cyrilzakka/clinical-trials huggingface dataset:
Image Guided Intensity Modulated Reirradiation (IG-IMRT) With Cetuximab for Locoregionally Confined Recurrent Head and Neck Squamous Cell Carcinoma

The standard treatment for head and neck cancer relapses in previously irradiated patients is controversial. Reirradiation has had some success, but many patients still die from their disease. Cetuximab is helpful in relapsed head and neck cancer, and it improves the effectiveness of radiation in some head and neck cancer patients. But, it has not been studied with reirradiation. The purpose of this study is to see the effects, both good and bad, of reirradiation with cetuximab.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a pathologically confirmed recurrence (reappearance of previously cleared) squamous cell cancer in the upper aerodigestive tract or a second squamous cell primary. Patients may have experienced more than one recurrence as long as the first recurrence occurred ≥6 months following the end of the prior RT.
* The recurrence or second primary must be confined to the head and neck above the clavicles (loco-regional recurrence).
* The majority (≥75%) of the tumor volume must have been in areas previously irradiated to ≥45 Gy. The previous irradiation must not exceed a maximum of 75 Gy.
* Patients must be at least 6 months from prior radiation therapy.
* If a resection is performed after the diagnosis of recurrence and before enrollment, either microscopic or macroscopic disease must be present (i.e. positive margins or gross residual).
* Karnofsky Performance Status 60-100.
* Granulocytes ≥ 1500/mm3, platelets ≥ 100,000/mm3, bilirubin ≤ 1.5 mg/dl, creatinine ≤ 1.5 mg/dl, within 6 weeks prior to registration.
* Must be able to submit previous radiation records (simulation and portal film if available) in order to assure that cord tolerance is not exceeded.
* Patients must sign a study-specific informed consent form prior to study entry.
* The patient must be between the ages of 18 and 75.

Exclusion Criteria:

* Distant metastases.
* Completely resected recurrence with negative margins.
* Other concurrent invasive malignancies.
* Prior invasive malignancy unless disease free for at least two years (prior in situ malignancies are permissible).
* Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival.
* Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns.
* Previous treatment with cetuximab.
Anticoagulation and Antiplatelet Management During Perioperative Period

the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation.

the investigators hypothesize that patients do not understand these therapies, and that they are poorly undertaken. In some cases, the anesthesiologist does not understand correctly the indication of the treatment due to lack of information and therefore does not know how to adapt it to the medical situation.

the investigators want to investigate these transitions: how were they understood by patients, how were they performed, and how does this affect surgery, postoperative morbidity and mortality?

Anticoagulation for prevention of thromboembolic events will not be studied in this study.

The anesthesia team will not be particularly trained in anticoagulants and antiplatelets management to be close to actual care. In the Hospital the investigators have a guide written in 2013 in order to describe all the cases possible. The "control/ goal group" will be the patients who have undertaken strictly the protocol described for their cases in the guide.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Able to consent
* Taking anticoagulants or antiplatelet drugs in the long term.

Exclusion Criteria:

* Incapacitated adults
* Minor patients
Identification of Undiagnosed Lysosomal Acid Lipase Deficiency

Partners HealthCare maintains a Patient Data Registry (PDR) with information from all patient encounters at Partners HealthCare facilities. We intend to utilize the PDR to identify groups of patient who are of high clinical suspicion for undiagnosed lysosomal acid lipase deficiency. A group of potential participants will be identified through the PDR. Detailed records will be requested to further narrow to ideal participants based upon previously existing diagnoses and symptoms. Participants will be invited to partake in the study via a letter from their Partners care provider with supporting study details. Study participants will be evaluated in a one-time visit. A complete family and medical history will be collected. A physical exam will be performed, and up to 20cc of blood will be drawn. All participants will be notified of their disease status via letter and phone call from the study staff. If the study participant is diagnosed with LALD through this evaluation, proper follow-up recommendations and referrals will be provided. Our intent is to determine if existing patient data can successfully be utilized to aid in the identification of patients with rare genetic disease.


