cyrilzakka/clinical-trials huggingface dataset:
FOLFOX-Cetuximab-radiotherapy for the Treatment of Esophageal Cancer

This phase II trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when given together with Cetuximab and radiation therapy and radiation therapy to see how they work in treating patients with stage III esophageal cancer.

Cetuximab is a monoclonal antibody which can block the ability of tumor cells to grow and spread Cetuximab may also make tumor cells more sensitive to radiation therapy. Drug used in chemotherapy such as oxaliplatin leucovorin and Fluorouracil work in different way to stop the growth of tumor cells either by killing the cells or by stopping them form dividing. Radiation therapy uses high energy X rays to kill tumor cells. Giving cetuximab could improve the efficacy of chemotherapy and radiation therapy and may make the tumor smaller This phase II trial is studying the effects of oxaliplatin, leucovorin and fluorouracil-when given together with Cetuximab and radiation therapy and radiation therapy to see how they work in treating patients with stage III esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of the esophagus stage III (according to UICC classification)
* Measurable disease according to the RECIST criteria
* WHO performance status of 0 or 1
* Age 18-80 years old
* Reference imaging within the 2 weeks prior to the treatment
* Hematological and biochemical assessment within the 2 weeks prior to the treatment
* Neutrophils \>1.5 10 9/L, platelets \>150.10 9/L, Haemoglobin ≥10g/dL, Bilirubin ≤ 1.25 ULN, Aspartate Aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3 ULN Woman of childbearing potential must use effective contraception methods Written informed consent obtained No prior chemotherapy or radiation therapy for esophageal cancer

Exclusion Criteria:

* Stage I, II or IV (according to UICC classification)
* Esophageal carcinoma with small cells or endocrine cells or esophageal stromal tumor
* visceral metastasis
* orotracheal fistula weight loss \>15% within the previous 6 months Pregnancy or breast feeding Contra indication to the study treatment History of coronary heart disease uncontrolled, or myocardial necrosis within the previous 6 months
* Peripheral Neuropathy NCI \>1
* Liver Failure
* Prior thoracic radiation therapy
* history of cancer within the previous 5 years (except removed skin carcinoma, removed local melanoma located, and carcinoma cervix of uterus Esophageal Endoprosthesis
Long-term-opioid-free Anesthesia in Anterior Cervical Surgery

We design this randomized controlled trial to explore the safety and efficacy of the long-term-opioid-free anesthesia in anterior cervical surgery, to reduce the dosage of perioperative long-acting opioids and promoting patients'rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing anterior cervical surgery., sign the "informed consent form"
* Age above 18 years old
* ASA Ⅰ-Ⅲ.

Exclusion Criteria:

* Pregnant or lactating women.
* Patients with history of drug abuse, including but not limited to opioids, amphetamines, ketamine, etc
* Allergic to the materials or drugs used in this study.
* Patients with current/previous gastrointestinal bleeding and gastric ulcers;
* Have history of nervous system diseases such as peripheral neuropathy, or psychiatric mental illness.
* Other conditions that the investigators consider unsuitable for participation in the study, such as deaf, Parkinson's disease, and difficult to communication etc.
Long Term Clinical Implications in Chinese Patients With Aortic Intramural Hematoma

The study evaluates outcomes of intramural hematomas after long-term follow up and establish predictive factors in Chinese population.

270 intramural hematoma patients with clinical and imaging follow up were retrospectively studied in present study. The primary endpoint was consisted of aortic disease-related death, aortic dissection, penetrating atherosclerotic aortic ulcer , thickening of aorta hematoma and aortic complications requiring surgical or endovascular treatment.

Eligibility Criteria:
Inclusion Criteria:

* Type A aortic hematoma
* Type B aortic hematoma

Exclusion Criteria:

* Aortic without initial intimal flap formation.
Wireless Assessment of Respiratory and Circulatory Distress; A Pilot Study

Postoperative observation of patients is based on the Early Warning Score (EWS). By using continuous wireless monitoring of vital parameters it may be possible to predict the risk of complications after abdominal cancer surgery. The object of this pilot study is to test the equipment and methods for the next phases. Patients will be monitored for 4 days postoperatively and data is analyzed retrospectively. Vital parameters are monitored with ECG, blood pressure monitor and pulseoximetry.

