cyrilzakka/clinical-trials huggingface dataset:
Extracorporeal Support for Respiratory Insufficiency (ECMO)

To evaluate indications for the use and efficacy of extracorporeal membrane oxygenators (ECMO's) for the support of patients with potentially reversible acute respiratory failure.

BACKGROUND:

The report of the Task Force on Respiratory Diseases identified a clinical syndrome of acute respiratory insufficiency (ARI) and estimated that approximately 60,000 Americans die of ARI yearly. ARI was not precisely defined; indeed, the Task Force realized that pathologists do not recognize ARI. The Task Force pointed out that no diagnostic tests for early detection of ARI exist, that the incidence and prevalence of the disease are not known, and that existing therapy is supportive and nonspecific (diuretics, corticosteroids, etc.). The pathogenesis of the syndrome, the mechanism of interstitial edema, the defenses of the lung against agents causing ARI, and the ultrastructural pathology and natural history of the disease were virtually unknown. The Task Force indicated a need for Respiratory Care Centers with highly trained personnel that could reduce mortality from ARI.

This clinical trial grew out of the Task Force report. Nine participating centers defined ARI in clinical and physiological terms and agreed to a prospective randomized study for 3 years to compare treatment of severe ARI by conventional means with treatment by extracorporeal membrane oxygenators.

Animal studies have shown that ECMO's can provide one to two weeks' support for the lungs without serious blood damage, in contrast to bubble oxygenators, which allow complete pulmonary bypass for approximately 6 hours, after which severe blood damage occurs at the direct blood-gas interface. If patients with hypoxia secondary to acute reversible lung injury can be supported with ECMO's until the lung lesion heals, improvement in survival rates and avoidance of the hazards of conventional therapy may result. The trial, now completed, was conducted at nine clinical centers in the United States.

DESIGN NARRATIVE:

Randomized, non-blind, fixed sample; 90 eligible patients were randomly assigned to a group receiving extracorporeal membrane oxygenation plus conventional therapy or to a group receiving conventional therapy.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Eligibility Criteria:
Men and women, ages 12 to 65, not stratified as to ethnic group, who had potentially reversible acute respiratory failure.
Extended Pouch Roux-en-Y Gastric Bypass Study

Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity.

The objective of this study is to investigate the effect of a restrictive/extended pouch on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that the restrictive/extended pouch results in more weight reduction.

The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (normal pouch) and restrictive/extended pouch RYGB.


Eligibility Criteria:
Inclusion Criteria:

Patient eligible for bariatric surgery according Fried guidelines

Primary Gastric bypass

* BMI 35 - 40 with a comorbidity
* or BMI \> 40

Exclusion Criteria:

* Exclusion criteria for bariatric surgery (Fried Guidelines)
* Patients with language problems that interveins to follow medical advises
* Genetic diseases that intervens to follow medical advises
* Chronic bowel diseases
* Nephrologic (MDRD \<30) of liver diseases (AST/ALT more than twice the norm)
* Pregnancy
ddcfDNA in Kidney Transplant Recipients

The objective of this study is to predict subclinical Antibody-Mediated Rejection (ABMR) occurrences in de novo DSA-positive recipients maintaining stable renal function after transplantation. This will be achieved through the measurement of donor-derived cell-free DNA. The utility of donor-derived cell-free DNA will be validated based on histological findings using Receiver Operating Characteristics (ROC) curve analysis.


Eligibility Criteria:
Inclusion Criteria:

* Recipients aged 18 and above
* Patients with de novo DSA positivity post-kidney transplantation and stable renal function: De novo HLA DSAs encompass both class I and class II, with Mean Fluorescence Intensity (MFI) greater than 1000. Stable renal function is defined as serum creatinine variation of less than 15% compared to the last 6 months.
* Patients with detected de novo HLA-DSAs but did not undergo histological examinations.