Eligibility Criteria:
Inclusion Criteria:

* Individuals must have records available in the Partners HealthCare Patient Data Registry

Exclusion Criteria:

* Individuals must not have a diagnosis of Lysosomal Acid Lipase Deficiency
12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients

This study was designed to evaluate the renal function comparing Certican based immunosuppressive regimens with two different CNIs (Tacrolimus or Cyclosporin A) versus a standard treatment with Mycophenolic Acid and Tacrolimus in de novo renal transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Patient who had received a primary or secondary kidney transplant
* Patients who were willing and from whom written informed consent was obtained
* kidney allograft with a cold ischemia time (CIT) \< 30 hours
* negative pregnancy test prior to study enrollment

Exclusion Criteria:

--Multi-organ recipients

* former Graft loss due to immunological reasons
* Patients who received a kidney from a non-heart beating donor
* A-B-0 incompatible transplants
* a current Panel Reactive Antibody (PRA) level of \> 20%
* existing antibodies against the HLA-type of the receiving transplant
* a known hypersensitivity/contraindication to any of the immunosuppressants
* Use of other investigational drugs
* Patients with thrombocytopenia (platelets \< 100,000/mm³), with an absolute neutrophil count of \< 2,000/mm³ or leucopenia (leucocytes \< 3,000/mm³), or hemoglobin \< 8 g/dL
* significant mental illness
* history of malignancy during the last five years
* HIV positive
* uncontrolled hypercholesterolemia or hypertriglyceridemia
* drug or alcohol abuse
* pregnant or breast feeding women
OPTIMOX1 in Chinese mCRC Patients

Previous OPTIMOX1 study investigated the use of oxaliplatin discontinuation and reintroduction in a novel stop-and-go strategy. Previously untreated patients were randomly assigned to either FOLFOX4 administered every 2 weeks until progression (arm A) or FOLFOX7 for 6 cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of FOLFOX7 for another 6 cycles (arm B). Data showed that there was no significant difference in median progression-free survival (PFS) and overall survival (OS) between two arms. Furthermore, this study showed lower Grade 3 neurotoxicity rate in arm B (17.9% vs 13.3%, P = 0.12).In order to investigate the efficacy and feasibility of the novel "Stop and go" strategy in Chinese mCRC patients, Prof. Shu Yongqian in JiangShu Province Hospital plans to conduct a randomized controlled study to compare continuous FOLFOX4 vs. FOLFOX4 in a Stop-and-Go Fashion in 1st Line mCRC patients. To avoid the high oxaliplatin dosage related neurotoxicity, FOLFOX4 regimen is chosen in this study.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed adenocarcinoma of the colon or rectum
* Unresectable metastases
* At least one bidimensionally measurable lesion of ≥ 1 cm
* No previous chemotherapy for metastatic disease; Completed at least more than 1 year oxaliplatin therapy for adjuvant treatment
* 18-75 years old
* ECOG 0-2
* Life expectancy greater than 3 months
* Hemogram: WBC≥4.0 X109/L, ANC ≥2 X109/L, PLT ≥100 X109/L, Hb ≥90g/L,
* Adequate Renal Function
* Adequate Liver Function
* Signed informed consent before the treatment

Exclusion Criteria:

* Patients with previous oxaliplatin based adjuvant chemotherapy within 1 Year
* Completely or partially bowel obstruction
* Presence of peripheral neuropathy (CTC\>grade I)
* Severe mental disorder
* CNS metastasis
* With other severe disease: uncontrolled active infectious disease, uncontrolled hypertension, heart infarction within 1 year, uncontrolled high-risk arrhythmia, unstable angina
* With other malignant disease previously or concurrently
* Receive other anti-tumor treatment
* Pregnant or lactating women, or women of child bearing potential without contraceptive method.
MechanO-Chemical Ablation Versus CompreSSion

This study will be looking at the effect of Endovenous Mechano-Chemical Ablation (MOCA) in addition to multilayer elastic compression bandaging vs multilayer elastic compression bandaging only in patients with incompetent great saphenous vein (GSV) and venous ulcers (VU's).