In the analysis the investigators will compare the results from the continuous monitoring to the measurements made by the nurses and registered in the EWS. The primary outcomes for the pilot study are the frequency of measurements resulting in a single parameter score of 3 according to the EWS algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer of either esophagus, stomach, pancreas, liver, colon or rectum.
* Elective surgery with curative intention at Bispebjerg Hospital or Rigshospitalet in Copenhagen, Denmark.
* Estimated duration of surgery \> 2 hours
* \> 65 years
* Preoperative ECG showing sinus rhythm
* No treatment limitations
* Fit to receive optimized care according to the regimens on the given wards
The Optimal Oblique and Axial Angle of Fluoroscope for Superior Hypogastric Plexus Block

The recommended entry angle for superior hypogastric plexus block is different among references, and there is a need for suggesting a more accurate entry angle for this procedure. The investigators are trying to evaluate the entry angle for superior hypogastric plexus block by measuring these angle on the computed tomography image and apply these angle to the real patients.

Superior hypogastric plexus block is a kind of sympathetic plexus block which are used to control the pelvic pain caused by malignancy or other chronic condition. Classic posterior approach for this procedure is inserting the block needle at L4 -5 level and proceed the needle 45 degrees medially and 30 degrees caudally to reach the target of anterolateral space of L5 - S1 intervertebral space. Waldman et al. introduced a different angle of 30 degrees medial and caudal with the same approach, while Stevens et al. recommended 15 degrees medial and 20 degrees caudal. As such, the recommended angle for this procedure is different among references, and there is a need for suggesting a more accurate entry angle for this procedure. Therefore, we are trying to evaluate the entry angle for superior hypogastric plexus block by measuring these angle on the computed tomography image and apply these angle to the real patients.

Eligibility Criteria:
Inclusion Criteria:

* Those undergoing abdominopelvic CT scan with pelvic malignancy or chronic pelvic pain with constitutional disease

Exclusion Criteria:

* Poor CT image with non-measurable axial or oblique entry angle
Interest of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Auditory Hallucinations

Auditory hallucinations are common (present in 60-70% of cases) and extremely debilitating. Behavioral disorders associated with them can have serious social repercussions. However, in 25% of cases the usual antipsychotic drug treatments are incompletely or totally ineffective.

Fifteen subjects will be included after collection and signed their informed consent.

The rTMS treatment is made of 4 sessions of 13 minutes spread over two days, at a frequency of 20 Hz and an intensity of 80% of motor threshold at rest. These constants are used to stay below the risk of occurrence of seizures, the only serious side effects identified. Furthermore the rTMS treatment is almost painless: tension headaches are the main side effects and make amends with simple analgesics. rTMS is devoid of neurocognitive effects. The LEFT stimulation site will be established through a anatomofunctional imaging before treatment (between D-7 and D0).

Treatment efficacy will be evaluated daily during treatment (days 1 and 2) and during the first 2 weeks of starting treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with schizophrenic disorders aged from 18 to 60 years old
* Patients suffering from auditory hallucinations undergoing antipsychotic treatments
* Written signed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* Counter-indication to MRI or to rTMS
Evaluating Huddles As a Novel Approach to Improving Concussion Safety

Investigators will conduct a randomized controlled trial assessing the effectiveness and implementations of Pre-Game Safety Huddles (Huddles) in youth soccer.

The clinical trial portion of this study will enroll 16 youth soccer leagues within four US states. Within each participating league we will enroll two "brackets" (closed units of teams at the same level that compete against each other during the regular season of play) of U12 boys' and girls' U12 teams. Based on typical league and bracket size we anticipate will be 384 teams. Randomization will happen at the league-level. Leagues in the Huddle intervention condition will be supported by US Soccer in implementing Pre-Game Safety Huddles before each regular season game. Leagues in the control condition will continue US Soccer's standard concussion education prevention activities.

Our primary effectiveness and implementation outcomes will be measured at the end of the regular season of play (anticipated to be 10 weeks). Maintenance outcomes will be measured at the end of the regular season of play one year later.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 9 and 13 on eligible teams in participating leagues.
* Soccer coaches of children between the ages of 9 and 13 on eligible teams in participating leagues.
* Read and write English

Exclusion Criteria:

* Cannot read and write English
Selective Laser Trabeculoplasty After Failed Phacoemulsification With Eximer Laser Trabeculectomy

The aim of this study is to evaluate the efficacy of selective laser trabeculoplasty after a prior failed phacoemulsification and Eximer Laser Trabeculectomy.

This study evaluates the efficacy of selective laser trabeculoplasty after a failed combined procedure of phacoemulsification cataract extraction with intraocular lens implantation plus Eximer Laser Trabeculectomy in open angle glaucoma or ocular hypertension. The success of SLT will be determined by the intraocular pressure and number of hypotensive drugs.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of open angle glaucoma or ocular hypertension
* and diagnosis of cataract

Exclusion Criteria:

* diagnosis of angle closure glaucoma
* any optic neuropathy other than glaucoma
Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors

This randomized pilot clinical trial studies pelvic floor muscle training in treating urinary incontinence in gynecologic cancer survivors. Pelvic floor muscle training may help control symptoms and improve physical function and quality of life in gynecologic cancer survivors.