Exclusion Criteria:

* Multi-organ transplant recipients
* Recipients with positive preformed DSAs
* ABO-incompatible transplant recipients
* Pediatric recipients under 18 years old at the time of transplantation
* Recipients lost to follow-up observation
* atients already subjected to histological examinations due to positive De novo HLA-DSAs.
Virtual Sailing Simulator in Individuals With Spinal Cord Injury

The research is being done to look at the benefits of a recreational and therapeutic program for people with spinal cord injury using the VSail-Access sailing simulator.

The VSail-Access is the first sailing simulator available for people with disabilities. The VSail-Access simulator is a variation on the VSail where the cockpit is fitted with a seat. The VSail simulator is a generic sailboat cockpit powered by a pneumatic ram and custom designed software. The sailor sails the simulator around virtual courses displayed on a computer screen in the same way as a real sailboat on water. Electronic sensors provide real time feedback to match the movements of the virtual sailboat displayed on the screen with those of the simulator. Sailors can select wind strength and conditions to suit their ability.

Adults with spinal cord injury may take part in this study.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females, age 18-65 years, all ethnic groups.
* Spinal Cord Injury.
* Chronic injury, \> 6 months from the injury.
* All ASIA neurological levels (C1-S1)
* All ASIA impairment scale A-D .
* Subjects are able to comply with procedures and follow-up.
* Subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues.

Exclusion Criteria:

* Cardiovascular disease as defined by previous myocardial infarction, unstable angina, requirement for anti platelet agents, congestive heart failure, or stroke NYHA Class III or IV, history of arrhythmia with hemodynamic instability.
* Uncontrolled hypertension (resting systolic BP \> 160mmHg, or diastolic BP \> 100mmHg consistently).
* Severe hypotension (systolic BP \< 80 mmHg, or diastolic BP \< 55 mmHg).
* Ventilator dependent subjects.
* Significant cognitive impairment.
* History of epileptic seizures.
* Unstable long bone fractures of the extremities.
* Subjects having Stage III or greater skin ulcerations.
* Active sailor.
* Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
Nefopam/Paracetamol Fixed Dose Combination in Acute Pain After Impacted Third Molar Extraction

This study aims to evaluate the analgesic efficacy of single and multiple doses of a new fixed dose combination of nefopam hydrochloride 30 mg and paracetamol 500mg taken orally in comparison to each single component.


Eligibility Criteria:
Main Inclusion Criteria:

* Male and female patient aged from 18 years up to 65 years,
* Patient scheduled to undergo the surgical removal of at least one fully or partially impacted third mandibular molar requiring bone removal under short-acting local anaesthetic (mepivacaine or lidocaine) with or without vasoconstrictor,
* Patient weighing \> 50 kg,
* Patient who has signed a written informed consent prior to any study-related procedures.

Additional inclusion criteria after surgery (randomization):

1. Patient experiencing moderate to severe pain within 4 hours after the dental extraction, defined by a baseline pain intensity Visual Analogic Scale (VAS) score ≥ 50 mm,
2. Third molar extraction(s) completed without any immediate complication, that in the opinion of the investigator, would interfere with the study conduct and/or assessments (e.g., suspected neurosensory complication, incomplete removal of tooth)

Main Exclusion Criteria:

* Patient treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days preceding the day of randomization or within 5 times the elimination half-life whichever the longest,
* Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception,
* Patient with a history of convulsive disorders,
* Patient taking mono-amine-oxidase (MAO) inhibitors (including but not limited to selegiline, isocarboxazid, tranylcypromine, phenelzine...),
* Patient with an abnormal cardiac condition: medically significant disorders of cardiac rate and/or rhythm,
* Patient with known anaemia,
* Patient with known pulmonary disease,
* Patient with known active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding,
* Patient with known glaucoma,
* Patients with a prostatic hyperplasia or urinary retention,
* Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities,
* Patient with a current or chronic history of severe renal impairment (glomerular filtration below 30 mL/min),
Mesh Fixation With a Synthetic Glue in Primary Inguinal Hernia Repair

Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran 2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The investigators aim is to recruit 150 patients for the study.

