cyrilzakka/clinical-trials huggingface dataset:
Combination Drug Study of Bexarotene and Rosiglitazone to Treat CTCL

The purpose of this trial is to determine if combination therapy with rosiglitazone and bexarotene might have a synergistic effect in the treatment of patients with CTCL.

Treatment options for CTCL include both skin-directed and systemic therapies. Topical treatments are effective for early-stage disease that is localized to the skin. However, disease involving the lymph nodes or visceral sites can be palliated but rarely cured, even with the most aggressive regimens of systemic chemotherapy. Unfortunately, current treatment options at this stage only provide a short term response. Thus, it is important that additional therapies are investigated to manage this malignancy.

Bexarotene has been approved by the FDA for the treatment of Cutaneous T-Cell Lymphoma (CTCL).Bexarotene binds the RXR(Retinoid X Receptor)inside the cell, a receptor that forms heterodimers with a multitude of other nuclear receptors. One of these is the PPARγ (Peroxisome Proliferator Activator Receptor Gamma), a nuclear receptor that binds Rosiglitazone.Rosiglitazone is an FDA approved antidiabetic agent of the Thiazolidinedione class. Rosiglitazone increases insulin sensitivity and is useful in the treatment of type 2 diabetes. In vitro data suggest that rosiglitazone and bexarotene may act synergistically to induce apoptosis in cell lines derived from patients with cutaneous T cell lymphoma (CTCL). This pilot study will investigate this possible synergism in a small cohort of patients with stable or progressive CTCL already being treated with bexarotene.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy proven persistent or recurrent cutaneous cell lymphoma (CTCL) Stage IA-IVA
* Patients with a pathologic proven diagnosis of CTCL that is documented in the patient history.
* Patient has preserved organ function.
* Patient has an ECOG performance status between 0 - 2.
* Women of childbearing potential should be screened for pregnancy prior to treatment and utilize effective contraceptive methods (e.g. barrier) during treatment period.
* Patients over the age of 18 who are willing and able to provide Informed Consent
* The patient has been taking Targretin capsules for at least the last 4 months and the dose has remained relatively stable.
* The patient has had stable or progressive disease over the past 4 months.
* Patient has adequate laboratory parameters for liver and kidney function.

Exclusion Criteria:

* Patients with CD30+ Anaplastic Large Cell Lymphoma
* Patients with pathology consistent with peripheral T-cell lymphoma.
* Patients with Stage IVB (visceral involvement with CTCL).
* Patients with history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection.
* Patients with a diagnosis of congestive heart failure.
* Patients exhibiting significant edema or unstable cardiovascular disease.
* Patients with a fasting triglyceride level greater then 500mg/dl.
* Patients that have started any new treatment for CTCL in the past 4 months.
* Pregnant women will be excluded from the study.
Oxidized Regenerated Cellulose to Decrease Vaginal Cuff Complications

The goal of the investigators study is to determine whether the use of oxidized regenerated cellulose reduces the risk of vaginal cuff cellulitis, pelvic abscess, or vaginal cuff dehiscence in patients undergoing laparoscopic hysterectomy. The investigators hypothesize that the use of oxidized regenerated cellulose will reduce the risk of vaginal cuff cellulitis, pelvic abscess, and vaginal cuff dehiscence in patients undergoing laparoscopic hysterectomy.

Structured non-woven absorbable hemostat (or oxidized regenerated cellulose) was designed and marketed for its hemostatic properties. It is used in our practice to achieve hemostasis at the site of the vaginal cuff closure during laparoscopic hysterectomy. While the hemostatic properties of oxidized regenerated cellulose are well known and documented, there is newer research to suggest that oxidized regenerated cellulose may have antimicrobial activity. One In vitro study investigated the antimicrobial activity of oxidized regenerated cellulose products against multiple antibiotic resistant microorganisms and found that the antimicrobial affect of the oxidized regenerated cellulose products was significantly greater than that of the controls. There are a limited number of studies investigating the antimicrobial activity of oxidized regenerated cellulose products in vivo (and none in gynecologic surgery).

