cyrilzakka/clinical-trials huggingface dataset:
Inpatient Self Monitoring and Administration Study (ISMAS)

ISMAS is designed to test the hypothesis that self management of insulin dependent diabetes mellitus by selected patients admitted for elective surgery is more efficacious than standard care with respect to overall glycemic control, attaining finger-stick blood sugars, and administering insulin.


Eligibility Criteria:
Inclusion criteria:

1. Male or female, age \< 80
2. Most recent hemoglobin A1C within the past 6 months \< 12%
3. Recent history of regular self-administered peripheral blood glucose checks as an outpatient
4. Recent history of insulin self-administration at least twice a day as an outpatient
5. Admitted for a hospitalization anticipated to last at least 3 days
6. Mini Mental Status Examination (MMSE) ≥ 25 at admission and the same or better post-operatively
7. All patients will be actively followed by the Endocrinology inpatient consultation team during the hospitalization.

Exclusion criteria:

1. Currently receiving peritoneal or hemodialysis
2. Patients with unstable angina
3. History of myocardial infarction within 3 weeks prior to enrollment
4. Current admission due to or associated with altered mental status or encephalopathy
5. History of an episode of altered mental status or encephalopathy within the 4 weeks prior to enrollment
6. A confirmed diagnosis of dementia
7. Inability to self-adjust insulin
8. No recent history of ability to perform regular peripheral blood glucose checks
9. Frequency of hypoglycemia (\< 60 mg/dL) \> twice/week by history
10. Inability to eat without assistance
11. Study objectives will not be pursued in patients during stays in any intensive care unit.
Trial Comparing Simple Follow-up to Exploratory Laparotomy Plus "in Principle" (Hyperthermic Intraperitoneal Chemotherapy) HIPEC in Colorectal Patients

Multicentric randomised trial. Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC) after resection of their primary will be informed, will sign the consent and will be pre-registered. All patients will receive the current standard adjuvant treatment : 6 months of systemic chemotherapy (currently the Folfox-4 regimen which could be modified if the standard is modified). Then a work-up is done to exclude recurrence. The likelihood of a recurrence is low but if this occurs, the patient will not be randomised and will be treated with the best known treatment. If the work-up is negative, patients will be randomised to surveillance alone (control group) or exploratory laparotomy + HIPEC (experimental group).


Eligibility Criteria:
Inclusion Criteria:

A) Patients presenting with the following history:

1. Histologically-proven colorectal adenocarcinoma
2. Presenting at the time of resection of the primary with one of the following 4 criteria (criteria indicating a high risk of developing PC) :

   * Minimal PC, resected at the same time as the primary
   * Ovarian metastases
   * Rupture of the primary tumour inside the peritoneal cavity,
   * Iatrogenic rupture of the primary tumour during surgery

B) Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :

* Chemotherapy with the Folfox 4 regimen (the current standard treatment ; it can be modified in the future in the two groups, if the standard is modified...).
* Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons...);

C) Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy.

D) Patients with the following general characteristics:

1. Age between 18 and 70 years,
2. Performance Status WHO \< 2, life expectancy \> 12 weeks,
3. Haematological parameters : Polynuclear neutrophils ³ 1.5x109/L, platelets ³ 100x109/L,
4. Liver function : Total Bilirubin £ 1.5 x ULN, AST (SGOT) et ALT (SGPT) £ 3 x ULN, alkaline phosphatases £ 3 x ULN,
5. Renal function : Plasma creatinine £ 1,25 x ULN,
6. Operable patients,
7. Grade £ 2 peripheral neuropathy (CTC AE v3.0 annex 7)
8. Patients entitled to French National Health Insurance coverage.

E)Patients will be informed and a signed consent form will be obtained before initiating any procedure specific to the trial.

Exclusion Criteria:

1. Cancers of non colorectal origin, particularly, appendiceal cancers are excluded
2. Patients presenting with a detectable recurrent tumour
3. Grade ≥ 3 Peripheral neuropathy
4. History of cancer (excepted cutaneous basocellullar cancer or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
5. Patients already included in another trial concerning first-line treatment 6) Pregnant women or likely to be pregnant

7) Persons under guardianship 8) Follow-up impossible for geographic, social or psychological reasons
Effect of Sclerotherapy on Fistulas and Sinus Tracts in Hidradenitis Suppurativa

This study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.

