cyrilzakka/clinical-trials huggingface dataset:
Platelet Rich Plasma vs. Corticosteroid Injection in the Treatment of Partial Rotator Cuff Tears

The purpose of this study is to further define the optimal non-surgical treatment strategy for partial thickness rotator cuff tears. The specific aim of this study is to determine the outcomes of treatment of partial thickness rotator cuff tears with corticosteroid or platelet rich plasma (PRP). Subjects with partial thickness rotator cuff tears will be randomized to receive an injection of PRP or corticosteroid. Shoulder function and tendon healing will be evaluated using the patient surveys as well as ultrasound. Subjects will be followed for one year to determine the outcomes for each treatment. The hypothesis is that there is no difference in healing rate or functional outcomes in patients treated with corticosteroid injections vs. PRP injections for the treatment of partial thickness rotator cuff tears.


Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain for at least two weeks.
* Partial thickness articular sided rotator cuff tear diagnosed by MRI and musculoskeletal ultrasound.

Exclusion Criteria:

* Prior surgery to the injured shoulder
* Full thickness rotator cuff tear
* Pregnancy
* Cancer
* Current treatment with anticoagulation medication
* Steroid injection in the past 6 months in the injured shoulder
* Prior PRP treatment to the injured shoulder
iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients

Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia

Febrile neutropenic patients suspected of sepsis will follow the conventional infectious diagnosis work-up over the entire observation period, and will be tested in addition with iDTECT Blood on Study Day 1.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 5 years and weight \> 16 Kg
2. Patients having signed the written study informed consent form (ICF) prior to any study-mandated procedure. For children/adolescents: ICF obtained from both children's parents/ legal representative prior to any study-mandated procedure, and in addition for adolescents (13-17 years): assent form to be signed
3. Patient presenting severe neutropenia (absolute neutrophil count \< 0.5 Giga/L) anticipated to be long lasting (\> 10 days) following intensive chemotherapy for acute myeloid or lymphoid leukaemia (AML or ALL) or myelodysplastic syndrome or in the context of hematopoietic stem cells transplantation
4. Febrile episode (oral temperature \> 38.3°C once, or 2 measures \> 38.0°C taken 2h apart).

Exclusion Criteria:

1. Known HIV infection or AIDS diagnosis
2. Already microbiologically confirmed infection
3. Patient status preventing the study test to be performed
4. Patient with an obvious infectious disease diagnosis requiring minimal additional microbiological documentation or confirmation
Waterjet Versus Ultrasound Dissection During Hepatic Transection

Before liver transection patients are allocated to either waterjet or CUSA to divide the liver parenchyma.

Transection time, bloodloss, total operation time and postoperative complication rates are registered.

Eligibility Criteria:
Inclusion Criteria:

* Hepatic tumour suitable for resection
* patients 18 year or older Segmental resection Local resection Left sided hemihepatectomy

Exclusion Criteria:

* Right sided hemihepatectoyReresection In Situ Split Liver Extended left- and rightsided hemihepatectomy Lobus caudatus resection Central resections Hilus tumour/Klatskin/Cholangiocarcinoma Surgery on biliary tree Extended resection on other organs

Resection on gallbladder Resection on other organs during the same operation.
Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing

The present study evaluates the effects of to compare bactericidal efficacy using the reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub method in order to test if pass the standard european norm 12791.

The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by rub and scrub. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

Eligibility Criteria:
Inclusion Criteria:

* Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
* They do not use substances with antibacterial action.

Exclusion Criteria:

* Taken antibiotics before 10 days of the intervention.
* Wear any jewellery on the hands.
A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a

Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRIÂ®) or Interferon beta-1a (AVONEXÂ®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple Sclerosis (RRMS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RRMS.
* Patients with unilateral AON consistent with Multiple Sclerosis (MS).
* Treatment with intravenous methylprednisolone (IVMP) at 1gm daily for three days after the onset of AON, without a taper, and completed within 14 days of the AON symptom onset.
* Age 18-55 years.
* Expanded Disability Status Scale (EDSS) 0 to 5.0.
* Understand and sign informed consent.