PRIMARY OBJECTIVES:

I. To assess whether pelvic floor muscle training and behavioral therapy in gynecologic cancer survivors results in improvement in incontinence symptoms as measured by a validated questionnaire (Patient Global Impression of Improvement) at three month follow-up when compared to women who do not undergo pelvic floor muscle training.

II. To evaluate whether women who undergo pelvic floor muscle training and behavioral therapy report greater improvement in validated urinary incontinence symptom severity, pelvic floor distress and quality of life measures than women who do not undergo pelvic floor muscle training.

III. To evaluate the acceptability of pelvic floor muscle training (PFMT) among gynecological cancer survivors and to provide preliminary data to inform a power analysis for a larger randomized trial.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive a handout describing behavioral management tips for urinary incontinence, including information and suggestions about optimal volume fluid intake, constipation management, measures to reduce urgency by spreading fluid intake, and avoiding caffeine and other bladder irritants that have proved effective in other intervention trials. Patients undergo PFMT over 20-30 minutes teaching them to contract the pelvic floor muscles correctly and receive feedback to avoid the contraction of abdominal, gluteal or adductor muscles. Patients are asked to perform 3 sets of 10 pelvic muscle contractions with a goal of holding the contraction for 5 seconds daily for 12 weeks and also receive a reminder phone call to address concerns and review the instructions at 4 weeks.

ARM II: Patients receive usual care for urinary incontinence, with an option to join the training program after completion of study.

After completion of study treatment, patients are followed up at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* History of uterine, cervical, ovarian or vulvar malignancy
* Treatment free interval of \>= one year and currently have no evidence of cancer
* Reports urinary incontinence based on screening questionnaire
* Must have a stable address for the three month period

Exclusion Criteria:

* Current clinical evidence of urinary tract infection
* Within three months of failed surgery for urinary incontinence
* Planned surgery for urinary incontinence in the next three months
* Presence of neurologic condition that may impact bladder symptoms such as multiple sclerosis, stroke
* Pregnancy
Variable Pressure Support Trial

In 2008 a new ventilation strategy termed variable Pressure Support ventilation (PSV) was introduced, which is able to increase the variability of the respiratory pattern independent from the inspiratory effort. In experimental lung injury, variable PSV was found to improve gas exchange and decrease the inspiratory effort, while reducing alveolar edema and inflammatory infiltration compared to conventional(non-variable) PSV. Importantly, variable PSV reduced peak airway pressure and respiratory system elastance in a variability dependent manner.In addition, preliminary observations suggest that variable PSV can reduce the work of breathing and improve patient comfort, but it is not known whether this new ventilatory strategy is able to speed the weaning from mechanical ventilation.

Since variable PSV can reduce the mean pressure support, it may lead to a faster reduction of pressure support and, therefore, a shorter weaning period than conventional PSV.

The hypothesis of this study is that variable pressure support ventilation reduces the duration of mechanical ventilation to non-variable (conventional) pressure support ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Duration of controlled mechanical ventilation ≥ 24h
* Availability of a Infinity V500 ventilator (ready to use)
* Informed consent according to local regulations
* Temperature ≤ 39 °C
* Hemoglobin ≥ 6 g/dl
* PaO2/FIO2 ≥ 150 mmHg with positive end-expiratory pressure (PEEP) ≤16 cmH2O
* Ability to breath spontaneously

Exclusion Criteria:

* Participation in another interventional trial within the last four weeks before enrollment in this trial
* Peripheral neurological disease associated with impairment of the respiratory pump
* Muscular disease associated with impairment of the respiratory pump
* Instable thorax with paradoxical chest wall movement
* Planned surgery under general anesthesia within 72 hours
* Difficult airway/intubation
* Existing tracheotomy at ICU admission
* Expected survival \< 72 hours
* Home mechanical ventilation or on chronic oxygen therapy
* Suspected pregnancy
Rye Bread Trial; Antioxidative and Cholesterol Lowering Effects

The purpose of this study is to investigate the antioxidative effects of alkylresorcinols (AR), originating from the rye fiber, on serum LDL particles and the use of AR or it's metabolites as biomarkers for rye fiber intake and the effect of additional plants sterols, incorporated in the rye bread, on serum total and LDL cholesterol concentration.