The clinical effect of the hypertonic saline treatment will be evaluated with Physician Assessments at week 2 (t=2), week four (t=4) and week 8 (t=8) and compared with the first visit (baseline) (t=0). If necessary, subjects will be eligible to receive another hypertonic saline injected in week 2 and/or week 4, with a maximum of three injections. Simultaneously improvement will be assessed by ultrasound if possible, using the Philips Lumify Ultrasound Device, and by patients using HS Improvement Assessments. Pain and stinging during treatment sessions will be monitored using numeric rating scales (NRS). For monitoring quality of life the DLQI will be used.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects are at least 18 years of age or older
* A confirmed diagnosis of HS disease
* Presence of inflammatory HS lesion(s) and one or more fistula(s) or sinus tracts

Exclusion Criteria:

* Receiving any other kind of treatment for fistulas including introduction of anti-inflammatory systemic therapy such as prednisone or adalimumab within the prior month.
* Are participating in another study using an investigational agent or procedure during participation in this study.
* Are currently pregnant or planning to get pregnant during the study.
* Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
Nutrition-Focused Quality Improvement Program (QIP) Among Community Dwelling Malnourished Patients

This study aims to assess the malnutrition prevalence of Colombian community-dwelling adults and evaluate the feasibility of a nutrition-focused QIP implemented in a Colombian ambulatory care facility on healthcare utilization.


Eligibility Criteria:
Inclusion Criteria:

* Patient is screened as being malnourished or at risk for malnutrition
* Patient can consumer beverages and food orally
* Patients have a life expectancy of equal or greater than 90 days
* Patient is literate and willing to voluntarily sign and date an Informed Consent Form (ICF) after it is explained

Exclusion Criteria:

* Patient is pregnant
* Patient is intubated, receiving tube feeding or parenteral nutrition
* Patient has severe dementia, delirium or history of significant psychiatric disorder and no dedicated caregiver who could assure their compliance with QIP study requirements and help with the completion of QIP study materials
* Any other disorder that may interfere with QIP product consumption or compliance with QIP protocol procedures
* Patient has an allergy or intolerance to any of the ONS ingredients
* Patients does not want to participate or sign ICF
* Patient is bedridden or confined in a wheelchair
Aloe Vera on Irradiated Breast Tissue

The investigators are testing two over the counter aloe veras on irradiated breast tissue.


Eligibility Criteria:
Inclusion Criteria:

1. Women over 18 years of age who had undergone lumpectomy or partial mastectomy for breast cancer, and who then received postoperative radiation therapy using tangential fields, with or without a boost to the tumor bed. Chemotherapy as part of the treatment regimen was acceptable.
2. No major medical or psychiatric illness that might interfere with patient's completion of study requirements
3. Signed study-specific informed consent form prior to study entry

Exclusion Criteria:

1. Those requiring nodal radiation therapy were excluded.
2. Subjects who have a breast infection at the commencement of radiation treatment
3. Before randomization, subjects who have agreed to participate are asked if they are allergic to any topical preparation. Those allergic to aloe vera were ineligible.
Efficacy and Safety Study of Pegasys in the Treatment of Chronic Hepatitis B

The purpose of this study is to determine the safety and efficacy of Pegasys + placebo + lamivudine versus lamivudine alone in patients with lamivudine versus lamivudine alone in patients with hepatitis B antigen CHB.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of hepatitis B
* Not pregnant

Exclusion Criteria:

* Treatment for hepatitis B in past 6 months
* Other hepatitis infections
* Severe liver disease
* Pregnancy
Comparison of Trelstar Versus Lupron or Zoladex in Advanced Prostate Cancer

This research study looks at Testosterone levels in patients receiving Trelstar versus those receiving Lupron or Zoladex. These drugs have been approved for treatment of Prostate Cancer by the FDA.

Patients who are currently receiving Lupron or Zoladex will be consented and then randomized to receive either continued treatment with the drug they have been on, or will be randomized to Trelstar for a period of 3 months. At the end of that period, testosterone and prostate serum antigen (PSA) levels will be drawn and compared to their previous levels to determine if Trelstar is as effective as the previous treatment.

Eligibility Criteria:
Inclusion Criteria:

* Advanced Prostate Cancer
* Currently taking Lupron or Zoladex
* Stable PSA
* Baseline testosterone below castration level
* Life expectancy \> 6 months
* Eastern Cooperative Oncology Group performance status of 0-2
* Signed, approved informed consent.

Exclusion Criteria:

* Known hypersensitivity to any leuteinizing hormone releasing hormone (LHRH) agonist
* Ongoing therapy with hyperprolactinemic agents
* Antiandrogen therapy within 28 days prior to study start
* Prior Orchiectomy, hypophysectomy or adrenalectomy
* Chemotherapy, radiotherapy, or prostatectomy within 28 days prior to study start
* Use of any investigational agent 3 months prior to enrollment
* Use of systemic corticosteroids within 28 days or during study
* Other malignancies within 2 yrs prior to study start, except curatively treated skin cancers
* Severe kidney or liver failure, based on adequate lab values
* Other medical conditions which would be likely to interfere with compliance or completion of study requirements
IMGN529 in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

The purpose of this study is to test the safety and tolerability of IMGN529 in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL).