The outcomes The investigators would like to determine are : postoperative pain,recurrences and complication rates such as seromas.

Prospective observational study with mesh fixation using FDA approved synthetic glue,glubran 2 and standard mesh fixation with stiches in primary inguinal hernia repair surgery. The investigators aim is to recruit 150 patients for the study.

The outcomes The investigators would like to determine are : postoperative pain,recurrences and complication rates such as seromas.

Eligibility Criteria:
Inclusion Criteria:

* Primary Inguinal hernia

Exclusion Criteria:

* Recurrent hernia
* Large inguinoscrotal hernias
* Bilateral inguinal hernias
Curcumin Paste as an Adjunctive Therapy in Periodontitis

The turmeric (Curcuma longa) plant, a herb belonging to the ginger family. The most active component of turmeric is curcumin, which makes up 2 to 5% of the spice. Curcumin showed has antibacterial effect against periodontal pathogen and positive result regarding conventional treatment of periodontal disease due to its anti-inflammatory, anti-oxidant and wound healing properties. This study will be carried out to examine the effect of curcumin when used in conjunction with open flap debridement treating deep periodontal pockets. (suggesting that it may have positive effect)

The present study entailed twenty four patients having stage II or stage III, Grade A periodontitis with 24 intrabony defects. Patients were divided into two groups; group I was subjected to open flap debridement only. Group II was subjected to curcumin paste (2%curcumin)in conjunction with open flap debridement Clinical parameters including plaque index, sulcus bleeding index, probing depth and clinical attachment level were recorded pre-surgical. Moreover, radiographic examination was performed by cone beam computed tomography (CBCT) just before the surgery . Vertical bone defects were exposed by full thickness mucoperiosteal flap following intrasulcular incision and thorough debridement was performed. Group II received local application of curcumin paste.The same initial clinical parameters were recorded three and six months postoperatively. Radiographic measurements were recorded six months post surgically.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female with age range 25-45 years.
2. At least a single posterior 2-3 wall periodontal defect of pocket depth ≥ 5mm; clinical attachment level ≥ 3 mm, Intrabony component ≥ 3 mm and with plaque index ≤1 (Löe 1967) and bleeding index ≤1 (Mühlemann \& Son 1971). All the previous criteria were determined 2 weeks after phase I conventional periodontal therapy.
3. Systemically Healthy as evidenced by Burket's oral medicine health history questionnaire (Glick et al., 2008).

Exclusion Criteria:

* 1- Smokers. 2- Pregnant. 3- Patient unwilling to comply to periodontaloral hygienic instructions. 4- Vulnerable groups. (e.g: Decisionally impaired individual)
PainSquad+: A Smartphone App to Support Real-time Pain Management for Adolescents With Cancer

Adolescents with cancer (AWC) are in a unique developmental stage that may mean pain characteristics, the impact of pain, and pain treatment outcomes are different in adolescents compared to children and adults. In response, we will develop and test the PainSquad+ pain management smartphone app. First, we will conduct usability testing to refine PainSquad+ so that it is useable, acceptable and understandable for AWC. Secondly we will: (a) test the feasibility of conducting a large-scale PainSquad+ experiment and (b) begin to examine how effective PainSquad+ is at helping adolescents manage pain. We hope that once developed and tested for effectiveness, PainSquad+ will improve pain treatment and ultimately quality of life in AWC.

Using a conservative estimate of 7 adolescents per cycle and 3 testing cycles, 21 adolescents will take part in usability testing of the PainSquad+ prototype. Recruitment will be conducted in a single hematology/oncology division of a metropolitan and university-affiliated pediatric tertiary care center in Toronto, Canada. This site hosts one of the largest cancer programs in North America, with approximately 350 new diagnoses each year. Based on our previous research at this site, 72 ± 4% (M ± SD; range = 67-75%) of eligible AWC agreed to participate in similar studies (unpublished data). Convenience sampling will be used to recruit eligible individuals. The testing procedures will commence after eligibility is assessed, informed consent is obtained, and demographic and baseline outcome data are collected. Inclusion criteria will be: (a) aged 12-18 years, (b) able to speak and read English, (c) actively undergoing cancer treatment on an in- or out-patient basis, (d) being at least 3 months from diagnosis and (d) having self-reported pain of any intensity in the week immediately prior to recruitment. Exclusion criteria will be: (a) one or more major co-morbid (medical or psychiatric) conditions that would preclude use of a smartphone, and (b) palliative/end-of-life patients.