The most severe form of chronic venous disease is venous ulceration with an overall prevalence of about 1% in the adult population. Venous ulcers significantly impair quality of life, and their treatment places a heavy financial burden upon healthcare systems.

To get the ulcer to heal, the current best treatment is to wear a compression bandage with multiple layers, with which about 60% of these ulcers will heal within 6 months.

There is evidence that treatment of the varicose veins by sahenous veins stripping will prevent the ulcer recurrence.

Recent studies have suggested that novel proceduress of superficial truncal reflux elimination, such as foam sclerotherapy or treating the saphenous veins with termal (laser or radiofrequency) ablation to seal it effectively, may help the ulcers to heal more quickly and increase recurrence-free rate. These techniques can be carried out in the outpatient setting and are much better tolerated by patients in comparison to surgery.

At the same time, no studies which compared compression plus endovenous mechanochemical ablation (MOCA) vs. compression alone in chronic venous ulcers have been conducted to date.

The aim of this study is to see whether treatment of varicose veins using MOCA helps with healing.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age \> 18 years.
2. Current leg ulceration of greater than 6 weeks.
3. Great saphenous vein (GSV) incompetence with reflux at least down to the knee level.
4. Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C6.
5. Able to give informed consent to participate in the study after reading the patient information documentation.
6. Ankle Brachial Pressure Index (ABPI) ≥ 0.8.

Exclusion Criteria:

1. Postoperative varicose veins disease recurrence.
2. Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded.
3. Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome.
4. History of pulmonary embolism or stroke.
5. Current anticoagulation therapy (within 7 days of enrollment).
6. Pregnant or lactating women.
Evolution of Pulmonary Capillary Blood Volume

The purpose of this monocentric, preliminary study is to assess the evolution of pulmonary capillary blood volume (Vc), measured by the double diffusion nitric oxide/carbon monoxide (NO/CO) method (Guenard et al.; Respir Physiol 1987), from the starting of the anticoagulant therapy to 6 months after, and to search correlations with the evolution of clinical (dyspnea and results of the 6 minutes walking test), biological (BNP; Troponin), echocardiographic (right ventricular dysfunction, pulmonary arterial pressure) and ventilation/perfusion lung scan data.


Eligibility Criteria:
Inclusion Criteria:

* Patient with a first episode of symptomatic pulmonary embolism, treated with anticoagulant
* Age from 18 to 75 years-old

Exclusion Criteria:

* Confirmed pulmonary embolism in the past
* Massive pulmonary embolism, thrombolytic treatment
* Confirmed left heart systolic dysfunction
* Confirmed asthma, chronic obstructive pulmonary disease or pulmonary fibrosis
* Expected life below 6 months
* Pleural effusion with indication of evacuation
* Bronchopulmonary cancer
* Pulmonary surgery with resection of two lobes minimum
* Predictable incapacity to complete the 6 minutes walking test
Clinical Evaluation of the Combination of Symptoms and Symptoms With General Treatment for Acute Hemorrhagic Stroke

Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage.

Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote hematoma absorption or reduce perihematoma cerebral edema in patients with intracerebral hemorrhage

Objective To evaluate whether Xingnaojing injection combined with Naoxueshu oral liquid can significantly improve the clinical outcome of patients with intracerebral hemorrhage.

Secondary objectives included to evaluate whether combined application of Xingnaojing injection and Naoxueshu oral liquid can promote hematoma absorption or reduce perihematoma cerebral edema in patients with intracerebral hemorrhage Statistical Methods: The main effective outcomes will be based on a generalized linear model and adjusted for associated confounders.

Eligibility Criteria:
Inclusion Criteria:

* ① It meets the diagnostic criteria of primary cerebral hemorrhage.