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory NHL including tumor types: Follicular lymphoma (FL), marginal zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL).
* Adequate organ function
* ECOG ≤ 2
* Recovered or stabilized from prior treatments.

Exclusion Criteria:

* Allogeneic stem cell transplantation
* Pregnant or lactating females
* Known central nervous system, meningeal or epidural disease including brain metastases
Evaluation of Residual Neuromuscular Blockade and of Late Recurarization in the Post Anesthesia Care Unit in Patients Undergoing Videolaparoscopic Cholecystectomy

Neuromuscular blockade is essential to provide optimal conditions for tracheal intubation and also to facilitate the performance of surgeries involving mainly the abdominal cavity. The introduction of neuromuscular blockers in clinical practice optimized the execution of mechanical ventilation. Since the use of these drugs, increased intercurrences such as prolonged muscle paralysis and respiratory complications have been observed, resulting in unfavorable outcomes with residual neuromuscular blockade and delayed recurrence due to the occurrence of these complications. The present study aims to evaluate the incidence of residual neuromuscular blockade and late recurarization in the post-anesthetic recovery room in patients submitted to videolaparoscopic cholecystectomy.

This is an observational and prospective study in which patients aged 18-50 years classified as ASA (American Society of Anesthesiologists) I and II, body mass index below 35 and who will undergo cholecystectomy will be included. Patients will be allocated to two groups based on the neuromuscular blocker used by the anesthesiologist who participates in the surgery, ie in group C patients will participate in the administration of cisatracurium and the group R will consist of the patients in whom rocuronium was administered. General anesthesia and assessment of muscle function will be performed by measuring the four-stimulus sequence (SQE) / train of four (TOF) at pre-established times. A residual neuromuscular block is considered to be the patient presenting the value of the four-stimulus sequence of T4 / T1 of less than 0.9.

Eligibility Criteria:
Inclusion Criteria:

* Patients submitted to videolaparoscopic cholecystectomy under balanced general anesthesia. ASA (American Society of Anesthesiologists) patients, class I and II, age group of 18 to 50 years, body mass index below 35.

Exclusion Criteria:

* Patients ASA III or higher; ASA II patients with respiratory comorbidities. Patients with neuromuscular diseases or severe renal or hepatic diseases. Patients submitted to total venous anesthesia. Patients with body temperature below 36 ° C. Replication of the neuromuscular blocker. Use of drugs that accentuate neuromuscular blockade such as calcium channel blockers, inorganic ions (Mg ++, Li ++), aminoglycoside antibiotics, halogenated anesthetics (except sevoflurane), local anesthetics (except lidocaine), benzodiazepines and opioids (except morphine or remifentanil) .
Lifting of Gastric Tube Through Trans-substernal Versus Trans-esophageal Bed Path in MIE

Esophageal cancer (EC) is the eighth most common cancer and the sixth leading cause of cancer deaths worldwide. Minimally invasive esophagectomy (MIE) is regarded as a safe and effective management for resectable EC. Gastric tube is considered to be an ideal substitute for the resected esophagus and can be lifted to the neck for anastomosis through two different paths - Trans-substernal and trans-esophageal bed routes. However, the differences of operative outcomes between the two paths have not been systematically described. In this study, clinical outcomes including intra- and post-operative status, morbidity and complications, nutrition status, as well as quality of life after surgery will be evaluated, and differences between the trans-substernal and trans-esophageal bed groups will be compared. The study might help to individualization treatment for EC.

1. Patients with esophageal cancer (EC) will be histologically proved by endoscopic biopsy, and staged by thoracicoabdominal computed tomography (CT), endoluminal ultrasonography and positron emission tomography (PET) before surgery. The other crucial test including barium meal, pulmonary function tests, arterial blood gas analysis, cardiac ultrasonography, electrocardiogram and treadmill test, as well as blood biochemistry examinations will also be accomplished preoperatively.
2. Patients who meet clinical criteria will be asked to sign a consent form, and divided randomly into two groups - trans-substernal group and trans-esophageal bed group. Patients in both groups will undergo a minimally invasive esophagectomy which consist of 4 steps: (1) thoracoscopic esophageal mobilization followed by mediastinal lymphadenectomy; (2) laparoscopic gastric mobilization followed by abdominal lymphadenectomy and gastric tube construction; (3) cervical esophageal mobilization and transection; (4) lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path. The operative procedure of the two groups is similar except step 4.
3. Patients in both groups will be followed-up regularly. Intra- and post-operative status, morbidity and complications, nutrition status, as well as quality of life after surgery will be evaluated, and differences between the trans-substernal and trans-esophageal bed groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus.
* Surgical resectable (T1-4a, N0-3, M0).
* Age ≥ 18 and ≤ 75 years.
* European Clinical Oncology Group (ECOG) performance status 0,1 or 2.
* Written informed consent obtain