Eligibility Criteria:
Inclusion Criteria:

* aged 12-18 years,
* able to speak and read English
* actively undergoing cancer treatment on an in- or out-patient basis
* being at least 3 months from diagnosis
* having self-reported pain of any intensity in the week immediately prior to recruitment

Exclusion Criteria:

* one or more major co-morbid (medical or psychiatric) conditions that would preclude use of a smartphone
* palliative/end-of-life patients.
Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

To evaluate the efficacy of intravitreal bevacizumab injections for treatment of proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after previous full panretinal photocoagulation (PRP).

The investigators will carry out a prospective study in patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes will be treated with intravitreal injection of bevacizumab (1.25 mg). Complete ophthalmic examination and/or ocular ultrasonography will be performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection. Re-injection will be done in non-clearing and recurrent VH.

Eligibility Criteria:
Inclusion Criteria:

* patients with diabetes mellitus
* proliferative diabetic retinopathy
* prior complete panretinal photocoagulation
* presented with new dense vitreous hemorrhage

Exclusion Criteria:

* one-eyed patient
* previous intraocular surgery
* severe lens opacity precluding fundus examination
* advance glaucoma
* history of thromboembolic events such as myocardial infarction and cerebrovascular accident
* uncontrolled systemic hypertension, systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg
* known coagulation abnormalities or current use of anticoagulant medications other than aspirin
* known allergies to any relevant drugs in this study
* evidence of external ocular infection such as conjunctivitis and significant blepharitis.
Prevalence of Alpha-1 Antitrypsin Dysfunction in Pulmonary Emphysema

The main objective of this trial is to evaluate the prevalence of alpha-1 antitrypsin quantitative and functional deficiency in an adult French population presenting with pulmonary emphysema. Phenotypic and genotypic studies will be carried whenever quantitative and/or functional deficiency will be displayed.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary emphysema highlighted by computed tomography
* Ratio Forced Expiratory Volume in 1 second (FEV1) / Vital Capacity (VC) \< 70% measured by lung function test

Exclusion Criteria:

* Hepatic transplant
* Patient under legal protection
* Patient not benefiting from the French Health Insurance
Real-world Effectiveness Evaluation of Clinical Decision Support System Based on Artificial Intelligence (AI-CDSS)

This study intends to explore the accuracy of clinical diagnosis of AI based CDSS system and promotion of clinical work by comparing CDSS before and after the online.

This study intends to explore the accuracy of clinical diagnosis of AI based CDSS system and promotion of clinical work by comparing CDSS before and after the online. The difference of diagnostic accuracy before and after AI-CDSS application will be compared by the before and after design, and the role of AI-CDSS will be explored.

Eligibility Criteria:
Inclusion Criteria:

* all hospitalized patients in 6 clinical departments, Otolaryngology, Orthopaedic, Respiratory Medicine, General Surgery, Cardiology and Hematology from December 2016 to February 2019.

Exclusion Criteria:

* Missing data for key variables
PrOtamIne doSing clOt imagiNg (POISON) Study

The proposed study involves using two different high-resolution microscopic imaging techniques to examine the health and platelet invasion of clot in patients who were given 1:1 protamine / heparin and compare this to clot from patients who had heparin reversed using the PRODOSE algorithm. Patients will be treated according to the routine clinical practice of their individual care team.

Sample collection at RPH

Patients will have a total of 14ml of blood taken during the procedure.