Eligibility Criteria:
Inclusion Criteria:

* female, ages 20-80, undergoing laparoscopic hysterectomy

Exclusion Criteria:

* malignant indications for hysterectomy
Effects of Intensive Chiropractic Care to Usual Care for Adults With Spinal Cord Injuries.

To determine the effects of chiropractic care on spasticity, functional outcomes and quality of life in Spinal Cord Injuries in adults.


Eligibility Criteria:
Inclusion Criteria:

* Adults with both genders (Male and Female).
* Age above 20 years.
* Spinal Cord Injuries adults.

Exclusion criteria

* Spinal Cord Injury due to Traumatic Brain Injury.
* Patients having cognitive impairments.
* Patients having associated Neurological Pathologies.
* Patients who are unable to follow the treatment plan.
Pivotal Assessment of the Effects of Bioactive on Health and Wellbeing. From Human Genome to Food Industry

This is a multi-centre, randomised, double-blind, placebo-controlled, parallel-arm dietary intervention study. In total, 800 men and women at risk for Metabolic Syndrome (MS) will be recruited. Subjects will be eligible to the study if they present with two to four of the MS diagnostic criteria, at least one of them being:

* fasting triglycerides ≥150 mg/dL but ≤400 mg/dL OR
* HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110 mg/dL).

Each of the four recruiting centres will recruit 200 volunteers. Participants will be randomly assigned to one of four groups to receive either:

* Dairy BEF + egg placebo + bakery placebo
* Egg BEF + dairy placebo + bakery placebo
* Bakery BEF + dairy placebo + egg placebo
* Dairy, egg and bakery placebo

Participants will be required to consume all three of the allocated products each day for 12 weeks.

Eligible volunteers will be included and randomly allocated to one of the four groups. At baseline, 6 weeks and 12 weeks after inclusion, each participant will visit the recruiting centre for clinical and biochemical investigations. At 3 weeks and 9 weeks participants will complete questionnaires relating to their satisfaction with the food products, compliance to consumption of the study food products, and any gastrointestinal side effects or health-related adverse events that have occurred in the previous 3 weeks.

At each recruiting centre 40 participants will be required to take part in additional activities, these are: stool sample collection, adipose tissue aspiration, body composition analysis by dual energy x-ray absorptiometry (DEXA) and assessment of physical activity.


Eligibility Criteria:
Inclusion Criteria:

* subjects presenting with two to four diagnostic criteria for metabolic syndrome, at least one of them being elevated fasting triglycerides OR HDL-cholesterol ≤50 mg/mL in women, ≤ 40mg/mL in men (with fasting triglycerides ≥110 mg/dL).

Exclusion Criteria:

* subjects with five clinical criteria for metabolic syndrome
* Regular drug therapy with impact on serum lipids;
* Diabetes (fasting glucose \> 1.26 g/L, or anti-diabetic treatment);
* Celiac disease, lactose intolerance, allergy to milk or egg proteins;
* Antibiotic treatment within the last 3 months;
* Recent history of cancer or cancer treatment (less than 2 years);
* Active or recently diagnosed intestinal malabsorption;
* Diagnosis of organ failure
* Familial dyslipidemia (TG ≥ 4.5 mmol/l or 400 mg/dl);
* Illegal drug use or chronic alcoholism or smoking;
* Intensive physical exercise (≥ 5 hour/week);
* Consumption of nutritional supplements containing DHA, BG or AC;
* History of allergy or intolerance to any components used in BEF;
* Women who are pregnant or lactating;
A Prospective Observational Study of Lymphedema in Breast Cancer With Axillary Lymph Node Dissection

Over the past few years, several studies have been made on various outcomes about the incidence of lymphedema. Because the outcomes can be came out differently each study by measurement, criteria, treatment period, treatment method and morbid extremities of lymphedema. Therefore it is required for understanding about the incidence, risk factor and physical progress for to be treated and prevented of lymphedema. Also it is necessary that to understand characteristics of lymphedema measurements and to establish diagnostic criteria of lymphedema through comparative study.

