gliniden or without oral Antidiabetics
* age of 45 to \<80 years (men and women)

Exclusion Criteria:

* Myocardial infarction or stroke within the last 5 years
* Therapy with acarbose
* Acute peripheral arterial disease within the last 12 months
* Instable metabolic situation
* Uncontrolled hypertension
* Body-Mass-Index ≥ 35 kg/m²
* Smokers
* Daily consumption of probiotic food
* Malignant disease within the last 5 years
* Status post transplantation
* Immunosuppressive therapy within the last 3 months
* Therapy with antibiotics
* Macroalbuminuria
* Severe liver disease
Expressive Helping for Chinese-Speaking Cancer Patients and Survivors

This study examines the feasibility, cultural-sensitivity, and health effects of the expressive helping intervention by conducting a single-arm trial with Chinese-speaking cancer patients and survivors.

This study examines whether expressive helping is feasible and culturally-sensitive for Chinese American cancer patients and survivors. For 20 minutes each week over four weeks, participants choose to write or voice-record their thoughts about cancer by following specific prompts designed to help them process their cancer experiences. During the last week of this reflection exercise, participants write or voice-record an anonymous letter to another Chinese cancer patient by sharing their cancer experience and providing advice and encouragement. Health outcomes are assessed at baseline, 1-month, and 3-month follow-ups. A subset of the participants will be invited to share their experiences with the study through qualitative interviews after the last writing/voice-recording session. This research study provides an opportunity for Chinese American cancer patients and survivors to express their feelings without the fear of burdening others, and give them an opportunity to help others by sharing their cancer experiences.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer (any type)
* Of Chinese descent
* Over the age of 18
* Can speaking and read Mandarin Chinese

Exclusion Criteria:

* Completed primary cancer treatment more than five years ago
Gut Microbes and Metabolic Group in Different PBC Patients for UDCA Response

To compare intestinal flora diversity in different PBC patients with UDCA responses, and further study the differences of bile acid metabolism and short chain fatty acid metabolism in feces and serum of two groups of PBC patients.

The PBC patients have been enrolled in the study for UDCA treatment more than 1 year, who is divided into the UDCA total response Group and the other poor response group according to Paris-I/II standard .The feces of two groups of patients were collected and the differences of microbial polymorphism of fecal microorganism in two groups were observed. The metabolic differences of bile acids and short chain fatty acids in serum and feces of two groups of PBC patients were studied by means of metabolic proteomics.

Eligibility Criteria:
Inclusion Criteria:

1.Confirmed diagnostic criteria about PBC, and orally UDCA treatment for more than a year; 2.30-70 years old; 3.Currently only UDCA therapy, not glucocorticoids and immunosuppressor treatment.

Exclusion Criteria:

1. Viral liver disease;
2. alcoholic liver disease;
3. fatty liver;
4. drug-associated liver damage;
5. infectious disease;
6. obesity;
7. gastrointestinal diseases;
8. combined with other autoimmune diseases;
9. cardiac and pulmonary dysfunction;
10. renal dysfunction, malignant tumor,;
11. neurological and psychiatric abnormalities;
12. nearly 2 months to take antibiotics and probiotics;
13. nearly 3 months participate in other drug clinical trials .
Scapular Stabilization Exercises Versus Eccentric Muscle Energy Techniques in Patients With Upper Crossed Syndrome

This study will be a Randomized Clinical Trial in which Scapular Stabilization Exercises and Eccentric Muscle Energy technique will be applied on the individuals with upper crossed syndrome and changes will be recorded using different method and tools. Convenient sampling technique will be used to collect the data. The sample size of 34 patients will be recruited. Patients will be randomly allocated into two different groups through sealed envelope method. 17 patients will be allocated in each group. Group A will be treated with Scapular Stabilization Exercises along with hot pack; Group B will be treated with Eccentric Muscle Energy Technique along with hot pack. Craniovertebral Angle (CVA), Numeric Pain Rating Scale (NPRS), and Neck Disability Index (NDI) will be used as Data collecting tools.