Exclusion Criteria:

* Carcinoma of the cervical esophagus.
* Carcinoma of the gastro-esophageal junction (GEJ).
* Prior thoracic surgery or trauma on the right hemithorax, or previous diseases which may lead to right pleural adhesion (these patients will undergo open surgery instead of minimally invasive esophagectomy).
* Dysfunction of cardiorespiratory system or other surgical contraindications.
Diaphragmatic Speckle Tracking During Spontaneous Breathing Trial

Currently, measurement of transdiaphragmatic pressure (Pdi) using oesophageal and gastric balloons is the gold standard for the assessment of diaphragmatic effort. This technique is relatively invasive and its interpretation may be complex. The diaphragmatic longitudinal strain (LSdi) and strain rate (LSRdi) might provide additional information in the assessment of diaphragmatic effort and movement during SBT, allowing early detection of diaphragmatic dysfunction. Patients will be monitored during a 30-120 minutes SBT consisting of no assistance on the ventilator using CPAP with a pressure level of 0 cmH2O. Parameters to evaluate diaphragm function will include diaphragmatic strain (LSdi and LSRdi), diaphragmatic thickening fraction (TFdi), and airway occlusion pressure (ΔP0.1 and ΔPocc). These parameters will be measured immediately before ('baseline') the SBT, as well as 2 minutes ('early' assessment), 15 ('intermediate' assessment) and 30 minutes ('late' assessment) after the beginning of the SBT.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult patients (≥18 years old) undergoing mechanical ventilation for at least 24h (regardless of the reason of intubation)
* patients fulfilling criteria for an SBT
* patients will have to be able to trigger ventilator breaths with a reasonable level of assistance,
* patients with lack of severe impairment in gas exchange,
* patients that not require significant hemodynamic support.
* Patients will be recruited by the study coordinator following completion of informed consent from the patient or legally authorized substitute decision maker.

Exclusion Criteria:

* Use of pressure support during the SBT.
* Severe hemodynamic instability (\>30% increase in vasopressors in the last 6 hours or norepinephrine \> 0.5 µg/kg/min).
* Severe or very severe chronic obstructive pulmonary disease (COPD) according to the GOLD criteria (stage III: FEV1 30-50% predicted; stage IV: FEV1 \< 30% predicted).
* Known or suspected severe or progressive neuromuscular disorder likely to result in prolonged or chronic ventilator dependence
* Clinical judgement of the attending physician.
Reduced Antithrombotic Strategy for High Bleeding Risk Patients With Myocardial Infarction

Rationale: Heart attacks are a major cause of death and result from coronary blood clots that require acute coronary intervention and antithrombotic drugs to restore blood flow and prevent new heart attacks. Over time, more potent antithrombotic drugs have been introduced like prasugrel and ticagrelor. These drugs have replaced the older drug, clopidogrel, as approximately 30% of patients are low-responders to clopidogrel for genetic reasons. However, the newer drugs introduce a significant risk of serious bleeding.

Aim: The aim of this trial is to assess a reduced antithrombotic strategy for high bleeding risk patients with heart attacks to reduce bleeding safely.

Hypothesis: Significantly reduced bleeding with a similar preventive effect are expected.

Design: The Dan-DAPT trial include high bleeding risk patients with heart attacks from Danish hospitals (Rigshospitalet, Aarhus, Odense, Aalborg, Roskilde, and Gentofte hospital) and randomize them to standard-of-care or shorter and individualized antithrombotic therapy based on responsiveness to clopidogrel after genetic testing.


Eligibility Criteria:
Inclusion Criteria:

1. MI caused by atherothrombotic CAD (Type 1 MI) according to "The Fourth Universal Definition of MI", which has been treated with PCI with contemporary drug-eluting stents. This definition of type 1 MI requires the detection of a rise and/or fall of cardiac troponin values with at least one value \>99th percentile and at least one of the following criteria assessed by the treating physician:

   * symptoms indicating acute myocardial ischemia
   * new ischemic changes on the electrocardiogram
   * development of pathological Q-waves
   * imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology
   * visible coronary thrombus by angiography
2. PRECISE-DAPT score ≥25
3. Age ≥18 years

Exclusion Criteria:

1. Contraindications including allergies to ASA or P2Y12 inhibitors
2. Indication for oral anticoagulation
3. Previous stent thrombosis
4. Life expectancy \<1 year
5. Resuscitated cardiac arrest with Glasgow Coma Scale \<8 and/or need of intubation
6. Prior intracranial hemorrhage
7. Active bleeding (BARC ≥2) at randomization
8. Women who are pregnant, have given birth recently (within the past 90 days), are lactating, or are fertile without contraception
9. Hypertensive crisis (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>120 mmHg)
10. Unable to understand and follow study-related instructions or to comply with study protocol