  * Within 72 hours of onset.

    * National Institutes of Health Stroke Scale (NIHSS) score ≥4 points.

      ④ Glasgow Coma Scale (GCS) score \&gt; Eight points.

      ⑤ Age 18-80. Patient or legal representative informed consent, and sign informed consent.

Exclusion Criteria:

* (1) known to Xingnaojing, cerebral hemorrhage or related drug ingredients allergic.

  * The patients with previous stroke history and remaining sequelae affected the outcome assessment, that is, the modified Ranking scale (MRS) score before the onset of stroke was ≥2 points.

    (3) known by amyloid cerebrovascular disease, vascular malformation, aneurysm, blood coagulation dysfunction, anticoagulation and antiplatelet drug treatment, thrombolysis therapy, bleeding after infarction after conversion, haematology, moyamoya disease, primary or metastatic tumor, venous sinus thrombosis, and vascular inflammation caused by clear etiology of patients with cerebral hemorrhage or primary intraventricular hemorrhage.

(Note: "After anticoagulant or antiplatelet therapy" refers to patients with intracerebral hemorrhage following anticoagulant and antiplatelet therapy, and these patients were excluded from this study.) (4) Patients with traumatic cerebral hemorrhage. (5) patients with active gastrointestinal ulcer or other definite tendency of rebleeding.
Influence of Hygiene-dietetic Habits and Treatment Adherence on the Effectiveness of the Gastroesophageal Reflux Illness Treatment With Rabeprazol

The objective of this Observational study is to evaluate hygiene-dietetic habits as co-adjuvant treatment of the pharmacologic therapy use to treat Gastroesophageal Reflux.

Gastroesophageal Reflux illness is a multifactor pathology with a common mechanism: a prolonged exposure of the esophageal mucosa to the gastric solutions. Modification of the life style and the hygiene-dietetic habits are frequently recommended as an initial therapeutic instrument in Gastroesophageal Reflux pathology. But there is not agreement about the effectiveness of these habits in the improvement of the illness. Different clinical practice guidances have shown contradictions in the effectiveness of changing hygiene-dietetics habits of the life style. The high effectiveness of the new pharmacologic treatment in Gastroesophageal Reflux pathology make it necessary to review the role of hygiene-dietetic habits in this illness. Proton pump inhibitors (PPI) act in the final step of the gastric secretion. PPI's block ATP-ase H+/K+ in gastric parietals cells. This mechanism generates a higher acid inhibition, longer than the inhibition produced by H2-receptor antagonists. It has been described that inhibition of acid secretion has produced a recovery of the gastroesophageal pathology in a high percentage of the patients resistant to conventional drugs. This is an observational, multicenter, open and prospective study. The primary objective is to evaluate hygiene-dietetic habits as co-adjuvant of Rabeprazol treatment in Gastroesophageal Reflux . It is expected to include 570 patients with Gastroesophageal pathology erosive or non-erosive and acute or chronic treated with Rabeprazol per clinical practice, 20mg per day, orally, for 8 weeks. All data collected will be prospective and will include the following: demographic data, progress of the pathology, change of hygiene-dietetic habits, treatment adherence, concomitant treatments and adverse events. Observational Study - No investigational drug administered

Eligibility Criteria:
Inclusion Criteria:

* Patients with Gastroesophageal pathology erosive or non-erosive and acute or chronic treated with Rabeprazol per clinical practice

Exclusion Criteria:

* Patients pregnant or lactating
* Other gastrointestinal pathologies
* Intestinal or gastric survey
* Other severe concomitant pathologies
* Drug abuse or use of NSAIs (Non-Steroidal Anti-Inflammatories) more than 3 days/week
The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients

1. To evaluate the consistency of cardiac output measured by pulmonary artery catheter and LiDCO in cardiac surgical patients
2. To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes

Close monitoring of cardiac output (CO), especially in patients before and after intervention(such as volume expansion, diuresis, vasoconstriction, vasodilation therapy), could help to adjust the treatment strategy in cardiac surgical patients. Pulmonary artery catherization (PAC) has been used for hemodynamic monitoring for more than four decades. In spite of its invasiveness, it remains the clinical reference method for the assessment of CO at the bedside. Nowadays, many less invasive alternatives, such as LiDCO Rapid Pulse Contour Analysis System (LiDCO Ltd., Cambridge, United Kingdom), are already available on market. However, consistency between different hemodynamic monitoring results still raise concern. And whether hemodynamic monitoring could accurately detect the changes of these parameters before and after intervention is an important issue in clinical practice. In this study, the investigators are going to collect CO and changes of CO from PAC and LiDCO before and after intervention (passive leg raising and dobutamine stress test) in cardiac surgical patients. Our resulst could provide important reference for cardiac surgical patients how to choose appropriate hemodynamic monitoring tools and how to interpret the results of hemodynamic monitoring.

Eligibility Criteria:
Inclusion Criteria:

1. cardiac surgery
2. hemodynamic monitoring (PAC, LiDCO)
3. mechanical ventilation

Exclusion Criteria:

1. cardiac arrhythmia
2. moderate to severe aortic, mitral and tricuspid regurgitation
3. IABP
4. ECMO
Effects of Spirulina Supplementation on Mental Health in Healthy Adults

Spirulina platensis is a form of cyanobacteria, a blue-green algae, and is a superfood most known for being rich in protein, vitamins and minerals, and healthful phytochemicals. Spirulina supports brain health through neuroprotection offered by its antioxidants, anti-inflammatory properties, and hormone regulation.

The aim of this study is to supplement healthy adults from a campus community with 3g of spirulina, daily, for 8 weeks to improve mood and mental acuity in comparison to receiving a placebo.

Spirulina is nutrient-dense with vitamins and minerals which provide antioxidants and anti-inflammatory mechanisms to help reduce oxidative stress and ROS activity. Preclinical studies have indicated Spirulina can reduce inflammatory cytokines, such as IL-1β, and reverse stress responses and oxidative damage in BDNF, nuclear factor erythroid 2-related factor (NRF2), and ultimately the phosphorylation of protein-kinase B (AKT), which promotes cell growth. In addition to these benefits, fatty acids, gamma-linolenic acid (GLA) and glycolipids, support gut health and the immune system. In combination, all these nutrients help increase neuroprotection and brain health.

It is evident that Spirulina supports brain health through neuroprotection, antioxidants, anti-inflammatory properties, and hormone regulation. Research supports Spirulina reversing neurodegenerative diseases due to several of these beneficial properties. There have been many studies that utilize Spirulina to improve cognitive function in Alzheimer's Disease, Parkinson's Disease, ulcerative colitis, IBD, fibromyalgia and even in TBI and Ischemic stroke.

Although many of these diseases have depressive symptoms, few of these studies have evaluated the impact of Spirulina on mood. Furthermore, no studies have been conducted relating depression and the cyanobacteria. It is possible that Spirulina supplements can be used to reduce feelings of hopelessness and lack of energy, by providing additional vitamins, minerals, amino acids, and fatty acids, on a daily basis. This study aims to compare spirulina and its improvement on mood, in health college students, by daily supplementation of 3g of Spirulina over a span of 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

Healthy adults ages 18-65 with no underlying chronic disease or acute conditions, no autoimmune conditions, and who do not consume alcohol in excess, smoke, use recreational drugs or follow restrictive diets, will be recruited from the ASU university campus.

Exclusion Criteria:

Participants will not have been clinically diagnosed with depression or take any antidepressants, anxiety, or stress medications, or any other medications, drugs, or supplements that could influence mental capacities. Volunteers are excluded if pregnant or breastfeeding because there is not enough data to confirm the safety of Spirulina in pregnant or breastfeeding women. Competitive athletes will also be excluded. -