Exclusion Criteria:

* History or presence of progressive multifocal leukoencephalopathy (PML).
* Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Secondary Progressive Multiple Sclerosis (SPMS).
* Immune-compromised in the judgment of the Investigator.
* History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator or Sponsor, would preclude participation in the study.
* Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc).
* Previous history of severe disc edema, hemorrhage, or \> 1 confirmed optic neuritis (ON) with the most recent ON symptom onset being less than 12 months ago.
* Previous treatment with \> 1 Disease Modifying Therapy (DMT).
* Previous treatment with investigational products for MS, immunosuppressant or cytotoxic therapy.
* Previous treatment with TYSABRI®
* Women who are not postmenopausal, surgically sterile, or willing to practice contraception.
* Women pregnant, breast feeding, or planning to become pregnant.
* Involved with other study protocol simultaneously without prior approval.
* Determined not suitable for study participation by Investigator and/or Sponsor.
Explore the Effectors of The Transtheoretical Model on Nutritional Education in Patients on Hemodialysis

The purpose of this study is to assess the improvement degree of nutritional care program on the nutritional status and eating habits of hemodialysis patients

After being informed about the study and potential risks, all patients giving written Informed consent will undergo a 1-week screening period to determine eligibility For study entry. At week 0, eligible patients will be assigned to the intervention group and the control group by single-blind manner(participant) with convenience sampling. In the intervention group, the patients were trained in The Transtheoretical Model on nutritional education for 8 weeks. In the control group, the patients were trained in roution nutrition education.

Eligibility Criteria:
Inclusion Criteria:

1. the biochemical value ≥ 5.5 mg/dl or albumin value\<3.8g/dL
2. BMI\<23kg/m2
3. Unexpected weight loss.
4. Must be able to swallow tablets

Exclusion Criteria:

1. Clinical diagnosis of Alzheimer's Disease
2. Malignant tumors, gastrointestinal cachexia, and catheterization
Effects of Soy Protein/Soy Fiber on Measures of Satiety

The purpose of this study is to determine whether ingestion of a bar containing either added soy protein or soy fiber or both, increases subjective and objective measures of satiety compared to a control bar.

The study will use a randomized, double blind crossover design in which subjects act as their own control. Satiation will be assessed using a Motivation to Eat Questionnaire. Height and weight will be measured at the screening visit and weight alone at each subsequent visit. Prior to consumption of the test meal (breakfast) and at 15, 30, 60, 90, 120 and 150 min thereafter, subjects will complete a VAS Motivation to Eat Questionnaire. After subjects complete the first VAS motivation questionnaire, they will be given the test meal and instructed to eat this over a 15 minute period and fill out a palatability questionnaire. Two hours after the start of the test meal they will be taken to a private feeding room, where an ad libitum pizza lunch will be served with mineral water. Participants will be instructed to eat and drink as much as they desire until they are comfortably full. Subjects will be asked to fill out a final VAS Motivation to eat questionnaire 30 min after the start of the pizza meal.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 20 and 30 kg/m2
* Age between 20-60y
* Unrestrained eater (score\<15)
* Regularly consume 3 meals per day
* Moderate exercise (eg running , aerobics classes, other sports activities) of no more than 7 hours per week

Exclusion Criteria:

* use of drugs that influence carbohydrate or lipid metabolism (eg betablockers,hypoglycemic agents, antibiotics taken less than 6 weeks before study entry, glucocorticoids, anti-diarrheal medication, weight loss medication etc), and anti-diabetic medication
* presence of any significant disease (eg gastrointestinal diseases, diabetes, a CVD event less than 12 weeks from study entry, current hepatic disease etc)
* use of special dietary treatments or supplement within 4 weeks of study
* restrained eater (score\>15)
* weight change (±10% of body weight) within the previous 6 weeks
* alcohol intake \>2 drinks/day
* food allergies of any kind
* swallowing difficulties,
* exercising more than 7 hours per week
Role of Health Education in the Semipresential Logopedic Treatment of the Patient With Oropharyngeal Dysphagia

When reviewing the literature, the need to investigate the health education of patients with dysphagia and their family members / caregivers has been detected. Numerous articles mention or it can be inferred from them that an education or training has been carried out for the patient and caregivers, but the investigators have not found any that specifically focuses on this aspect of the intervention. Only in some Clinical Practice Guidelines is the need for health education included


Eligibility Criteria:
Inclusion Criteria:

* People between 18 and 99 years old diagnosed by videofluoroscopy of oropharyngeal dysphagia and who are candidates for speech therapy treatment for this reason.
* Knowledge of the language sufficient to understand the audiovisual material on health education available at: logopediasantpau.wordpress.com
* Have the necessary technological tools to carry out the telematic processing (electronic device with Internet access and WhatsApp) and know how to use them or have a family member / direct caregiver with basic technological skills.
* Signature of the informed consent

Exclusion Criteria:

* Moderate or severe cognitive impairment already known from the medical history or evaluated with the MoCA test in the absence of a family member or caregiver.
* Having undergone speech therapy treatment for oropharyngeal dysphagia in the last year.
* Not signing the informed consent.
Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)

This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There will be 6 scheduled clinic visits and 2 treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides \< 500 mg/dL

Exclusion Criteria:

* Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) \>/= 130 mg/dL and/or not on a statin
* Patients with diabetes and LDL-C \>/= 130 mg/dL. Patients with \>/= 2 heart disease risk factors and LDL-C \>/= 160 mg/dL.
* Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.
Open Label of Clinical Trial of Sulforaphane in Children With Autism

This is an open-label, 4-month study examining the effects of Sulforaphane (SF) on behavior in children with ASD and the correlation between behavior change and urinary metabolites. The goal is to determine a potential mechanism of action of SF in this population.