The aim of this study was to analyze the incidence and risk factor of lymphedema through prospectively observation, and to determine effects on the quality of life of lymphedema after breast cancer surgery with ALND.

Primary Objectives:

- To analyze incidence rate of lymphedema using tape measurements, perometre, bioimpedance, spectroscopy.

Secondary Objectives:

* To determine the risk factor of lymphedema in postoperative breast cancer.
* To understand that lymphedema has an effect on quality of life and physical function in postoperative breast cancer.
* To complete uestionnaire about physical and quality of life in postoperative breast cancer with ALND patients.

Eligibility Criteria:
Inclusion Criteria:

* Older than 20 years old
* Patient who underwent unilateral Breast Cancer surgery with ALND
* Informed consent must to be signed

Exclusion Criteria:

* Previous history of breast cancer
* History of abnormality or vascular disease in upper extremity
* Patients with other serious systemic illness (renal failure, hepatic dysfunction, congestive heart failure, neurological or psychological impairment) that would confound the study or impair the patients' ability to participate.
* History of infection on upper extremity
* History of corticosteroid use on whole body for any reason
* Inability to provide informed consent (e.g. dementia or severe cognitive impairment)
6 FEC 100 Vs 4 FEC 100 Followed by 4 Taxol in N+ Breast Cancer

The main objective of this randomized trial is to compare 6 FEC100 to 4 FEC100 + 4 Taxol in patients with resected node positive breast cancer. Main endpoint is disease free survival. Secondary endpoints are overall survival, time to local recurrence, time to distant metastases, and tolerance. A total of 840 patients have been included in the trial.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven cancer of the breast,
* Mastectomy or complete tumorectomy,
* Histologically proven homolateral, axillary lymph node involvement (at least 1 N+)
* Period between surgery (second operation in case of primarily incomplete resection) and the start of chemotherapy \< 2 months,
* Biological criteria (before the first FEC cycle):

  * Neutrophils \>1.5 109 /L
  * Platelets \>100 109/L
  * Hemoglobin \>10 g/dl
  * Creatininemia \<120 mmol/1
  * Bilirubinemia \<1.5 Upper normal value
* Female patients over 18 years old
* Written and signed informed consent
* Performance Status less than or equal to 2 (WHO scale, see Annex IV)

Exclusion Criteria:

* Prior chemotherapy or radiotherapy, including neo-adjuvant treatment for cancer of the breast,
* Bilateral breast cancer or history of contralateral breast cancer
* Cardiac history: cardiac insufficiency (LVEF \<50%) or coronary decompensation
* Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential)
* Inflammatory breast cancer
* Distant metastasis or supraclavicular adenopathy
* Benign pathology or history of malignant pathology accompanied by a life expectancy of less than two years
* Contra-indication to Anthracyclines, Cyclophosphamide, 5FU or Taxol
* Psychiatric pathology
* Patient participating in another trial
Efficacy of the Brushless Scrub

The aim of this research is to examine if the brushless scrub is effective in reducing bioburden on the hands of the operating room (OR) personnel both with a prewash of one minute prior to scrub and without a prewash prior to scrub, and to compare the bioburden reduction between both methods.

Hypothesis I: A soap and water prewash used prior to brushless scrub further decreases bioburden than brushless scrub alone.

Hypothesis II: Brushless scrub is effective in reducing the bioburden measured just after the application of the brushless scrub within 20 seconds of application for both groups.

Exploratory Hypothesis: We will also compare the bioburden measured before and at 1.5 minutes after application of the brushless scrub for both groups.