Upper Crossed Syndrome is defined byJanda as the involvement of different muscles of skeletal system which leads to shortness and tightness of anterior and upper trunk or weakness of posterior part of skeletal muscles. Alteration of muscles activity such as facilitation of different muscles as levator scapula, sternocleidomastoid, pectoralis muscles and inhibition of cervical flexors, serratus anterior The muscular imbalance occurs because of weak/tight and tonic muscles. Neck pain is the most frequent problem in developed countries. The prevalence of neck pain is approximately 10-15%. Neck pain is the most common reason for patients visiting healthcare professionals. Poor posture typically causes upper cross syndrome (UCS), resulting in neck pain. This syndrome can cause dysfunctional tone in posture and muscular disparity of head, neck and shoulder region.

Eligibility Criteria:
Inclusion Criteria:

* • Age: participants having range 18-35 years both male and female are included.

  * Craniovertebral angle\<52
  * NPRS\>3 and NDI\>10
  * Patients having neck pain during movements.
  * Patients having neck pain due to sustained posture and after activity

Exclusion Criteria:

* Inflammation malignancy, neurological disorder
* Metabolic disorders
* Neck pain radiating into arms and upper extremity
* Neck pain associated with headache and facial pain
* Recent surgery
* History of recent trauma and fractures of cervical spine
* Patients having any other therapeutic intervention or medical treatment.
Optical Coherence Tomography for Drug Eluting Stent Safety

Increasing lesion complexity in percutaneous coronary interventions (PCI) has warranted the use of overlapping drug-eluting stents. Whether the substantial impairment of arterial healing observed at sites of overlap in preclinical pathologic studies persists in patients undergoing PCI is unknown. Consecutive patients with long lesions in native coronary vessels requiring stents in overlap are prospectively randomized to receive multiple sirolimus-,paclitaxel polymer-or zotarolimus eluting stents versus bare metal stents. The completeness of stent struts coverage and/or late malapposition are evaluated by Optical Coherence Tomography at 6 months follow-up

If overlapping drug-eluting stents provide increased vessel toxicity is not known. Given the association of delayed healing and incomplete endothelialization observed in animal and human autopsy studies at overlapping sites it is unclear why most patients do well with multiple DES implanted. OCT detecs smaller degrees of in-stent neointima more accurately than IVUS and might be a useful method for identify strut coverage and/or malapposition.

Patients if eligible on the basis of clinical and angiographic criteria, are randomized (2:2:2:1) to receive multiple TAXUS Libertè™ vs Cypher Select™ vs Endeavor™ vs Libertè BM stents, in overlap. Stent implantation are done accordingly to the normal interventional practice. QCA and IVUS are performed at the end of optimal stents placement per visual judgement (residual stenosis \< 10%, TIMI 3 flow). Stent, lumen size and volume as well as complete stent strut apposal will be determined by IVUS analysis. Clinical follow-up will take place at 1 month (±1 week), 6 months (±2 weeks) and 1 year (±2 weeks). At 6-months follow-up all patients will undergo a quantitative coronary angiography (QCA), IVUS and Optical Coherence Tomography (LightLab OCT Imaging M2, automated pull back and flushing combination)assessments.

OCT images will be acquired at 15-30 frames per second. Blind corelab quantitative strut by strut analysis will be performed using a novel dedicated software at each 0.5 mm section. The following OCT variables will be evaluated:number of visualized strut per section, mean-max neointimal thickness per section, % struts well apposed with neointima at overlapping vs non overlapping sites, % struts without neointima, % struts malapposed, rate of \> 30% uncovered struts/total number of struts per section.

Eligibility Criteria:
Inclusion Criteria:

1. Native coronary artery disease with ≥ 75% diameter stenosis
2. Lesion length ≥ 20 mm,
3. Vessel size in between 2.5 and 3.5 mm.
4. Multiple, overlapped DES vs BMS placement (intention to overlap ≥ 4 mm)
5. Signed patient informed consent

Exclusion Criteria:

1. left main coronary artery disease,
2. lesions in coronary artery bypass grafts,
3. acute myocardial infarction,
4. poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%.
5. allergy to aspirin and or clopidogrel/ticlo,
6. renal failure with creatinine value \> 2.5,
7. no suitable anatomy for OCT scan