Sulforaphane (SF) is an isothiocyanate found in high levels in crucifers belonging to the family Brassicaceae (including broccoli, cabbage, cauliflower, brussels sprouts, Chinese cabbage and turnips). Many previous studies have documented that consumption of these vegetables is associated with a reduced risk of cancer (lung, breast, colon, rectum, and prostate).(Juge et al. 2007) The mechanism of action of these beneficial effects is believed to be due to the ability of SF to up-regulate genes that improve cellular response to oxidative stress, inflammation, DNA-damaging electrophiles, and radiation.(Singh et al. 2014) In a recent small, randomized controlled trial in children with autism, SF was shown to have beneficial effects on aberrant and social behavior.(Singh et al. 2014) The mechanism of action of this beneficial effect has not been established in children with ASD. Our primary goal is to examine changes in urinary metabolites in children with autism who receive SF to determine if changes in behavior are associated with changes in urinary metabolites.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, enrolled at OHS, age 6-22 and with a diagnosis of ASD.
* ASD diagnosis will be established by standard criteria (DSM-IV criteria and expert clinician review of medical records and child observation).
* Written informed consent obtained from the subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Routine Evaluation of the Social Determinants of Health in Oncology: User-centered Resource Coordination and Engagement

The purpose of this research is to understand how screening for patient resource needs followed by customized resource matching can improve outcomes for adults with breast, lung or gastrointestinal cancer.

This research study is an intervention assessment; this is the first-time investigators are examining the impact of screening for resource needs followed by customized resource matching at Dana-Farber Cancer Institute.

* The research study procedures include screening for social determinants of health (resource) needs and, depending on study group, resource matching.
* Participants will be randomized into one of two groups.

  * Usual Care or Usual Care with customized resource matching.

It is expected that about 125 participants will take part in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will be adults age 18 or older, able to consent, scheduled for a new patient consultation in DFCI BOC, TOP or GCC. To select for patients from demographic groups vulnerable to SDoH needs, two different groups will be eligible to participate.
* Group A

  * BIPOC (Black, Latinx, Native American or Pacific Islander)
  * LEP Spanish-speaking (As indicated by the EHR)
  * Low SES (from zip code with median household income \<$32,000/year) OR
  * Age 70+
* Group B

  * Any one NPIQ response indicating SDoH need
  * Health literacy/numeracy, Caregiving/relationships, OR Finances

Exclusion Criteria:

- Group A and B

-- Patients not continuing care at Dana Farber Cancer Institute
Arterial Stiffening as a Predictor for Diastolic Cardiac Dysfunction and HFpEF

Patients at risk for developing heart failure with preserved ejection fraction (HFpEF) will undergo a structured clinical assessment, transthoracic echocardiography and pulse-wave analysis to investigate the association of arterial stiffening and the development of cardiac diastolic dysfuntion and HFpEF.


Eligibility Criteria:
Inclusion Criteria:

One or more of the following criteria:

* Age \> 60 years
* Arterial hypertension (RR systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg or ≥ 2 antihypertensive drugs)
* Diabetes mellitus Type I or II
* Atrial fibrillation
* Chronic kidney disease (GFR \< 60 ml/min/1,73 m2 or urine albumin ≥ 30mg/24h or ACR ≥ 30 mg/g)
* BMI ≥ 30 kg/m2
* NYHA ≥ II
* E/e' \> 8

Exclusion Criteria:

* Left ventricular ejection fraction \< 50 %
* Significant valve disease (Grade III or higher)
* History of interventional or surgical valve repair
* Regional wall motion abnormalities
* Respiratory diseases as a known cause for dyspnea
* Atrial flutter or fibrillation during examination
* Hypertrophic/restrictive/arrhythmogenic/dilatative cardiomyopathies including cardiac amyloidosis or sarcoidosis and toxic cardiomyopathy
* History of heart transplantation
Investigation of Three Contraceptive Hormone Patches in Regard to Inhibition of Ovulation Following Application Over 3 Treatment Cycles in Healthy, Young Women.

The primary objective of this trial is to examine whether ovulation is suppressed after use of hormone patches containing different dosages of ethinyl estradiol (EE) and gestodene (GSD) for 3 treatment cycles. To this end, the blood levels of endogenous hormones (hormones produced by your body) will be measured and transvaginal ultrasound examinations will be conducted at regular intervals. In addition, the concentrations of the administered hormones EE and GSD in blood will be determined in regular intervals.