Hand washing by operating room personnel prior to surgical procedures is essential in the prevention of intraoperative infection. The use of the brushless surgical hand hygiene has been used since the CDC stated in 2002 that using a brush and sponge is no longer necessary. Empirical literature supports the reduction of the incidence of bacteria or OR personnel hands with the use of alcohol-based products.

An annotated integrative search of the literature was conducted and conflicting information regarding the use of a prewash prior to the brushless scrub was found. This study can help us utilize the brushless scrub to the fullest capacity and prevent surgical site infections.

The time point at which the outcome measure will be assessed at an individual level will be immediately pre-intervention and also 1.5 minutes after the intervention. For example, within 15 seconds prior to brushless scrub, or prewash, a sample swab will be collected and then another sample swab will be obtained 1.5 minutes later for postintervention measure. The study should take approximately 4 months to complete to get an adequate sample size of individuals for statistical power. The data will be aggregated and presented at a staff in-service within 3 months after data collection and analysis is completed.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion will consist of all OR personnel and students who scrub for surgical procedures.

Exclusion Criteria:

* Exclusion will consist of any OR personnel and students whom do not want to participate in the study or those who have not been part of the the routine and mandatory training of proper surgical hand hygiene which occurs annually.
PTCY Plus uhCG/EGF for Graft Versus Host Disease Prophylaxis

So this a Phase I study with primary objective to determine the feasibility and safety of combining post-transplant cyclophosphamide and urinary-derived human chorionic gonadotropin and epidermal growth factor (uhCG/EGF) as graft versus host disease prophylaxis in stem cell transplant with MMUDs Secondary objectives are to determine the incidence acute and chronic GVHD, progression-free survival , and overall survival


Eligibility Criteria:
Inclusion Criteria:

1. Patients with hematologic malignancy who have the indication for Allogeneic SCT and have no MRD or MUD.
2. Age 18-70 years old
3. Performance score of at least 80% by Karnofsky
4. Adequate kidney and liver function as demonstrated by:

   1. Creatinine clearance should be \>60 ml/min
   2. Total Bilirubin \<1.5, ALT/AST/Alk Phos \< 2.5 x normal. No evidence of chronic active hepatitis or cirrhosis.
5. Negative Beta HCG test in a woman with childbearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization. Women of childbearing potential must be willing to use an effective contraceptive measure while on study.
6. Patient or patient's legal representative, parent(s) or guardian able to sign informed consent.

Exclusion Criteria:

1. Positive for HIV, HBsAg, HCV or other viral hepatitis or cirrhosis from any cause
2. Active or prior CNS leukemia, unless in complete remission for at least 2 months.
3. History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs.
4. Uncontrolled infection
5. Donor specific antibodies
6. Ejection fraction \<40% or history of heart failure or cardiovascular disease
7. history thrombosis or current thrombosis, family history of thrombosis, severe obesity, or thrombophilia.
8. Previous history hormone responsive cancer
9. history of seizure
10. history of migraine or severe headache
11. history of asthma
12. history of uterine fibroid
Ioxaglate Versus Iodixanol for the Prevention of Contrast-induced Nephropathy in High-risk Patients (IDPC Trial)

Contrast media-induced nephropathy following diagnostic and therapeutic cardiac catheterization.

Contrast-induced acute kidney injury represents a serious complication of procedures requiring administration of iodinated contrast media and is associated with the need for dialysis, prolonged hospitalization, increased costs, and mortality.

Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.

Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium may be less nephrotoxic than low-osmolar contrast media in high-risk patients.

The purpose of this study is to compare iodixanol versus ioxaglate in high risk patients between 48 and 96 hours after procedures that use contrast.

Eligibility Criteria:
Inclusion Criteria:

At least one of the following criteria

* Aged more than 70 years-old
* Chronic renal failure
* Diabetes mellitus
* Congestive heart failure - left ventricular ejection fraction \< 0.50
* Shock or intra-aortic ballon pump use
* Urgency or emergency procedures

Exclusion Criteria:

* Patients in dialysis
* Allergy to iodine
* Patient refusal to informed consent
Prevention of Drug Use in Adolescence: Intervening in Parenting Styles

To investigate whether brief motivational intervention is associated with the change of parenting style in parents of teenagers seeking to prevent drug use among their children.