Eligibility Criteria:
Inclusion Criteria:

* healthy
* volunteer
* hemoglobin above 125 mmol/L in females, above 135 mmol/L in males

Exclusion Criteria:

* taking drugs affecting plasma lipids or gastrointestinal track
* severe illness
* use of antibiotics within 3 months before entering the study
* use of vitamin pills or fish oil 1 month before entering the study
* pregnancy or lactating
Telmisartan+Amlodipine Fixed Dose Combination in Hypertension

The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan 80mg/Amlodipine 5mg in patients with moderate to severe hypertension


Eligibility Criteria:
Inclusion criteria:

1. Aged at least 18 years at the date of signing the consent form
2. For treatment-naïve patients: hypertension defined by a mean seated diastolic blood pressure (DBP) equal or more than 100 mmHg measured by manual cuff sphygmomanometry at visit 1 and 2; For pretreatment patients: hypertension defined by a mean seated diastolic blood pressure equal or more than 90 mmHg at visit 1 and equal or more than 100 mmHg at visit 2 measured by manual cuff sphygmomanometry
3. 24-hour mean diastolic blood pressure equal or more than 85 mmHg at baseline Ambulatory Blood Pressure Monitoring

Exclusion criteria:

1. mean seated systolic blood pressure equal or more than 200 mmHg and/or mean seated diastolic blood pressure equal or more than 120 mmHg
2. any clinically significant hepatic impairment
3. severe renal impairment
4. bilateral renal artery stenosis or renal artery stenosis in a solitary kidney or post-renal transplant
5. current treatment with any antihypertensive agents, whether or not prescribed for this indication, that cannot be safely stopped
6. other conditions or situations that could put potential participants at unacceptable risk due to participation in this study
Milwaukee Day Cares Indoor Air Quality Assessment and Educational Response Study

This CTSI pilot study will assess for benefit of a community health worker or nursing student taught green cleaning curriculum (developed by the local asthma coalition) provided to Milwaukee County day care staff. Consumer grade indoor air quality monitors will be deployed before and after the educational intervention to objectively monitor changes as a result of the intervention. Surveys regarding changes in cleaning practices by day care staff will also be obtained to assess changes resulting from the intervention.

A research and community service partnership of the Medical College of Wisconsin, the Univ. of Wisconsin-Milwaukee School of Nursing and the non-profit asthma coalition Fight Asthma Milwaukee Allies (FAM) was developed to describe and improve health relevant air quality conditions within urban Milwaukee daycare environments. Daycare air quality and the ability of education to improve air quality, both within Milwaukee and elsewhere, has not been extensively studied nor addressed in Wisconsin state law to date.

This project aims to understand the levels of indoor organic pollution and fine particles in the air, as well as temperature and humidity with using inexpensive, consumer-grade, internet cloud enabled continuous indoor air quality (IAQ) monitors. These air quality variables are scientifically established important risk factors for both the development and exacerbation of asthma.

This project aims to train UWM Nursing students, FAM Allies volunteers and MCW staff to teach an established educational programing curriculum developed by FAM Allies to daycare staff. Daycare programs may be motivated to participate in study as the curriculum is approved continuing education credits for daycare staff members.

The FAM Allies curriculum will address understanding of the importance of asthma and IAQ with irritant reduction measures, and safer cleaning and pest-control techniques. Additionally, the program will review the importance of IAQ upon the lungs and review knowledge about asthma.

The proposal is a 4-month intervention in which the IAQ monitor will be placed in daycares to obtain baseline measurements. Half of the facilities will receive education at the second month allowing the team to assess before and after education air quality readings. The rest of the facilities will receive the same education at the third month. After 4 months, the devices will be removed from the facilities and results in aggregate will be shared with the daycare.

Eligibility Criteria:
Inclusion Criteria:

* licensed child day care staff within Milwaukee County
* authorized consent to participate in study by day care organization

Exclusion Criteria:

* medical or adult day care centers
Methylation Biosignature in Childhood Chronic Kidney Disease

Chronic kidney disease (CKD) and end-stage renal disease are highly prevalent in Taiwan. Cardiovascular disease (CVD) is the most common cause of death in children with CKD. Nitric oxide (NO) deficiency links CKD and CVD. Asymmetric dimethylarginine (ADMA), a NO synthase inhibitor, its level is increased in kidney disease and cardiovascular disease and serves as a methylation biomarker.

In addition to ADMA, uremic environment, hyperhomocysteinemia (Hcy) and oxidative stress may affect DNA methylation. S-adenosylmethionine (SAM) is an important human methyl donor. S-adenosylhomocysteine (SAH) is demethylated product. Methylenetetrahydrofolate reductase (MTHFR), a folate metabolism enzyme can regulate methylation pathway.

The investigators intend to examine whether ADMA, SAM/SAH ratio, Hcy, and MTHFR gene methylation can serve as biosignature to predict CVD in children with CKD children.


Eligibility Criteria:
Inclusion Criteria:

* chronic kidney disease stage 1-4
* Volunteer

Exclusion Criteria:

* pregnancy
* renal transplant
* congenital heart disease
* not able to be adherent/complaint with study procedure
* not volunteer