The first 7ml will be taken after induction of anaesthesia along with routine blood gas and coagulation sampling through the routinely indwelling arterial catheter. The initial sample must be taken before any heparin has been administered. This will be used to fill 2 x 3.5ml citrated (green top) blood tubes. These will be clearly labelled as "pre-heparin" with a Tissue Bank ID number.

The second 7ml will be taken 5 minutes after heparin has been reversed with protamine after cessation of cardiopulmonary bypass. It will again be taken at the same time as routine sampling for blood gas and coagulation studies. Analog to the first sample, it will again be divided and used to fill 2 x 3.5ml citrated (green top) blood tubes. These will be clearly labelled as "post-protamine" with the same ID number and whether "1:1" or a "PRODOSE algorithm determined" protamine: heparin ratio was used.

In keeping with clinical routine, ROTEM coagulation testing and full blood counts will be requested as seen necessary by the clinical team.

The samples will be sent to Royal Papworth Hospital (RPH) Tissue Bank for initial processing. Samples need to be processed within 4 hours of blood draw.

After initial processing, samples will be sent for confocal imaging to the MRC Laboratory of Molecular Biology (LMB) and for SEM imaging to the University of Oxford respectively.

Clinical data to be collected (to be completed by anaesthetic team).

1. Demographic information: Age / Gender / Weight / Height / Medication history;
2. Type of surgery;
3. Cardiac drug history and antiplatelets / anticoagulants and timing;
4. Coagulation tests (ACT / ROTEM) at the following points: a) Pre-heparin, b) Post-heparin, pre-CPB, c) Throughout CPB, c) Post-protamine;
5. Full blood count at the following points: a) Pre-surgery and date of sample, b) Post-protamine; 6) CPB and x-clamp times, nadir temperature

Eligibility Criteria:
Inclusion Criteria:

* undergoing elective, uncomplicated single procedure cardiac surgery with anticipated CPB duration \< 120 min
* with all anticoagulant drugs stopped at least 5 days before surgery, apart from aspirin
* with normal full blood count and clotting screen pre-OP.

Exclusion Criteria:

* emergency surgery
* inability to stop anticoagulants except aspirin for 5 days pre-OP
* complex surgery with anticipated CPB duration \> 120min
* operations planned to be done at temperature on CPB \< 34 degrees
* operations requiring deep hypothermic circulatory arrest, solid organ transplantation
* know blood dyscrasia
* intra-operative blood or blood product transfusion or post-operative coagulopathy
CAFE Comparison of Atypicals in First Episode of Psychosis

The purpose of this study is to compare the effectiveness, tolerability, and efficacy of the currently available atypical antipsychotic drugs olanzapine (2.5-20 mg/day), quetiapine (100-800 mg/day) and risperidone (0.5-4 mg/day) in patients with schizophrenia, schizophreniform disorder, or schizoaffective disorder who are experiencing their first psychotic episode.


Eligibility Criteria:
Inclusion Criteria:

* Patients must meet criteria for schizophreniform disorder, schizophrenia, or schizoaffective disorder with psychotic symptoms lasting 1-60 months
* Psychotic symptoms must have persisted at least one month, and not more thn 5 years (60 months)
* Patients must have no previous history of drug treatment (greater than a total of 16 weeks) with antipsychotics

Exclusion Criteria:

* Patients with history of psychotic disorder with recovery period of at least 3 months
* Female patients who are pregnant or nursing
* Patients with a known history of mental retardation
Enhancing Complex Care Through an Integrated Care Coordination Information System

Cluster randomized controlled trial comparing care coordination incentives to pay for performance (quality measure) incentives in clinics on utilization, cost, quality, and patient experience.


Eligibility Criteria:
Inclusion Criteria:

* Six Clinics participating whom Care Management Plus team has worked with before
* Patients belonging to one of these six clinics
* Picked based on an algorithm designed to identify high risk patients.
* Clinic will review potential patients list and issue a survey with consent form

Exclusion Criteria:

* Younger than 18
* Older than 90