Eligibility Criteria:
Inclusion Criteria:

* Parents of adolescents aged 10-15 years who call for the service call 132 looking for a program to prevent drug use and accept to participate in the study after reading the Statement of Consent

Exclusion Criteria:

* Be excluded individuals that are experiencing difficulty in answering the questions and those who refuse to participate in the study elucidated by IC
The Clinical Trial About Treatment of Benign Uterus Myoma by Haifu Focused Ultrasound Tumor Therapeutic System

Uterine benign tumor including myoma is the most common female benign pelvic tumor. Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) has been considered to be a minimal invasive treatment. The device used in this trial will be Haifu Focused Ultrasound tumor therapeutic System. In this trial, the investigators will observe the possibility of complication and tumor response of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Benign uterine fibroids.
2. Women over the age of 20.
3. Abdominal circumference \<100 cm.
4. The largest fibroids are ≥ 4 cm.

Exclusion Criteria:

1. Pregnant women or those with positive pregnancy test results.
2. Those with other pelvic diseases.
3. Those with immune diseases.
4. There are unsuitable interfaces in the ultrasonic treatment path.
5. Those with tumor calcification.
6. People with severe heart, blood vessel and kidney disease.
7. Those with abnormal coagulation function and low platelets.
8. Type III fibroids according to Funaki classification
Clinical and Ecological Impact of a Primary Care Antimicrobial Stewardship Program Based on Telematic Educational Interviews (TELÉMACO Trial)

Brief Summary: Open-label, cluster randomized, multicenter clinical trial to evaluate the clinical and ecological impact of a Primary Care ASP based on telematic educational interviews.

The objective of this project is to measure the effect of an Antimicrobial Stewardship Program (ASP) in Primary Care, based on an educational intervention.

This will consist of periodic structured telematic educational interviews between Infectious Diseases experts and Family Medicine and paediatrics specialists. In these interviews, the principles for the optimal use of antimicrobials will be addressed on real cases, analyzing together prescriptions randomly chosen from the Primary Care physician himself.

The repetition over time of key pedagogical messages for the optimisation of prescriptions is expected to improve the quality of antibiotic use, reduce the overall consumption, improve the use of microbiological tests, reduce the incidence of community infections caused by resistant microorganisms, and preserve patients' safety measured by the rate of admission for serious infections.

The results derived from these educational interventions, in the framework of a multimodal ASP, have been evaluated in hospital and Primary Care settings in quasi-experimental studies with a favourable outcome, but not in a clinical trial that specifically assesses the efficacy of educational interviews and avoids the bias of uncontrolled studies. To demonstrate this hypothesis, a cluster randomized trial has been designed, in wich all healthcare centers will be assigned either to a control group (the standard measures defined by the regional ASP PIRASOA will be maintained), and an experimental group (whose physicians will receive the educational intervention described).

Eligibility Criteria:
Inclusion criteria:

a) Primary Care centres within the reference area of the University Hospital Virgen del Rocío.

Exclusion criteria:

1. Emergency departments.
2. Odontology offices.
3. DDD per Health centre less than 5.78
Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis

Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid Arthritis


Eligibility Criteria:
Inclusion Criteria:

* Male or Female ages 18 years and older.
* Mild RA.
* Body weight less than 100 kg.

Exclusion Criteria:

* Wheelchair-bound or bedridden.
* Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit.
* Intra-articular, intramuscular or intravenous (IV) administration of corticosteroids within 28 days prior to the Screening visit.
* Prior treatment with any TNF antagonist, including adalimumab.
* Positive tuberculin PPD 5.
* Female subjects who are pregnant or breast-feeding.
* History of HIV or of being immuno-compromised.
* History of malignancy.
* Poorly controlled medical condition.