With regard to the tolerability of the hormone patches subjects will be asked regularly how they feel and blood pressure, pulse and body weight will be determined. In addition, blood and urine safety examinations will be conducted at defined timepoints.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers
* age 18 - 35 years (smoker not older than 30 years, inclusive)
* ovulatory pre-treatment cycle

Exclusion Criteria:

* Contraindications for use of combined (estrogen/gestodene) contraceptive (e.g. history of venous or arterial thromboembolic disease)
* Regular intake of medication other than Oral Contraception
* Clinically relevant findings (blood pressure, physical and gynecological examination, laboratory examination)
Ischemic Conditioning of the Gastric Conduit in Esophageal Cancer.

This study is a randomized clinical trial to clarify if preoperative embolization of gastric arteries can reduce the incidence of oesophagogastric leakage after an esophagectomy for esophageal cancer comparing an experimental group vs control group.

In patients with infracarinal esophageal carcinoma, the surgery is a complex procedure and with a high morbidity. It consists of a subtotal esophagectomy with tubular gastroplasty and cervical esophagogastric anastomosis. The most important complication is the anastomotic leakage with a high mortality. Among the possible causes of anastomotic leakage an important factor is the impaired microcirculation in the anastomotic region after the partial devascularization of the stomach during the surgery. There are several experimental studies about the different techniques to improve this vascularization and their effects on mucosal oxygenation. There are several methods currently used for assessing tissue oxygenation. The polarographic partial pressure of oxygen (pO2) electrode has been considered as the 'gold standard' for measuring oxygen tension. This is the reason why tissue pressure of oxygen (PtiO2) will be measured by Licox® (Integra Neuroscience) system in two groups. There aren't prospective randomized controlled trials to answer these questions. For this reason the investigators propose to perform a prospective randomized controlled trial in patients underwent on this surgery, comparing two groups: one of them will be carried out a preoperative arterial embolization (PAE), and the other one will be operated directly, to demonstrate if the ischemic conditioning by PAE can reduce the incidence of anastomotic esophagogastric leakage and improve the gastric conduit oxygenation.

Eligibility Criteria:
Inclusion Criteria:

* All patients requiring a esophagectomy with cervical esophagogastrostomy for esophageal cancer
* 18 or above years old
* Karnofsky\>50%
* Acceptance and signing the full informed consent

Exclusion Criteria:

* Fistula tracheobronchial
* Metastatic disease
* Anatomic vascular alteration that contraindicate the embolization (congenital celiac trunk stenosis, presence of arcuate ligament, atherosclerotic stenosis, etc,..)
* Severe cardiorespiratory failure
* Refuse to collaborate in the study
The Effect of Esketamine Combined With Pregabalin on Chronic Postsurgical Pain in Patients After Craniotomy.

Chronic postsurgical pain (CPSP), which is one of the most common and serious long term complication of surgery，occurs in approximately 10% of patients after a surgical procedure. Craniotomy was previously considered to have less chronic pain than other surgical procedures. Contrarily, studies have reported incidences of chronic headache varies for type of craniotomy, ranging from 23% to 34% at three months and 12% to 16% at one year after surgery. In addition，CPSP is associated with adverse events, including postoperative morbidity, increased health-care costs, significant impaired on quality of life, prolonged opioid use. Optimising perioperative pain management should reduce the incidence of CPSP; The non-opioid analgesics, such as ketamine and pregabalin, have also been used as components of multimodal anesthetic protocols. Postoperative pain scores and opioid use are significantly reduced in thoracotomy surgical patients given ketamine and pregabalin compared to control groups.however, there is currently a lack of evidence regarding which therapeutic options are most effective in reducing the incidence of chronic post-craniotomy headache. The investigators hypothesis is that sketamine combined with pregabalin reduces significantly chronic postoperative pain after craniotomy and improves patient outcome.


Eligibility Criteria:
Inclusion Criteria:

* Adults, age ≥18 years, male or female
* American Society of Anaesthesiology (ASA) status I-III
* Patients undergoing elective craniotomy

Exclusion Criteria:

* Patients unable to complete scale assessment
* Pregnant or lactating women
* Patients with preoperative chronic pain syndrome
* Patients with previous craniotomy history
* Patients with a history of mental illness who are receiving medication
* Patients with liver and kidney dysfunction
* Patients have taken pain medication within two weeks
* Patients with history of adverse reactions to pregabalin, ketamine and esticketamine
* Patients with history of drug abuse;
* BMI\>35.0 kg · m - 2.